Drugs

11 Republicans See FDA/Industry ‘Revolving Door’

David McFarland

— 2 min read
Share

Six Republican senators and five GOP House members have written to FDA commissioner Robert Califf, HHS secretary Xavier Becerra, and National Institutes of Health (NIH) acting director Lawrence Tabak raising questions about a “revolving door” between FDA and major drug companies. The letter is based on a Project Veritas interview with supposed Pfizer vaccine employee Jordon Walker, in which he said most FDA drug reviewers will eventually leave to work in the industry.

“It’s pretty good for the industry to be honest,” Walker said. “It’s bad for everybody else in America.” He said the problem is that when the regulators reviewing drugs know that once they stop regulating they will go to work for a drug company, “they are not going to be as hard towards the company that’s going to give them a job.”

The letter says that Walker’s description of Pfizer’s relationship with FDA “sounds like regulatory capture, in which regulators seek to advance commercial interests rather than the public’s interest. If true, regulatory capture of FDA is troubling for two primary reasons. First, it subordinates public safety to personal gain…. Second, regulatory capture is fundamentally unfair to smaller companies without the clout to affect agency decisions.”

A second controversial aspect of Walker’s interview involves his claim that Pfizer is considering conducting “directed evolution” research to improve the efficacy of its Covid-19 vaccine. The congressional members say directed evolution research sounds like “gain-of-function” research that some have claimed, without definitive proof, was the root cause of the Covid-19 pandemic when an enhanced virus leaked from China’s Wuhan Institute of Virology, which reportedly was conducting gain-of-function research.

Walker stated his opinion that Covid-19 likely originated from a lab leak, given the virus’ potency and rapid spread. “Given the possibility that gain-of-function research may have ignited the global pandemic, it is worrying that Pfizer is engaging in research that appears similar in nature,” the letter says.

The 11 Republicans ask for answers to these questions:

  • do FDA and NIH subject matter experts consider a Pfizer plan to mutate SARS-CoV-2 itself to preemptively develop new vaccines to be gain-of-function research and if not, what the distinction is;
  • the steps that have been taken to ensure that all FDA officials treat firms equally, regardless of size or market power;
  • the steps FDA has taken to guard against regulatory capture and conflicts of interest among its employees; and
  • whether the agencies are aware if Pfizer has conducted gain-of-function research or directed evolution research for its Comirnaty Covid-19 vaccine, which the lawmakers say is legally distinct from its Pfizer/BioNTech Covid-19 vaccine.

As rumors about Pfizer's research started to circulate in January, the company issued a statement denying that it has conducted GOF or directed evolution research. "Working with collaborators," it said, "we have conducted research where the original SARS-CoV-2 virus has been used to express the spike protein from new variants of concern. This work is undertaken once a new variant of concern has been identified by public health authorities. This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern."

It also described its research work on the Paxlovid treatment and said the types of studies it conducts are required by U.S. and global regulators for all antiviral products and are carried out by many companies and academic institutions in the U.S. and around the world.

The Project Veritas claims that are the basis for the letter from the senators and representatives have been debunked in a lengthy and detailed PolitiFact fact-check that notes the questions that have been raised about how Project Veritas makes and edits its videos, its inability to verify Walker’s employment by Pfizer through his name or title, and the analysis by an academic scientist that Pfizer has not conducted gain-of-function research.

Read more