To mitigate COVID-19-related drug shortages, the FDA issued new guidance reminding drug and biologic manufacturers of their legal obligations to notify the agency, in advance, of interruptions or the permanent discontinuance in the manufacturing of certain drugs. It also makes some new recommendations in light of the current emergency.
“We recognize that while some supply disruptions and shortages cannot be predicted or prevented, early communication and detailed notifications from manufacturers to the agency play a significant role in decreasing their incidence, impact and duration,” the agency said in releasing the guidance, which took effect immediately.
While the guidance will remain in effect for the duration of the COVID-19 public health emergency, its recommendations are expected to help the FDA more broadly in its efforts to prevent and mitigate shortages beyond COVID-19. Within 60 days following the termination of the public health emergency, the agency intends to revise and replace the new guidance based on comments it receives and its experience implementing the recommendations.
The recommendations go beyond the notification law, which requires six months’ advance notice when possible. For example, after an initial notification of an interruption is submitted, the guidance urges manufacturers to provide updates every two weeks until the shortage has been resolved. The updates should be submitted even if there’s been no change in the status, the FDA said, as they ensure the agency has the most current information.
However, manufacturers should not provide notification about a newly affected product, such as a new strength, in an update even if it’s related to the previously reported interruption. Rather, a separate initial notification should be submitted to ensure the FDA can track the newly affected product appropriately.
The guidance also recommends that even if they don’t anticipate an interruption, manufacturers should notify the agency when they can’t meet demand for specific products because of a sudden, unexpected spike in that demand.
“Though manufacturers are not required to report this type of situation to FDA, reporting under these circumstances provides an important signal to the agency about a potential shortage and allows FDA to take appropriate steps,” according to the guidance.
When assessing whether a meaningful disruption in its supply is likely to occur, a manufacturer should consider whether the impact is “more than negligible” and would affect its ability to fill orders or meet expected demand for its product, the guidance says. The assessment is to be based solely on the reporting manufacturer’s capacity and supply – not on competitors’ capacities or assumed capacities, or what the manufacturer understands about the market demand for the product.
The FDA said it expects manufacturers to notify it before a meaningful disruption in their own supply occurs. The “FDA should not first learn of a supply disruption resulting from an interruption in manufacturing from a purchaser whose order could not be filled by the manufacturer,” the agency said.
Because the FDA doesn’t disclose what it considers “commercial information” in its drug shortage list, it’s difficult to tell how many of the shortages are due to the coronavirus. And while it didn’t indicate how much of an impact COVID-19 has had on U.S. drug supplies, the agency noted that some retail pharmacies have implemented policies to limit the overprescribing and overdispensing of certain drugs so as to preserve the national supply.
“We are also aware that a number of states have taken action to limit the dispensing of certain drugs, including chloroquine and hydroxychloroquine,” the agency said.
In related news, the FDA said it is working with online marketplaces to remove chloroquine products intended for aquarium use, following the death of a man who reportedly took chloroquine used to treat his fish in an attempt to prevent COVID-19.
The agency said a primary concern during the pandemic is the imminent health threat to consumers who may take animal drugs thinking they are interchangeable with approved human drugs. “Chloroquine products sold for aquarium use have not been evaluated by the FDA to determine whether they are safe, effective, properly manufactured and adequately labeled for use in fish – let alone humans,” the FDA said.
Also on the COVID-19 front, the FDA updated a guidance it released a few weeks ago on conducting clinical trials during the pandemic. In its update, the agency added an appendix with frequently asked questions and answers (FAQs).
The FAQs address issues such as submitting protocol amendments, documenting protocol deviations, initiating virtual clinical trial visits for monitoring patients, making changes to ship investigational products directly to patients, and obtaining and documenting informed consent from patients in isolation due to the coronavirus. The appendix will be updated as new questions arise, the FDA said.
Additionally, the Centers for Medicare & Medicaid Services (CMS) announced that it has expanded its Accelerated and Advance Payment Program to a broader group of Medicare Part A providers and Part B suppliers, but only for the duration of the COVID-19 emergency.