While the drug wholesaling industry appears reasonably healthy right now, the ongoing generic drug price war among retail pharmacies will create the risk of reduced wholesaler profitability. Understanding this dynamic is crucial for predicting the future of wholesaler relationships with manufacturers and pharmacy customers.

Total revenues from the drug distribution divisions of the three largest wholesalers were $255.8 billion in calendar year 2008, up 5.8% versus calendar year 2007. Although profit margins have come down in recent years, operating cash flows are up sharply since wholesalers began reducing inventory levels in 2003. Wholesalers have used the extra cash flow to buy back about $15 billion of shares, repay debt, and fund acquisitions. Return on Assets (ROA) has increased in part because the ROA denominator (inventory assets) has dropped sharply. 

Drug wholesaler revenues are linked most closely to sales of brand drugs at retail pharmacies. Revenue growth from these products will slow during the next five years as an estimated $70 billion of current branded product revenues is converted to generic revenues during the next four years. 

Despite the revenue impact of brand sales, more than 60% of drug wholesalers’ gross profits come from generic drugs. The coming wave of generics should provide an initial boost to wholesaler profitability because generic drugs offer higher gross profit margins to wholesalers. Wholesalers also have the opportunity to earn higher returns on invested capital because generic inventory costs reduces balance sheet inventory assets compared to an equivalent amount of branded drugs. 

	However, there will be countervailing pressure on wholesaler’s profit margins from generics as the pharmacy industry changes. The ongoing consolidation of the pharmacy industry pressures wholesaler profit margins from generic drug distribution. The top six dispensing pharmacies — CVS Caremark, Walgreens, Medco Health Solutions, Rite-Aid, Wal-Mart, and Express Scripts – now account for more than half of all dispensed prescriptions. 

The biggest chains act as their own wholesaler because they have developed self-warehousing capabilities for distributing drugs to individual stores from the retailer’s own warehouses. They typically bypass wholesalers to buy generic drugs directly from manufacturers, although most chains still use drug wholesalers for the warehouse logistics of brand drugs. 

Right now, pharmacies are fighting a retail price war over certain generic drugs. Wal-Mart launched its $4 generic drug program in September 2006. Non-pharmacy retail chains — supermarkets and other mass merchants – quickly followed Wal-Mart’s move. These retailers have been able to absorb lower generic margins because pharmacy represents a minority of their sales and gross profits. In 2008, the three large pharmacy chains were forced to respond and launch their own low-cost generic programs. 

Discount generic programs have two primary effects on wholesalers. One, we believe that retail market share is shifting away from wholesaler-supplied dispensing channels, especially independents, small chains, and other non-self-warehousing retailers. Independent pharmacies, which rely on drug wholesalers for 98 percent of their drug purchases, are an ever-smaller part of drug dispensing. Two, pharmacy customers require more aggressive pricing from wholesalers in order to remain competitive with the larger chains that are buying directly from manufacturers. 

Pressure on generic pharmacy profits will also increase as payers learn more about channel economics. When generic dispensing rates (GDR) were 20%, payers did not pay much attention to the costs or margins associated with generic drugs. But GDRs are almost 70% and rising, which means that pharmacy channel costs and margins for generic drugs will be increasingly seen as a mechanism to control drug spending. The large volume of upcoming generics will focus even more payer attention on hidden economics of the channel, such as the profits on generic drugs earned by wholesalers and others.

Adam J. Fein, Ph.D., is president of Pembroke Consulting, a management advisory and business research firm. He writes the popular industry blog www.DrugChannels.net. This article is adapted from Dr. Fein’s 2009 Economic Report on Pharmaceutical Wholesalers. 

Articles

Drug Wholesalers and the Generic Price War

	As supply chains seek to become more environmentally friendly, reverse logistics is taking on a broader scope. No longer positioned as just a means for handling product recalls and returns, the industry is adding “green” to the bottom line by offering pharmaceutical companies more sustainable and cost-effective methods for shipping back unsold Rx drugs from hospitals and pharmacies.

“From a recall perspective, the industry is continually facing changing regulatory requirements and increased scrutiny,” says Mike Rozembajgier, marketing manager at Stericycle (Lake Forest, IL), a business services and consulting firm specializing in, among other things, medical waste disposal and pharma recalls. He notes FDA is increasing field investigators around the globe to assist in protecting people against the severe damage that can be caused by non-compliance. “Overall, recalls are on the rise, and yet there is limited knowledge and awareness about the true impact that a recall of any size can have on companies from both a liability and brand perspective, especially when there is no recall plan in place.” 

Experts concur that new and pending environmental requirements are a big reason why reverse logistics, once an afterthought in pharma, is now being taken quite seriously. Two bills introduced earlier this year in the House of Representatives to amend the Controlled Substances Act are seen as having a direct impact on consumer take-back programs, which have been hampered by the need to involve law enforcement to handle controlled substances. The Safe Disposal Act of 2009 (HR 1191), introduced by Congressmen Inslee (D-WA) and Moran (D-VA), would provide for disposal of controlled substances by ultimate uses and care takers through state take-back disposal programs. The Secure and Responsible Drug Disposal Act of 2009 (HR 1359), introduced by Congressmen Stupak (D-MI) with Smith (R-TX), provides for disposal of controlled substances in specific instances.

	“There’s certainly an opportunity for our business in helping all segments of the pharmaceutical supply chain, including consumers, dispose of pharma products safely,” says Carrie K. Griffiths, director of corporate communications at WM Waste Management (Houston), a provider of trash and waste removal, recycling, and environmentally safe waste management services. 

Both bills were referred to the House Committee on Energy and Commerce and House Committee on the Judiciary. 

Meanwhile, the U.S. Environmental Protection Agency (Silver Spring, MD) is reportedly proposing the addition of “pharmaceutical wastes” to the federal Universal Waste Program, a move that would facilitate implementation of drug take-back programs on a wide scale. “These take-back programs would result in a decrease in the disposal of pharmaceutical wastes in municipal solid waste disposal facilities,” says Robert Schaltenbrand, director of strategic development, Guaranteed Returns (Holbrook, NY). “Guaranteed Returns is participating on an industry committee that is currently evaluating the entire rule.” 

These and other proposed state and federal environmental regulations all have a financial impact on reverse logistics. The Reverse Logistics Executive Council (Reno, NV), an association of practitioners and academics, estimates reverse logistics costs account for approximately one-half of 1% of U.S. GDP. Throw in the patient-safety concern when a controlled substance is recalled — in an industry where 100% recovery is rarely achieved even for highly unsafe products – and you have the makings of a potentially painful hit to the bottom line if recalls and returns are not handled adequately.

