FDA granted emergency use authorizations (EUA) for two therapeutic drugs to treat COVID-19 infections for use under specific conditions:
- On March 28, 2020 one was granted for chloroquine phosphate and hydroxychloroquine sulfate
- On May 1, 2020 an emergency use authorization was granted for Remdesivir
The EUA for the chloroquine products includes a waiver of the requirement to comply with CGMPs, on page 5, Section III, Waiver of Certain Requirements:
“Pursuant to Section 564(e)(3) of the Act, with respect to the emergency use of a product for which an authorization under this section is issued, FDA may waive or limit, to the extent appropriate given the circumstances of the emergency, requirements regarding current good manufacturing practice otherwise applicable to the manufacture, processing, packing, or holding of products subject to regulation under this Act, including such requirements established under Section 501. FDA grants that waiver with respect to the products covered by this authorization.”
The EUA for Remdesivir does not include this waiver and I assume this means they must comply with CGMPs. Bowman Cox provides a detailed report in the Pink Sheet.
Perhaps the waiver regarding compliance with GMPs was granted for hydroxychloroquine based on the Bayer donation of product that was made in Pakistan at a site that had never been inspected by FDA (though the Pakistani authorities in 2015 identified serious deficiencies) and a site in India that had not been inspected by FDA.
Katherine Eban reports on the source of this product in an article published by Reuters on April 16, 2020. The granting of a waiver for the Pakistan/India produced product would be troubling, at best. I’m curious if the labeling notes that waiver, or whether the healthcare providers who might administer this product are aware of the waiver. I don’t imagine it does.
In addition, an 89-page whistleblower complaint was filed by the former chief of BARDA (Biomedical Advanced Research and Development Authority) regarding how US funds were spent, particularly with regard to the purchase of hydroxychloroquine. This provides some additional insight into the issuance of the EUA.
Regarding the proposed use of hydroxychloroquine, Dr. Woodcock of FDA seemed to press for an Emergency Use Authorization rather than a Nationwide Expanded Use IND as originally requested.
Page 43 of the complaint provides her reason: “Given the uncertainty about the risks of chloroquine, an EUA would better protect patients by enabling physicians to closely monitor their progress in a hospital setting and treat any side effects of the drug.”
Hospital use of the drug is clearly a more controlled setting than making the drug available outside of a hospital setting and without physician oversight as the expanded use IND would have permitted. Congratulations to her for standing up for patient safety in this case, however, the waiver from complying with CGMPs in manufacture of the drug remains troubling and is not addressed.
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