COVID-19: Pharmaceutical and life sciences companies experience dizzying deregulation by FDA

Erin McCallister Senior Manager, Health Research Institute, PwC US April 03, 2020

In the past few weeks, the FDA has made a dizzying series of deregulatory moves in response to the coronavirus pandemic, including announcing a therapeutics accelerator and a very narrow authorization of the first available therapeutic for COVID-19. The agency, helmed by oncologist Dr. Stephen Hahn, also has published new guidance on other treatments and new manufacturing methods, among myriad other documents.

On March 31, the FDA launched the Coronavirus Treatment Acceleration Program “to use every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.” Under the program, the agency said it would respond within a day to requests from drug developers and provide “ultra-rapid, interactive input” on development plans and protocol review within 24 hours.

The move came just days after the FDA granted an Emergency Use Authorization (EUA) to the Biomedical Advanced Research and Development Authority (BARDA) that would provide physicians access to the first therapeutic for COVID-19: chloroquine/hydroxychloroquine. In a letter to BARDA, the FDA’s chief scientist, Denise Hinton, said that “based upon limited in-vitro and anecdotal clinical data in case series, chloroquine phosphate and hydroxychloroquine sulfate are currently recommended for treatment of hospitalized COVID-19 patients in several countries.”

The agency said it would limit the use of chloroquine to adolescent and older patients who do not have access to a clinical trial, or who are ineligible to participate in one. Additionally, physicians must obtain the therapeutic from the Strategic National Stockpile to reduce supply disruptions to patients who need the drugs for their approved uses: malaria, lupus and rheumatoid arthritis.

FDA has issued five categories of EUAs related to the COVID-19 pandemic, with more than 20 specific products authorized. The categories are:

  • SARS-CoV-2 diagnostic tests (Feb. 4): The initial EUA permitted the use of the Centers for Disease Control and Prevention’s RT-PCR test for SARS-CoV-2, the coronavirus that causes COVID-19, and has since been expanded to authorize laboratory-developed tests to be used before completing FDA review and for states to authorize other laboratories under their jurisdiction to perform tests.
  • Respirators (March 2): The initial EUA permitted the use of non-FDA-approved N95 masks certified by the National Institute for Occupational Safety and Health and has since been expanded to include imported face masks.
  • Ventilators (March 27): Authorized the use of nontraditional ventilators such as anesthesia gas machines and ventilators approved in other countries.
  • Therapeutics (March 28): EUA for chloroquine/hydroxychloroquine.
  • Decontamination systems (March 28): EUA for a specific manufacturer to safely decontaminate used personal protective equipment (PPE) for reuse.

The FDA is also clearing a path for other therapies. The agency also took steps to increase access to and testing of convalescent plasma, which is taken from individuals who have recovered from infection with SARS-CoV-2, providing a source of antibodies against the coronavirus.

In a set of FAQs, the FDA outlined steps clinicians can take to access plasma via emergency investigational new drug application (IND). The agency is also working with the CDC and the National Institutes of Health to develop master protocols that can be used by multiple investigators to coordinate the testing of convalescent plasma.

The FDA has issued FAQs and guidance documents, many in their final form, forgoing the traditional comment period. Among the latest were a March 30 guidance related to non-FDA-approved surgical gowns, gloves and other apparel and FAQs on March 26 to allow 3D printing as a means to produce more PPE and keep up with shortages for critical medical products.

Yet the FDA cautioned that “3D-printed PPE may provide a physical barrier, but [is] unlikely to provide the same fluid barrier and air filtration protection” as FDA-approved medical products.

Other guidance documents, FAQs and memos include:

HRI impact analysis

In response to the COVID-19 outbreak, the FDA shifted into overdrive as the regulatory apparatus produced more guidance documents in the past month than in the previous few years.

An analysis by HRI found that the FDA issued an astounding 30 guidance documents in March, of which nine were released in the past week as a direct response to the outbreak and were related to medical products or supplies. 

The deluge dwarfs previous years in comparison. Just one guidance document was issued in March 2017, which was related to food importation; 10 came out in March 2018, related mainly to nutrition policy; and 20 were released in March 2019, the month before Scott Gottlieb’s departure as FDA commissioner. Those latter documents were related primarily to veterinary medicine inspection and biological development/labeling.

Similarly, an analysis by HRI found that the number of products that have received EUAs in response to COVID-19 have already overtaken the number that received EUA clearance during the Zika outbreak in 2016 and the Ebola crisis in 2014.

As of March 31, the FDA has cleared 25 products/methods via the EUA process, including 20 in vitro diagnostics, three PPE products, one therapeutic and one related to decontamination. For Zika virus, the agency cleared 20 total products; it authorized 16 products for Ebola.

The moves all come as FDA Commissioner Stephen Hahn is just getting settled. After being sworn in to the role in mid-December, Hahn faces an unprecedented situation. He joined the FDA from The University of Texas MD Anderson Cancer Center, where he rose to the position of chief medical executive after joining the academic medical center in 2015. 

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Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Crystal Yednak

Senior Manager, Health Research Institute, PwC US

Erin McCallister

Senior Manager, Health Research Institute, PwC US

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