“Current conditions are also requiring companies to focus more directly on core initiatives, many times leaving reverse logistics on the backburner,” contends Tom Marcellino, EVP, business development, Inmar CLS MedTurn (Winston-Salem, NC), a provider of reverse logistics and supply chain management systems to the consumer goods and healthcare markets. “Yet, the most important activity overlooked is an understanding that the reverse supply chain can contribute profits. And that many times outsourcing provides the focus and the profitability that otherwise would be overlooked when not a core competency.” 

	With ever-changing regulatory requirements associated with healthcare products, experts emphasize the importance of pharma companies to ensure all aspects of drug recalls and returns are handled safely and cost-effectively. While the reverse side of the supply chain typically represented only 1% to 2% of total sales, in a suffering economy, every penny counts. “Manufacturers are looking at ways to minimize returns, match credits closer to actual value, expose inefficiencies in the returns process, and continue competitive return policies,” Marcellino says. 

These and other factors are reportedly leading to additional emphasis being placed by reverse logistics providers on environmentally benign disposal practices. These companies claim they are well positioned to take all of the necessary steps involved in collecting and recycling of drug packages sent back to the manufacturer as a result of either recalls (where there is an FDA-mandated, or manufacturer-originated, retrieval of already shipped product) or returns (when out-of-date product is sent back to the manufacturer by agreement) to ensure an environmentally safe method of recovery. “Guaranteed Returns has and continues to support all environmental programs that local, state and federal agencies have established over the years to ensure the proper destruction and disposal of hazardous and non-hazardous waste material,” Schaltenbrand says. 

Along the same lines, Stericycle reports it processed millions of pounds of waste-to-energy incineration in the U.S. last year, diverting non-hazardous specialty waste from being disposed of in landfills. “Stericycle offers creative solutions to provide eco-friendly disposal alternatives — such as recycling, separation of hazardous /non-hazardous components, and reuse - for manufacturers’ non-performing assets,” Rozembajgier says. “As a result of Stericycle’s Pharma Pail program at retail pharmacies in Canada, thousands of pounds of post-consumer pharmaceutical returns waste are being kept out of landfills or wastewater treatment systems.” 

Stericycle recently acquired Strong Pharmaceutical Services, a division of Strong Environmental, which was formed to meet the unique disposal needs of the drug manufacturing industry. Strong specializes in managed destruction of clients’ pharma waste in a focused and responsible manner. “Stericycle and Strong can provide a variety of destruction services from standard non-hazardous, non-controlled waste to biologic, hazardous waste, both via incineration,” Rozembajgier explains. “A specialty waste analysis can also be performed to create solutions for unique waste situations.” 

On the packaging side of the pharma business, environmental solutions are being developed that enable drug makers to reuse containers, saving them money and minimizing waste. A case in point is Entropy Solutions (Minneapolis), which offers a reverse logistics model that ensures a pharma customer’s purchased or leased temperature-management shipping system significantly minimizes packaging waste and drives down shipping and logistics costs. The Greenbox line features a reusable design which is said to provide customers with up to 100 times of reuse, and created with 100% recyclable, organic-based, non-toxic and fully biodegradable components.

Earlier this year, the thermal technology development company expanded the Greenbox line of temperature-controlled shipping products by introducing Pallet Shipper, capable of shipping 16 ft(3) of temperature-sensitive pharmaceuticals or biologics, and reusable more than 250 times. “Until now there have been very limited choices when it comes to shipping large quantities of temperature-sensitive goods, either traditional cardboard/gel pack shippers or expensive aluminum ones,” noted Eric Lindquist, president, “With our Greenbox Pallet Shipper, we are able to provide them durability

	and longevity while being extremely cost-effective.” 

	While a large component of handling a drug recall is the physical processing and disposition of the product, even more important is tracking and information exchange of the recall data. Extensive government regulations and reporting requirements, along with an increased focus on pedigree, have increased the need for good tracking, visibility and control measurements, industry watchers say. These are all critical components for any reverse logistics process. 

Nonetheless, a number of technical and business obstacles continue to impact unsaleable returned goods in the healthcare supply chain, as reported by the HDMA Returns Task Force (RTF) in a white paper published in January 2007. Industry members say efforts being made to improve processes and technology efficiencies for returned unsaleable healthcare products, such as leveraging technology to streamline data flow between trading partners and cutting down time between when a product is received, and when the manufacturer credits the retail pharmacy for it. 

Stericycle, which provided resources to aid HDMA in the development and publication of the white paper, says it is working with industry, distributors and other third-party service providers to identify current best practices in the areas of returns, recalls and withdrawals, and reverse logistics. “Stericyclehas established best practices to help manufacturers efficiently manage the reconciliation process, enabling clear and accurate reconciliation, visibility to ‘work-in-progress,’ and the ability to manage count discrepancies in an efficient manner,” Rozembajgier says. 

For example, Stericycle demonstrated its commitment to developing expanded capabilities by launching its Debit Memo Service (DMS) last year. “DMS allows clients to quickly and systematically reconcile 3PL (third party logistics) Debit Memos to actual process data (physical product received) and create the necessary short payment forms, as designated by the wholesaler,” Rozembajgier explains. The result supports shorter debit memo processing time and enables potential re-allocation of resources. “In the DMS pilot study, Stericycle enabled a manufacturing client to reduce internal overhead by 3 FTEs (full time employees),” he says. 

Some 3PLs are leveraging their large retail and wholesale scale to drive costs out of the returns process for both trading partners. One potential solution offered in the HDMA report is adopting a one-count arrangement, referring to a drug return process that would reduce multiple handling and system redundancy, thus driving costs from the supply chain. By comparison, the traditional two-count returns process results in multiple entities touching the product, each one adding cost. 

“While some predict that the one-count process is not likely in the near future, Inmar CLS MedTurn has already made it a reality with a program called the “One Touch Advantage,” Ashley Kermann, product manager at Inmar CLS Medturn, says. 

By servicing a large share of the wholesalers and retailers in the healthcare industry, Inmar CLS MedTurn touches the returned product first. “Many of our manufacturers, in collaboration with their trading partners, have made the innovative leap of agreeing to a one-count process and eliminating transportation costs, sharing destruction costs and receiving more real time data feeds for faster credit reconciliation purposes,” Kermann says. “This approach not only provides financial benefits, but also is an environmental sustainability best practice by eliminating a leg in the transportation and reducing carbon footprint which creates value for both retailers and manufacturers.” Eliminating touch points also alleviates the risk associated with shrink and counterfeit. 

