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Product Development

BIO leaders urge industry to hew to norms for COVID-19 candidates

Biotech KOLs warn public trust is on the line

Sep 3, 2020 | 10:03 AM GMT

Against a backdrop of questions about FDA’s independence, eight past and present members of BIO’s leadership team have written an open letter calling on industry to hold fast to its principles.

The letter, released Thursday, was signed by BIO President and CEO Michelle McMurry-Heath, Chair Jeremy Levin, Vice Chair Paul Hastings, Emerging Companies Chair Ted Love as well as past chairs Ron Cohen, Rachel King, John Maraganore and Richard Pops.

The current and former leaders of the trade group urged industry to commit to five tenets that would — under normal circumstances — be considered obvious best practices. And it warned that the loss of public trust brought on by failing to adhere to these principles would be severe, with consequences lasting far beyond the current crisis.

“If we do not allow and encourage the primacy of science and medicine in the assessment of these vaccines, then we will never be able to deal with the next pandemic, and that will be a real threat to America,” Levin told BioCentury.

The first two principles are a call to meet standards that are universally recognized, albeit not universally practiced. 

The BIO leaders said sponsors should conduct clinical trials according to best practices, with ethical participation of diverse populations of subjects, and disclose “important” clinical data at well-respected scientific meetings or in rigorous peer-reviewed journals, not in press releases alone.

“Companies should approach any pre-publication press activity thoughtfully,” with accurate descriptions of key data points and clear communication that full data will be submitted for peer review, they said.

The three other principles articulated in the letter — which ordinarily would have been taken for granted — reflect the unprecedented nature of the moment, in which political pressure is increasingly feared to be influencing drug development for COVID-19 (see “FDA Should Maintain Social Distance from White House”). 

BIO leadership said FDA needs to maintain its “historic independence as the gold-standard international regulatory body, free from external influence,”  to assure the public that any approved products meet required standards for safety and efficacy.  

Levin said the message isn’t that FDA should be doing things differently, but that others should let FDA do its job. He said BIO seeks to “provide a backdrop for decision-making inside FDA by expressing our support for its independence.”

The authors also said “the public should be assured that only rigorously considered data will dictate the subsequent use of any product,” and that varied reactions across different subpopulations must be considered when distributing vaccines. 

The “lightning speed” of COVID-19 vaccine development means populations recruited into the first rounds of late-stage trials won’t be representative of the general population, and “can’t translate into a mass population vaccine,” said Levin.  He said that it is important for sponsors to follow through on commitments to conduct postapproval trials in patients excluded from previous studies, and for the public to know those trials are happening.

The letter’s final principle was an appeal to “Republicans and Democrats alike” to put aside political considerations. “Our nation’s leaders should reassure the public that politics will not influence the development and approval of new medicines,” the authors wrote.

On Aug. 4, Sens. Maggie Hassan (D-N.H.), Mike Braun (R-Ind.), and Lisa Murkowski (R-Alaska) introduced the Safe Authorization for Vaccines during Emergencies (SAVE) Act with the goal of increasing safeguards and transparency for regulatory review of COVID-19 vaccines. The bill would codify requirements that the CDC’s Advisory Committee on Immunization Practices and FDA’s Vaccine and Related Biological Products Advisory Committee issue recommendations on the safety and efficacy of vaccines seeking emergency use authorization, including public recommendations on safety for priority populations.

Independent advisory bodies are an important source of validation, said Levin, adding that “we should all welcome a bipartisan approach to developing medicines and vaccines for this pandemic and the next.”

“If the bill contains strict conditions that insulate the vaccine approval process from political manipulation and ensures transparency and the independence of the FDA and CDC review bodies, we will all welcome it,” he said. 

Levin is chair and CEO of Ovid Therapeutics Inc. (NASDAQ:OVID); Hastings is president and CEO of Nkarta Inc. (NASDAQ:NKTX); Love is president and CEO of Global Blood Therapeutics Inc. (NASDAQ:GBT); Cohen is president and CEO of Acorda Therapeutics Inc. (NASDAQ:ACOR); King is founder and CEO of GlycoMimetics Inc. (NASDAQ:GLYC); Maraganore is CEO of Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY); and Pops is chair and CEO of Alkermes plc (NASDAQ:ALKS).

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