FDA loosens some DSCSA restrictions for the duration of the Covid-19 emergency

There is a lot of common-sense value in FDA’s guidance, issued on April 30, to loosen some of the requirements that have gone into force since the Drug Supply Chain Security Act (DSCSA) was passed in 2013. That news comes on top of the FDA decision to provide an emergency use authorization (EUA) for remdesivir, the Gilead drug that has shown some efficacy in treated infected patients; the drug was highlighted by Dr. Anthony Fauci of NIH during an Apr. 29 White House briefing. But lurking underneath these announcements is evidence of growing strains in drug supplies.

The FDA DSCSA announcement clears the way for expediting drug deliveries from suppliers to where they are needed by suspending some distributor requirements. “The distribution of a product for emergency medical reasons … is exempted from the definition of a transaction and excluded from the definition of wholesale distribution under the DSCSA,” says the announcement. Translation: Distributors are supposed to be “authorized,” and their shipments recorded as “transactions,” with both being documented by DSCSA rules. Now, these requirements are being suspended for the duration of the public health emergency (which is in place until late July, and will probably be extended). FDA foresees situations where one hospital pharmacy might ship product to another (a restricted practice under DSCSA rules); or where a distributor needs to change its routine practices (such as an instance where a distribution center gets shut down because of an outbreak).

The loosened restrictions apply to EUA drugs (which would include both the newly approved remdesivir and hydroxychloroquine/chloroquine, President Trump’s pet treatment), but also ones “approved by FDA to diagnose, cure, mitigate, treat, or prevent COVID-19,” says the agency, adding, “For the purposes of this guidance, we refer to these products collectively as covered COVID-19 products.” It’s not clear, at least as of this writing, whether FDA will include the many drugs being used to treat patient symptoms currently—some of which are in tightening supply.

Premier, a group purchasing organization for hospitals, posted an announcement, “As COVID-19 Cases Spike, Demand for Drugs Used to Treat Related, Co-Morbid Conditions Also Soars” on April 30. A month earlier, it published a more in-depth look, via survey results, at year-over-year demand to address the pandemic and included a list of such drugs:

The April 30 Premier announcement highlighted amiodarone, a heart arrythmia treatment, with demand up by 66% in year-over-year demand, as well as septic-shock treatments norepinephrine (up 122%) and vasopressin (up 66%). It’s hard to overlook the presence of fentanyl and midazolam on the Premier; Class II and IV (respectively) controlled substances, which brings DEA policies into the picture as well.

Supply chain strain

“For the most part, our data shows supply has been able to keep up with demand for these drugs and we have not seen widespread shortages – but we were very lucky,” says Premier president Michael Alkire. “Drugs such as amiodarone and norepinephrine were problematic even before Covid-19, rolling on and off the FDA drug shortage list for years. Now is the time for the country to act proactively to ensure drugs needed to treat these conditions are available in abundance, and that we don’t incur shortages should demand increase again with a resurgence of disease.”

For its part, the Healthcare Distribution Alliance, the trade association of US drug distributors, sent a letter to the leading pharmacy or professional pharmacist associations on April 27, “to address, and clarify, concerns that have recently emerged tied to wholesaler allocation practices.” Newly appointed HDA president, Chip Davis, explains that allocations go into place even when there is not an FDA-designated shortage of a drug, nor when manufacturers say that their stocks are adequate. “Distributors consider a medicine in short supply when there is not enough product to fulfill customer orders. This is when using allocation programs to manage the demands on inventory becomes necessary for an individual wholesale distributor.”

“Significant inventory demands have been placed on the healthcare system, particularly in Covid-19 hot zones and areas in which infection surges are anticipated,” affirms Davis.

Getting back to the allocation issue, the earlier Premier survey concluded with some stern assessments; “Threats to the drug supply chain are have emerged and are worsening. Action must be taken now to stabilize the drug supply chain. The drug supply chain is not resilient and immediate action is needed to prevent widespread drug shortages in the United States and ensure drugs with the potential to treat Covid-19 are available for patient care.”