One Touch Advantage is supported by highly automated systems that provide the documentation and quality assurance necessary to meet government regulatory requirements, Kermann says. “Most decisions are computer aided to drive accurate decisions regarding the proper waste stream at the lowest level of detail - the item level.”

	With ever-changing regulatory requirements for product disposition and recall management, not to mention growing concern regarding counterfeit and diverted product, a pharmaceutical returns program must incorporate policies and programs that control the risk associated with these governmental and environmental changes. Which is a big reason, experts say, why reverse distributors are reporting notable increases in the number of drug companies utilizing their services. An increase of more than 200% utilization of core services to assist manufacturers in supply chain related activities “is testimony that Guaranteed Returns has viable solutions for the manufacturers as well,” Schaltenbrand says. 

A competing service is offered by Guaranteed Returns, called the One & Done Program, which is the multi-sourcing of product processing. “This is a trend that has gained traction due to the inefficiencies and multiple handling costs that are encountered in the supply chain,” Schaltenbrand explains. “Guaranteed Returns has been successful in setting up over 70 trade partner agreements with manufacturers allowing Guaranteed Returns to destroy the product at station and electronically report processing data (EDI 180) to the trade partners, thus eliminating shipping costs and duplicate processing costs at either the manufacturer or its return goods agent expense.” 

Indeed, companies specializing in handling drug product returns and recalls concur they are well positioned to handle every aspect of reverse logistics, including notification and response, processing and tracking, compliance and reporting. They offer various turnkey solutions which can be customized to handle recalls of any size and scope. 

“We believe we can enable the elimination of non-value added activities, thus driving out unnecessary costs,” Rozembajgier says, adding that Stericycle partners with approximately 200 pharma manufacturers to deliver total supply chain visibility and robust, independent data that drive common objectives. “Stericycle’s investments in quality and technology have resulted in meaningful business improvements and significant savings for our customers.” PC 

Sustainability initiatives add to the complexity of managing reverse logistics for life sciences products

Reverse Logistics Service Providers Deal with Safety and Environment

	Diseases of the central nervous system (CNS) have been a treatment target of the biopharma industry for decades, with waves of new products or treatment pathways appearing each decade or so. The urgency comes from the dire situation that patients and their families find themselves in, with debilitating illness and suicide being the endpoints of two of the most common mental illnesses: depression and psychosis (primarily schizophrenia or bipolar disorder).

The successful development of medication for these diseases (other CNS conditions, including memory, sleep and pain management, won’t be treated here) have created business opportunity for biopharma, such that today, anitpsychotics are the highest-value therapeutic class (see table), and antidepressants one of the fastest-growing. But with the opportunity comes risk: Penalties for improper, off-label promotion have been in the hundreds of millions of dollars (with Lilly and its antipsychotic, Zyprexa, receiving the highest DoJ penalty ever—for $1.42 billion&mdash;at the beginning of this year). Thousands of lawsuits have been filed by plantiffs claiming damages for many CNS drugs over their side effects. And the relationship between the biopharma industry and mental health professionals is a charged one: the American Psychiatry Assn. is one of the first medical societies to ban nearly all types of sponsored interaction between the industry and the profession (which is all the more ironic in that more education for healthcare providers is a nearly constant refrain for improved care). 

Part 1 of this report will look at the current industry product offerings and prospects, and the evolving treatment paradigms. Part II, to be published in the next issue, will look at regulatory challenges in marketing and distribution, and the impact of comparative effectiveness studies. 

	Antipsychotic and antidepressant drugs—like the conditions they treat&mdash;live under a cloud. Because schizophrenia, bipolar disorder and depression are often underdiagnosed, mental health professionals constantly fight to get society to acknowledge the real harm or debilitation that the conditions cause. For the medications themselves, there is widespread debate over the risks and benefits of the drugs. Off-label use is high (and highly controversial), with some patients and their families desperate for relief, and others accusing the industry of over-promoting the drugs’ value. The fact that considerable consumption occurs among the elderly (including those with various forms of dementia) and the young adds intensity to the debate.

Perhaps the most indicative sign of what’s at stake is that, sadly, one of the measures of antipsychotic and antidepressant drug efficacy is preventing suicide or suicidal ideation. 

The notion that individuals afflicted with various forms of debilitating psychiatric illnesses can “pop a pill” provides a desperately needed lifeline for patients and their families, but this mindset tends to downplay the risk of serious side effects and potential health consequences that all antipsychotics and antidepressants carry. As a result, it’s been anything but smooth sailing for brand managers and marketing teams in charge of these drug franchises, and in recent years wave after wave of market-shaping events have rocked the industry. 

These include unfavorable results emerging from several head-to-head comparisons of the leading antipsychotics (findings that have challenged many of the widespread assumptions about these drugs), the increasing prevalence of Black Box warnings required for drugs in both groups (sidebar), regulatory litigation and heavy penalties, and heated competition among manufacturers, along with the familiar impact of patent expiry.

	Off-label use brings its own controversy Antidepressants and antipsychotics are being dispensed to treat children with behavioral problems and attention deficit disorders, and older adults with dementia related psychoses. But patient advocates and mental health professionals question the practice. For instance, while many physicians argue that suitable alternatives are simply not available to treat the symptoms of mental illness and depression in children and seniors, a growing body of research has brought into question the safety, cost and effectiveness of many of today’s leading antipsychotics and antidepressants in these vulnerable patient sub-populations. 

Among these two drug classes, the list of life-threatening side effects includes increased risk of suicide and premature death, weight gain so significant that it statistically increases the risk of heart disease, diabetes, lipid abnormalities and other metabolic disorders, and more. These potential side effects are compounded by the fact that individuals with schizophrenia and other forms of mental illness tend to have a higher risk of diabetes than the general public (due, primarily to lifestyle issues such as a sedentary lifestyle, poor diet, lack of proper medical care, and a high rate of obesity), and those with with moderate to severe depression, if left untreated, already face a higher risk of suicide, as well. 

All of these events provide a tense backdrop for brand managers, who are seeking to position their psychoactive drugs as safer and more efficacious than those of their rivals.

	Within the realm of antipsychotics, the medications available for use today are classified as typical (first generation) or atypical (second generation) antipsychotics. The older typical antipsychotics include Compazine (prochloroperazine), Haldol (haloperidol), Loxitane (loxapine) Thorazine (chloropromazine) and others, most of which are now available in generic form. 

