Prominent biotech leaders release Covid-19 guidelines calling for FDA independence, data transparency

A group of prominent biotech CEOs are calling on their peers and the federal government to hold themselves to the highest standards when it comes to developing and reviewing Covid-19 treatments.

Among their demands: That biotech companies don’t simply release clinical trial data in press releases, and that federal regulators make it clear to the public that any vaccines or treatments will be approved strictly based on science.

The recommendations were laid out in an open letter organized by the Biotechnology Innovation Organization and published Thursday. The letter comes amid growing concern among the American public over the politicization of the Covid-19 pandemic. A new poll conducted by STAT and Harris Poll found that nearly 80% of Americans worry that the Covid-19 vaccine development process is being driven more by politics than science.

“As data begin to emerge from clinical trials of an array of vaccines and therapeutics, we believe that it is important for us in the biopharmaceutical industry to articulate the principles we see as essential for assessing these data and determining their potential value,” wrote the leaders of eight biotech companies — including Alnylam Pharmaceuticals and Alkermes — and BIO President Michelle McMurry-Heath. “We believe that public health, and the public’s trust in new medical products, are dependent upon the integrity, transparency and objective assessment of new data as they emerge.”

BIO’s board chair, Jeremy Levin, put it more simply: “We want the public to believe and to trust what we are doing.”

Thursday’s letter lays out five principles, many of which are scientific best practices, such as ensuring that clinical trials are conducted “to assure credibility of the data, as well as the ethical participation of a diverse population of subjects.”

But the letter also explicitly presses industry players to release clinical trial data through “well-respected scientific meetings or rigorous, independent peer review journals.” The letter adds that any data included in press releases should be “clear and include accurate descriptions of key data points while reinforcing that the full data will be submitted for peer review.”

However companies disclose trial results, the letter makes one thing clear: “Data should not be released by press release alone.”

A handful of biotech companies and researchers have come under fire in recent months for not being transparent enough about their data. Moderna, one of the leaders in the race for a Covid-19 vaccine, and a BIO member, was widely criticized in May for unveiling in a press release that its vaccine candidate appeared to be generating an immune response in a Phase 1 trial.

“This is the equivalent of a chief executive of a public company announcing a favorable earnings report without supplying supporting financial data, which the Securities and Exchange Commission would never allow,” researcher and former biotech CEO William Haseltine commented at the time. “It’s damaging trust in the fundamental methods of science and medicine at a time when we need it most.”

BIO’s letter did not mention individual companies. Levin said that the point was “by no means” a rebuke of Moderna. Levin, in fact, defended Moderna’s actions.

“At early stages, it’s good to get information about where a company is going,” Levin said, regarding the Moderna Phase 1 data release. “There’s a qualitative difference between telling you where you are going and giving a result. While you might think that a Phase 1 is a result, a Phase 1 indicates the company is on track.”

“It’s at the end when the result is there that one’s looking for a different quality of data,” Levin added.

Levin and other biotech industry leaders also urged federal regulators to reassure the American public that any approval of an eventual Covid-19 vaccine or therapeutic will be motivated by science, not politics.

“Political considerations should be put aside by Republicans and Democrats alike,” the CEOs write. “Our nation’s leaders should reassure the public that politics will not influence the development and approval of new medicines.”

In particular, they say the Food and Drug Administration must “maintain its historic independence as the gold-standard international regulatory body, free from external influence.”

The FDA has openly struggled to retain its independence amid growing pressure from the White House to fast-track coronavirus vaccines and treatments prior to the November election.

In addition to McMurry-Heath and leaders of Alynylam and Alkermes, the letter was also signed by the CEOs of Ovid Therapeutics, Nkarta Therapeutics, Global Blood Therapeutics, Acorda Therapeutics, and GlycoMimetics. All of the signers have served within a leadership role at BIO.

“This is not just the current administration of BIO,” Levin said. “This is the totality of decades of the industry speaking at this moment saying we believe that science and medicine need to stand out.”

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