A group of biotechnology leaders is urging biopharmaceutical companies in an open letter to ensure that the Food and Drug Administration remain independent and that development of new medicines for Covid-19 be free of political influence, while also pointing to the importance of clinical trial diversity and judicious disclosure of data.
The letter, published Thursday, was signed by Biotechnology Innovation Organization Chairman Jeremy Levin, CEO of Ovid Therapeutics; BIO CEO Michelle McMurry-Heath; Paul Hastings, CEO of Nkarta Therapeutics; Ted Love, CEO of Global Blood Therapeutics; Ron Cohen, CEO of Acorda Therapeutics; Rachel King, CEO of GlycoMimetics; John Maraganore, CEO of Alnylam Pharmaceuticals; and Richard Pops, CEO of Alkermes. All of the biotech CEO signatories are current or former members of BIO’s board.
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“These new products will need to be manufactured in large quantities and distributed rapidly to all segments of our society,” the letter read. “Physicians, public health officials, patients and healthy citizens will need to be educated as to their safety, efficacy, and risk/benefit. Their widespread adoption will be based on trust in the integrity of the scientific and public health principles governing their development and approval.”
The signatories urged biopharma companies to ensure that clinical trials were conducted according to best practices to ensure credibility of their data and ethical participation of diverse study populations, while the resulting data should be disclosed at “well-respected” scientific meetings or in peer-reviewed journals. Data should not be disseminated via press release alone, and data released to the press should be “clear and include accurate descriptions of key data points” while stating that the full data will be submitted for peer review.
Regarding the FDA, they wrote that the agency should maintain its independence as the “gold-standard” international regulatory body and be free from external influence, in order to provide assurance to the public. And political considerations should be set aside by both parties. Moreover, use of products should be driven by data, they wrote, noting that different subpopulations would react differently to medicines. They singled out vaccines in particular when they wrote, “The public should be assured that only rigorously considered data will dictate the subsequent use of any product.”
While not referring to them explicitly, the letter’s list of principles coincides with a number of growing concerns surrounding the development of drugs and especially vaccines against Covid-19, as well as criticism that the FDA has fallen under the political influence of the Trump administration in its decisions.
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One of the earliest announcements of data from Moderna, which in May announced early data for its vaccine against SARS-CoV-2, mRNA-1273. However, while shares of the company rallied on the news, many observers pointed out that the data were far too early to draw conclusions.
Last month, experts writing in The New England Journal of Medicine stated that the Phase III clinical trials testing Gilead Sciences’ antiviral drug remdesivir were insufficiently diverse, not reflecting the disproportionate morbidity and death caused by Covid-19 in Black, Latino and Native American populations in the U.S.
More recently, fears have mounted that the FDA has been issuing some emergency use authorizations – particularly the one granted for convalescent plasma – under political pressure, and that it may fast-track a vaccine against the SARS-CoV-2 virus under similar pressure.
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