The newer atypical antipsychotics include Abilify (ariprazole), Clozaril (clozapine), Geodon (ziprasidone), Invega (paliperidone), Risperal (risperidone), Seroquel (quetiapine), Zyprexa (olanzapine) and Symbyax (olanzapine and fluoxetine), some of which are available as generics. 

Both classes are composed primarily of dopamine receptor antagonists, which work by blocking the action of naturally occurring dopamine in the brain. They differ primarily in their side effects, with the newer atypicals tending to have a lower incidence of neurological side effects such as involuntary movements, tics and Parkinson-like shakes, as well as undesirable cognitive effects that plague many of the older conventional antipsychotics. 

In 2008, the therapeutic class of antipsychotic drugs ranked #1 in US sales (having moved up from the rank of #3 the year before), according to IMS Health, totaling $14.4 billion in 2008, up from $9.5 billion in 2004. In 2008, nearly 53 million prescriptions for antipsychotics were written in the U.S., up from nearly 44 million in 2004.

Meanwhile, with sales of $11.4 billion in the U.S. alone, the antidepressants ranked #5 among the top 15 therapeutic classes in 2008. While the 2008 dollar sales figure was down from an earlier high of $13.1 billion in 2004, this indicates growing demand for less-expensive generic antidepressants — not shrinking overall use, according to IMS. For instance, during the same time period (2004-2008), total U.S. prescriptions for antidepressants rose from 182 million in 2004, to 207 million in 2008, helping the antidepressants to become the third most widely dispensed prescription medications, on a volume basis, in 2008. 

Similarly, the 15 top-selling drugs in 2008, by U.S. sales, according to IMS, included two antipsychotics and two antidepressants: 

• The antipsychotic Seroquel (quetiapine) from AstraZeneca (#5 on the list), nearly doubled its sales over the last five years, recording 2008 sales of $3.9 billion, up from $2.1 billion in 2004

		• The antipsychotic Abilify (aripiprazole) from BristolMyers-Squibb/Otsuka (#12), nearly tripled its sales over that same time period ($3.1 billion last year, up from $1.0 billion in 2004)

		• The antidepressant Effexor XR (venlafaxine HCl) from Wyeth (#14) enjoyed 2008 sales of $3.0 billion, up from $2.6 billion in 2004

		• The antidepressant Lexapro (escitalopram oxalate) from Forest (#15), saw its sales rise from $1.8 billion in 2004 to $2.7 billion last year.

	The symptoms associated with schizophrenia and other forms of mental illness — ranging from delusional thinking, thought disorder, and hallucinations, to social withdrawal, apathy and reduced ability to express emotion &mdash; exact a heavy toll not only on the afflicted, but on society, as well. 

Direct costs associated with mental illness arise from increased medication use, clinic visits and hospitalization, lost earning potential, costs associated with Social Security disability payments, homelessness and incarceration, and more. According to an NIMH study published May 7, 2008, in the American Journal of Psychiatry, major mental disorders cost the U.S. at least $193 billion/year in lost earnings alone. “This estimate is probably conservative because [the study] did not assess people in hospitals or prisons, and included very few participants with autism, schizophrenia or other chronic illnesses that are known to greatly affect a person’s ability to work. The actual costs are probably higher than what we have estimated,” said Ronald Kessler, PhD, of Harvard University, author of the study. 

Nearly one in four US adults suffer from a diagnosable mental disorder in any given year, and mental disorders are the leading cause of disability for people aged 18-44 

Major depressive order is a leading cause of disability in the U.S. for ages 15-44, affecting roughly 14.8 million American adults (6.7% of U.S. adults aged 18 and older) 

Bipolar disorder affects roughly 5.7 million American adults (2.6% of U.S. adults)

		Schizophrenia affects 2.4 million American adults (1.1% of U.S. adults)

Anxiety disorders — including panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder and phobias &mdash; affect roughly 40 million American adults (18% of U.S. adults)

NIMH statistics indicate that depression is responsible for up to 70% of psychiatric hospitalizations and 40% of suicides. Currently the fourth most disabling illness worldwide, depression will be the second leading cause of disability by the year 2020, according to the World Health Organization. 

The cost of depression in the U.S. in the year 2000 was estimated to be $83 billion, including both $26 billion in costs of treatment and $57 billion in losses related to absenteeism, reduced productivity at work, and earnings lost due to suicide-related deaths, according to NIMH. 

With an overall rate of 10.9 suicide deaths per 100,000 people, suicide is considered to be a major, preventable public health problem. According to NIMH, in 2004 suicide was the eleventh leading cause of deaths in the U.S., accounting for 32,439 deaths. 

	Much of the growth in antidepressant and antipsychotic use in recent years can be attributed to a shift in the domain of prescribers who now freely prescribe both classes of psychiatric drugs. “I can tell you from my own clinical practice that this has completely changed since I completed my geriatric fellowship in 1993,” says Richard Stefanacci, DO, MGH, MBA, AGSF, CMD, Director, Institute for Geriatric Studies, Mayes College for Healthcare Business & Policy, University of the Sciences in Philadelphia. “At that time, these powerful psychotropic drugs were prescribed exclusively by psychiatric and neurological specialists, but this is no longer the case today.” 

Views on the impact of this evolving prescriber domain are mixed. Advocacy groups argue that it invites potential problems, because it is helping to drive the “drug-centered treatment paradigm” that prevails today for many psychiatric conditions — whereby doctors and insurers overemphasize the use of prescription drugs as quick-fix solutions, while underemphasizing difficult, more-costly and more-time-consuming psychiatric intervention such as talk therapy and other forms of psychotherapy and occupational therapy. 

Others argue that many of today’s primary-care physicians (PCPs) are not adequately trained to properly diagnose, prescribe and manage patients with psychiatric problems. “Today, many PCPs feel so comfortable with these medications that they call in verbal orders without even seeing the patient,” says Stefanacci. “Unfortunately, many PCPs have the perception that these medications are completely safe — which is ironic, given that they carry a Black Box warning.” 

Expanding the prescriber base certainly puts the onus on the drug manufacturers to provide greater educational-outreach efforts that are geared toward non-specialty physicians. “The message and delivery of pharma outreach needs to be completely different for PCPs,” says Stefanacci. 

Others argue that this paradigm shift is a good thing, because the broader base of prescribers casts a wider net to intervene on behalf of patients who might benefit from the use of an antidepressant or antipsychotic but are not likely to seek help from a psychiatrist. For instance, according to NIMH, research shows that many people who commit suicide are likely to have seen their physician in the year prior to their death; thus, improving the ability of PCPs to recognize and treat risk factors has been identified as one major way to help prevent suicide among these groups. 

Similarly, in the April 2009 issue of Pediatrics, the United States Preventive Services Task Force, an independent, government-appointed medical panel that sets public health guidance for doctors on a variety of health-related issues, began urging doctors to perform routine screening on all American teenagers for depression. Today, an estimated 6% of American teenagers — nearly two million teenagers &mdash; are clinically depressed (a problem that can lead to persistent sadness, social isolation, problems in school and even suicide), and most are undiagnosed and untreated, according to the group. Evidence shows that detailed but simple questionnaires can accurately diagnose depression in the primary-care setting such as the pediatrician’ or primary-care physician’s office.

 article, the panel stressed that it did not want its advice to lead to drug treatment alone, but should include psychotherapy, as well, particularly because some antidepressants have been linked to increase risks for suicidal thoughts. Meanwhile, because psychiatrists specializing in treating children and teens are scarce, a separate report (published in the same issue) notes that PCPs (including pediatricians and family physicians) will need to get more deeply involved in mental health care to carry out these latest recommendations. 

“The willingness of PCPs (including internists, family physicians and geriatricians) to prescribe these medications is a healthy development overall, because it is helping more people to be properly screened and to begin treatment,” says Barney Spivack, MD, Medical Director of LifeCare (Shelton, CT). Spivack is a member of the American Medical Directors Assn. (AMDA; Columbia, MD), the national association representing more than 8,000 medical directors, attending physicians and others who practice in nursing homes and other long-term care (LTC) facilities, and currently serves on its clinical practice committee. 

Managing depression is also an issue of interest for many employers and unions, because it has a big impact on worker productivity, says benefits consultant F. Randy Vogenberg, RPh, PhD, Principal for the benefits and training consultancy Institute for Integrated Healthcare (IIH; Sharon, MA). “When they are able to more effectively screen employees with mild to moderate depression, to make them more happy and productive workers, it’s a win-win for everybody.” 

He notes that a growing number of the health and wellness initiatives being offered by employers and unions now include screening for depression. Drug companies can get involved here, by developing unbranded, education-oriented partnerships with employers and unions. 

Meanwhile, because PCPs and other medical specialists “tend to see a high prevalence of anxiety and/or depression in people being treated for chronic medical illnesses, these physicians are in a good position to help patients to manage these issues,” says Peter Winn, MD, CMD (Okahoma City, OK), who is board-certified in family medicine and geriatrics. Winn is a Medical Director for a long-term-care facility and hospice, and is a member of the AMDA Board of Directors. 

The expansion of the prescriber domain has other advantages, as well. For instance, Vogenberg notes that “insurance often limits the number of visits a patient may make to a psychiatrist, so it’s common for psychiatrists to initiate prescriptions of antidepressants and antipsychotics but then refer the patient to his or her PCP to continue therapy and ongoing monitoring.” 

This shift is especially apparent in long-term care facilities, nursing homes and assisted-living facilities, “where geriatric psychiatrists tend to be few and far between,” says Spivack. “It’s often the nurses (including advance practice nurses, APRNs) and other members of the interdisciplinary care team who have the closest contact with the residents, and are thus in the best position to evaluate and recommend condition-specific treatment, and these individuals often direct, drug-related recommendations to the attending physicians, prompting them to act on the described symptoms,” adds medical director Winn. 

	“The fact that the bulk of the treatment can be appropriately instituted by PCPs today is an excellent development, but drug companies need to do everything they can to reinforce the idea of using antidepressants and antipsychotics appropriately,” says Spivack. “Too often, physicians jump around and switch medications before appropriate doses or recommended duration of treatment even reached. It should be incumbent on PCPs to have a good working knowledge of these complex medications.” 

Given the many parallel issues that are at play in both drug classes, industry observers agree that it’s in the brand team’s best interest to develop meaningful, educational outreach — rather than heavy-handed product promotion &mdash; to support the most responsible prescribing (both approved and off-label) by both generalist physicians and specialists in the field of psychiatry. 

“To support all of these clinicians, drug makers should develop good, creative, interactive programming that can help them to recommend the right drug for the right patient at the right dosage, and enhance their own ability to better manage mood and behavior problems among the elderly,” adds Spivack. 

“Drug companies should be more proactive about publishing evidence-based studies, articles and critical evaluations not just in medical journals aimed at generalists and family physicians, but in practitioner journals aimed at nurses and mid-level practitioners such as nurse practitioners (NPs) and physician assistants (PAs),” says Winn of AMDA. 

He also notes that “pharma sales reps need to be forthright with prescribers during detailing efforts — for instance, including balanced information from studies and/or editorials, especially those that challenge the results of drug studies as to the general applicability to certain patient populations such as older adults and those in long-term care settings.” 

Specifically, experts suggest that educational outreach efforts aimed at general physicians should help them to: 

Recognize symptoms and diagnose problems related to depression, schizophrenia and bipolar disorder and other forms of mental illness 

Evaluate and prescribe the most appropriate initial treatment options (to match patients with the most appropriate drug options), and to understand the evidence-based protocols for moving patients through successive treatment options in each drug class 

Carry out appropriate ongoing monitoring to track metabolic and extrapyramidal side effects (such as movement disorders including tardive dyskinesia and dystonia) 

Know when to refer the patient to a psychiatric specialist.

Similarly, Stefanacci points out that outreach aimed at psychiatrists and other mental health experts should provide evidence-based research that can help them to manage difficult cases, where, for instance, the patient may need to move through a succession of alternative drugs in response to issues related to tolerability, efficacy or side effects. Unbranded outreach should also encourage psychiatrists to develop and maintain relationship with the PCPs of their patients, so they can support the patient with appropriate prescription refills, ongoing adherence and monitoring efforts, once the psychiatrist has been referred the patient back to his or her doctor for long-term treatment management. This is especially important considering the need for ongoing bloodwork and monitoring that is required when using these potent psychotropic drugs (discussed below). 

Antipsychotic and antidepressant drugs have risen to the top categories of prescribed medications in a challenging and risky medical and regulatory arena

Surveying the Mental Health Medication Landscape - Part 1

	In a co-development project, GSK’s Lamictal (lamotrigine) has been reformulated as an orally disintegrating tablet using the Advatab and Microcaps technologies of Eurand NV (Milan; US HQ: Vandalia, OH). Lamictal is currently a $1.3-billion product in the US, and is prescribed primarily for the longterm treatment of bipolar disorder and a variety of seizure disorders. The ODT version, together with Eurand’s taste-masking encapsulation technology, called Microcaps, is expected to make the drug more available to patients with difficulty swallowing.

“Patients with epilepsy or bipolar disorder can have difficulty swallowing tablets. Unfortunately, this problem may go unrecognized, because many patients don’t discuss this issue with their healthcare providers,” said Daniel Lieberman, MD, associate professor and clinical director of the George Washington University Dept. of Psychiatry and Behavioral Sciences, in a statement released by GSK. “Orally disintegrating tablets, like Lamictal ODT, offer an option for patients who have difficulty swallowing tablets.” 

Under terms of the agreement, Eurand will manufacture Lamictal ODT exclusively, and may have certain rights to commercialize it outside the US. Eurand will receive an undisclosed milestone payment upon launch, revenue for manufacturing Lamictal ODT tablets for GSK, royalties on net sales of the product and milestone payments in connection with Lamictal ODT achieving predetermined sales levels in the U.S. marketplace. 

	Eurand’s proprietary Advatab technology employs granulation and tabletting technology to produce the ODT form, which can be taken by the patient with our without water. The Microcaps encapsulation technology coats drug particles to mask the drug’s taste while allowing it to dissolves in the stomach. 

“We were delighted to have the opportunity to use our AdvaTab(R) and Microcaps(R) proprietary technologies to co-develop Lamictal ODT with GSK, and we look forward to a successful launch,” said Gearoid Faherty, Chairman and CEO. “We see Lamictal ODT, Eurand’s fifth FDA-approved drug since 2001, as another clear demonstration of the breadth of our drug formulation expertise and the depth of our pipeline.” PC 

FDA approves new formulation based on bioequivalency with existing product

Eurand Scores With Orally-Disintegrating Form Of GSK's Lamictal

	Claiming that more than half of all metered-dose inhalers (MDIs) deploy 3M technology, the St. Paul, MN, company is extending its product line with two new designs: the Taper and Conix Dry Powder Inhalers. The Taper unit (Fig. 1), recently introduced at a Respiratory Drug Delivery conference in Lisbon, Portugal, stores API on a “dimpled,” microstructured carrier tape. Up to 120 metered doses, each up to 1 mg of API, are embedded on the carrier tape. When a patient inhales through the device, the patient’s airflow activates an impactor that releases the dose from the tape. 3M says that the carrier tape structure obviates the need for lactose or other excipient powders to sustain product release, thus allowing the tape to carry API only on its surface.

The Conix design (Fig. 2) incorporates a reverse-flow cyclone to control airflow. The patient’s breath activates the movement of powder to the patient, while controlling the effects of moisture. The design is currently available for such applications as mass immunizations or vaccinations, and treatment of asthma, COPD or hay fever. 

“We are the leader in MDI delivery systems and now we’re advancing full-steam into DPI drug delivery with several significant offerings,” says Jim Vaughan, division VP, 3M Drug Delivery Systems. 

	For inhaler applications where a pressurized spray is desired, 3M has recently developed two innovations: a plasma-based coating for the pressurized canister (Fig. 3), and a face-seal valve that simplifies dose delivery. (“Plasma” is an ionized stream of atoms; the industrial process is a way of coating surfaces with desired chemical attributes.) The plasma coating, which can be applied to metal or plastic containers, is especially useful for APIs that degrade when in contact with metal oxides. The coating can also minimize deposition on the container surface. 

The face seal innovation eliminates the need to prime an inhaler by collecting the dose as the inhaler is fired. According to 3M, traditional pMDI valves operate on a “dose retention” principle, collecting the dose when the valve stem is released after firing. Over time, this can lead to loss of prime or loss of dose, which is why patients are advised to prime these inhalers by firing an uninhaled shot before use. The 3M Face Seal Valve eliminates the need for this extra step, simplifying the process for patients and making compliance easier. PC 

Carrier tapes deliver precise dosages that can be pure API; canister technology improves pressurized dose delivery

3M Drug Delivery Expands Inhaler Options

	Continental Airlines Cargo has made a “selection” of the AcuTemp RKN container for use on its cargo jets, says CSafe LLC (Dayton, OH) in a recent announcement. CSafe is the marketing j.v. between AcuTemp Thermal Systems (Dayton, OH) and AmSafe, Inc. (Phoenix), the two companies that developed the RKN unit. “Our selection by Continental reinforces CSafe’s position as a premier player in the active temperature marketplace and expands customers’ options for temperature critical transportation,” said Steve Boyd, CSafe director of business development.

But the real story here might be Continental’s aggressive positioning to capture more of the cold chain market. Last fall, Continental became the first cargo air carrier to be qualified internationally under a “Qualified Envirotainer Provider Training” (QEP) program run by Envirotainer (Lagga Marma, Sweden), which happens to be the only 

. “Continental is determined to offer our customers the most advanced cold-chain technology available,” said Mark Mohr, Continental’s manager, product development and specialty sales. “The AcuTemp RKN represents the latest addition to our ever-growing arsenal of temperature-sensitive shipping capabilities.” 

Envirotainer’s and CSafe’s containers are unit-load devices that contain a pallet-sized (more or less) shipment of pharmaceuticals. Both can be “active,” meaning that they have onboard refrigerators (or, if necessary, heaters) that can be powered from batteries or plugged in. (Similar “passive” devices use dry ice or refrigerated phase-change material to maintain temperature). CSafe’s unit is FAA-rated; Envirotainer’s, although on the market longer, await FAA approval. PC 

AcuTemp remains the only FAA-approved container for domestic US use

Continental Cargo Approves Use Of AcuTemp Active-Refrigeration Container for Cold Chain Shipping

	A COLLABORATIVE EFFORT among the American Pharmacists Assn. Foundation (APhA Foundation; Washington, DC), a couple dozen employer-based health plans, and with financial support from GlaxoSmithKline, called the Diabetes Ten City Challenge (DTCC), was initiated during 2005. The goal was to evaluate the medical and economic benefits of active intervention in patient care, in the form of patient coaching by pharmacists. Final economic and clinical results have just been published in the J. of APhA (May/June; 2009;49:e52-60).

“It’s well known that diabetes is a national public health issue, with one of every five healthcare dollars being spent on it,” says William Ellis, executive director of the APhA Foundation and a coauthor of the study. “DTCC shows that intervention results in improved patient health and lower overall insurance costs, and that the model of using pharmacists as coaches can work on a broad basis.” The study comprised 573 patients, in ten cities nationally, whose employer-based plans agreed to cover the costs of medication co-pays and of interventions, over a two-year period ending in December 2007 (overall data were normalized for one year for each individual patient).

Statistically significant improvements were seen in glycosylated hemoglobin, cholesterol and blood pressure—all relevant to diabetes care, along with better vision testing and foot examination patterns. Factoring in the extra costs (of the coaching and other interventions, and of greater medication use), and comparing patient health costs to a projected level based on actual medical claims plus inflation, the study showed an overall savings of $1,079, or 7.4%, per patient, despite medication costs rising 32% over what had been projected. (Measurements of actual pharmaceutical consumption are not part of what APhA reported in the published study.) 

	“Larger-scale tests like these demonstrate the value of medication in managing chronic disease, which is a message that needs to be heard in Washington as well as in the healthcare system,” says Andy Hartsfield, VP of public policy and advocacy at GSK. He says that the scale-up of the program (which traces back to the Asheville Project of the 1990s) gives it national relevance. GSK is going on to set up a similar program just for the city of New Orleans (which was to have been in the study, but the Katrina hurricane disrupted that). APhA Foundation, meanwhile, is looking to conduct a similar study for depression patients. PC 

Medical and economic results from Diabetes Ten City Challenge show significant benefits in patient health, lower healthcare costs—and higher pharmaceutical usage

'Ten Cities Challenge' Diabetes Education Program Publishes Positive Results

	Just after she was accepted as secretary of HHS by Congress, Kathleen Sebelius was sent a letter from two groups representing a wide swath of diagnostics technology developers and patient advocates (108 in all). The letter petitions Sebelius to move ahead on developing a regulatory framework that would in effect validate genetic and other “advanced diagnostic testing” methods for healthcare providers.

According to the two groups, the Genetics and Public Policy Center and the Coalition for 21st Century Medicine, there are already more than 1,500 genetic and other tests in use by healthcare providers to analyze the interaction of patients and drugs. In 2007, then-secretary Mike Leavitt charged an advisory committee to make recommendations on a framework, but there has been no further action on its recommendations. 

Industry sources indicate that there is little consensus on the value of the tests, and that quality of testing performed, and the relevance of the results obtained, vary significantly. The potential of personalized medicine rides on using these tests, and getting the testing in turns rides on the willingness of CMS and private payers to support them. 

Among other things, the groups seek an oversight and rulemaking process from FDA, setting up a registry for laboratories, and validating their practices through the existing HHS Clinical Laboratory Improvement Amendments (CLIA) program.

Personalized medicine is still more a potential than a reality

Advocates of Diagnostic Testing for Personalized Medicine Press HHS for a Regulatory Framework

	Smith Drug Co. (Spartanburg, SC) opened its Valdosta facility in May, representing a capital investment of $15 million, according to the company. The facility has a 109,000-sq-ft footprint, will employ up to 40, and is said to employ the latest distribution and software technologies.

“Our business is about serving independent pharmacies in the Southeastern region. With the additional distribution center in Valdosta, we will be able to specifically support those pharmacies in the Georgia and growth-oriented Florida market,” says Ken Couch, president.

Smith Drug’s other distribution centers are in Paragould, AR, and Spartanburg. PC 

New Valdosta, GA, facility is targeted at independent pharmacies in the Southeast

Smith Drug Co. Opens a Third Distribution Center

	Now in its fifth year as organized by Fuld & Co. (Cambridge MA), a type of competitive analysis known as war-gaming identified McKesson as a potential winner when the business environment for EMRs becomes established. Fuld & Co. sets up teams from leading business schools (this year, MIT [Sloan], UPenn [Wharton], Columbia, and Northwestern [Kellogg]), each representing one candidate EMR player: Microsoft, McKesson, Kaiser-Permanente and Allscripts. Fuld & Co. scripts likely scenarios and—in real time&mdash;the b-school students develop strategies and make presentations to a board of judges, who choose the ultimate winner.

“McKesson will work to vastly expand its healthcare IT niche through its dominance in logistics and understanding of the health value chain, data creation and data utility—with an emphasis on physician, payor and healthcare delivery applications” concluded the Fuld report of the exercise. 

“Clearly, EMR is in its infancy,” says Leon Fuld, president, “but the eventual impact of the technology on the bipharma industry is broad and inevitable. Players in the healthcare arena will gain total transparency on issues like evidence-based medicine and comparative effectiveness. This will impact both drugs on the market and clinical research.”

	And the fact that the No. 1 drug wholesaler could become the No. 1 EMR system vendor generates many potential implications of its own.

War-gaming analyst picks the drug distributor over Microsoft, Allscripts and other EMR players

The Shape of the Electronic Medical Record Market

	Cegedim Dendrite (Bedminster, NJ) is one of several firms now offering a service that tracks the proliferation of state-level rules on reporting gifts, sponsorships or other marketing activities that occur between manufacturers and healthcare providers. A chart from Cegedim Dendrite’s reporting service shows the growing complexity of this activity (see also 

The Pharmaceutical Research and Manufacturers Assn (PhRMA; Washington, DC) sought to forestall state activities like these with its voluntary marketing guidelines, the “Code on Interactions with Health Care Professionals.” For signatories to that code, the use of non-educational items like pens and coffee cups is now prohibited. As of February, according to PhRMA, 40 companies (including some non-PhRMA members) have signed the code—but it is not obligatory among even PhRMA members. Around then, the Biotechnology Industry Assn. (BIO, Washington, DC) adopted a similar measure. 

Obviously, the industry codes have not satisfied state legislators who are writing more rules. Some states require item-by-item reporting, and some only want cumulative spending; some include medical devices and some do not. The expense of managing the various programs and their reporting requirements is represents another burden on the industry that Cegedim Dendrite and others are trying to address. 

States pile on rules; industry wishes for consistency

Pharma Gift, Marketing and Advertising Reporting Rules Multiply

	It’s highly ironic that after all the effort going into launching a product, energizing a sales force and informing the general public, many pharma companies pay too little attention to how the sales contracts by which the products are sold get written and administered. And while an IT company like Model N (San Ramon, CA) which sponsors an annual survey on the subject (with CSC, the IT services firm) has an obvious benefit in highlighting shortcomings here, it is reporting data from the contract administrators themselves. And they are worried.

The 2009 survey (highlighted at the Commercial Contract and Chargebacks meeting of CBI, June 23-24, Philadelphia) noted that there are more contracts, and more complexity, than ever: the median number of contracts is 100, and 35% of respondents expect complexity to increase in contracts with government, MCOs and retailers. Essentially all of the respondents (from more than 70 biopharma companies) said they experienced some revenue leakage; with losses ranging between 2 and as much as 26% of contract value. Errant chargebacks, unapproved pricing, errors in calculating incentives, and discounts to ineligible parties are among the causes. Even so, a third of companies track contract compliance less than once a year, and 35% of companies monitor compliance on fewer than half of their contracts. 

About a third of respondents use manual processes or spreadsheets to monitor contract performance; a third use their ERP system or a custom revenue-management system. Model N says that 23% of respondents use a packaged revenue-management system comparable to what it offers. That points to a significant unmet need in the marketplace, which Model N and others will hope to take advantage of. 

Model N’s annual analysis of commercial operations finds lost revenue and a lack of IT tools

Contract administration is still 'mediocre to weak' among the majority of biopharma companies, says survey

	A direct-to-consumer targeting and media guidance service called Smart has been announced by marketing consultancy Copernicus in Waltham, MA. Separately, promotions response solutions intended to optimize marketing budgets have been unveiled by healthcare analytics provider SDI (Plymouth Meeting, PA). The offerings are well timed: DTC advertising dropped 8% in 2008 after a 4% drop in 2007, as tracked by SDI.

Smart from Copernicus provides a “right-sized” version of a marketing strategy engagement, according to a company announcement. The service provides DTC marketers with what it calls the three essentials elements of a high-performance marketing strategy: A target representing the biggest DTC-driven profit opportunity for a brand; a media budget size and media strategy diagnostics; and a media plan based on syndicated databases. 

Senior VP Eric Paquette says it doesn't make sense for drugmakers to invest in media if the market dynamics aren’t right for their brand. Spending more on DTC advertising historically hasn't done much to improve the performance of ad campaigns, he says, unless equal effort is spent on determining “which patients have the highest potential value to a brand and how to reach them with media first,” according to the announcement.

	Smart requires a 30- to 60-day timeframe for results and is available for “a price that fits a modest research budget,” the announcement says. 

SDI reports that promotional spending has tapered off, largely the result of the shrinking pool of blockbusters. Total promotional expenditures increased just 1% in 2008, as tracked by SDI, which includes the 8% drop in DTC expenditures; spending has grown an average of 2% annually from 2004 to 2008. 

SDI’s HIPPA-compliant promotion response solutions target marketers’ need to show return on investment for promotional campaigns targeting patient/consumers and prescribers. It leverages the company’s de-identified longitudinal patient data sets, which comprise more than 100 sources and 200 million patients. Data sources include pharmacies, pharmacy benefit managers, and payers. 

Metrics include acquisition, conversion, retention, and prescribing behavior following campaigns, with analyses delivered in about 10 days, according to the company. 

As direct-to-consumer advertising declines, vendors offer tactical aids to marketers

More tools for evaluating DTC advertising

	NanoGuardian has struck a deal in which SDI will run the proactive, post-marketing monitoring portion of the Closed-Loop Protection program, an anticounterfeiting initiative of the Skokie, IL-based product-authentication technology company. SDI (Plymouth Meeting, PA) will capitalize on its worldwide clinical and institutional review board connections to select prescribers and retail locations from which drugs will be procured for authentication by NanoGuardian.

 combines on-dose marking for authentication purposes with a proactive pharmacy-auditing program to identify counterfeit or illegally diverted pharmaceuticals in the global supply chain. Authentication is provided by NanoGuardian’s NanoEncryption technology, applied to drugs during manufacture and then used for verification at NanoGuardian facilities after post-marketing sampling. The technology provides both overt and covert security features through use of NanoCodes, which the company says can be associated with product, manufacturing, distribution, and other information.

	The program amounts to an early warning system, allowing manufacturers to detect counterfeit and diverted products, says NanoGuardian, thereby mitigating risk to brands and patients. “To ensure the success of Closed-Loop Protection, it was vital to partner with an organization such as SDI, which has the regulatory experience in conducting proactive market monitoring services and that can manage networks of pharmacies and physicians,” says Dean Hart, EVP at NanoGuardian. 

	In the NanoGuardian deal, SDI will set up networks of physicians who will write prescriptions to be filled at retail pharmacies, to then be picked up by security personnel and sent to NanoGuardian labs to be checked for authenticity. To establish the networks, SDI is extending existing efforts in which the company has developed surveillance systems for diseases using such sources as physician reports and lab and claims information gathered worldwide. “Because of these networks, we are able to access these folks reliably to provide information,” says Laurel Edelman, VP for clinical accounts. By working through IRBs, SDI ensure the medical community that its work is clinically relevant, protocols are established, and information is handled in conformance with HIPAA requirements. 

Different NanoGuardian clients will have different drug brands requiring different surveillance networks. “What’s unique is finding the right participants—finding providers who are prescribing a certain kind of drug, which brings efficiency to the process,” says Edelman. “The networks will be tailored to the locations and sites where the drugs are being utilized. We want to target to get the highest volume in shortest time.” 

First steps for SDI involve developing clinical protocols for IRB review. Doctor recruitment and background checks will follow. 

Supply-chain monitoring program to be run by healthcare-analytics company

Pharmaceutical Commerce - June 2009

Drug Wholesalers and the Generic Price War

Reverse Logistics Service Providers Deal with Safety and Environment

Surveying the Mental Health Medication Landscape - Part 1

Eurand Scores With Orally-Disintegrating Form Of GSK's Lamictal

3M Drug Delivery Expands Inhaler Options

Continental Cargo Approves Use Of AcuTemp Active-Refrigeration Container for Cold Chain Shipping

'Ten Cities Challenge' Diabetes Education Program Publishes Positive Results

Advocates of Diagnostic Testing for Personalized Medicine Press HHS for a Regulatory Framework

Smith Drug Co. Opens a Third Distribution Center

The Shape of the Electronic Medical Record Market

Pharma Gift, Marketing and Advertising Reporting Rules Multiply

Contract administration is still 'mediocre to weak' among the majority of biopharma companies, says survey

More tools for evaluating DTC advertising

NanoGuardian closes loop with SDI for anticounterfeit protection

Drug Wholesalers and the Generic Price War