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Posted On: 09/21/2022 9:17:31 PM
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There have been lots of posts about big pharma having influence over the FDA, but I don't remember seeing anything about political influence. I am posting below an article from MedPage Today about a congressman pressuring former FDA Commissioner Stephen Hahn concerning a stem cell product. I copied the entire article, but I am also posting the link in case anyone wants to see it on their website.
Former FDA Commissioner Pressured Via Text for Drug Company Favors
Paul Knoepfler, PhD, a stem cell expert with a long-running science blog called the Niche, reported that former FDA commissioner Stephen Hahn was pushed to fast-track a stem cell product called ExoFlo under pressure from a Texas Congressman.
ExoFlo is an exosome product made from human bone marrow mesenchymal cells and growth factors that's delivered intravenously. Company Direct Biologics wanted to study its ability to treat COVID-19, although Knoepfler wrote, "It's not clear and convincing to me as a stem cell researcher how an IV infusion of ExoFlo or other exosomes could be expected to help COVID."
A series of texts released in what Knoepfler calls an "FDA FOIA dump" suggests that Texas representative Michael McCaul and his wife Linda Mays McCaul contacted Hahn directly about Direct Biologics to usher it past regulatory hurdles. That included trying to secure an Investigational New Drug (IND) application so the company could conduct the clinical trials, which could then lead to premarket approval of the product.
The texts include requests from Rep. McCaul to arrange meetings between the company and Peter Marks, MD, PhD, director of FDA's Center for Biologics Evaluation and Research.
"I was told this is a 'new FDA,' and not the old bureaucratic one," McCaul texted Hahn. "I am concerned by the lack of urgency demonstrated by your staff given the tremendous loss of life during this pandemic."
McCaul later said, "If I do not hear from you or your staff in the near future I will have no other choice but to raise this issue to a higher level," which Knoepfler speculated may have meant complaining to "Trump or his inner circle."
https://www.medpagetoday.com/special-reports/...eMD_Active
Former FDA Commissioner Pressured Via Text for Drug Company Favors
Paul Knoepfler, PhD, a stem cell expert with a long-running science blog called the Niche, reported that former FDA commissioner Stephen Hahn was pushed to fast-track a stem cell product called ExoFlo under pressure from a Texas Congressman.
ExoFlo is an exosome product made from human bone marrow mesenchymal cells and growth factors that's delivered intravenously. Company Direct Biologics wanted to study its ability to treat COVID-19, although Knoepfler wrote, "It's not clear and convincing to me as a stem cell researcher how an IV infusion of ExoFlo or other exosomes could be expected to help COVID."
A series of texts released in what Knoepfler calls an "FDA FOIA dump" suggests that Texas representative Michael McCaul and his wife Linda Mays McCaul contacted Hahn directly about Direct Biologics to usher it past regulatory hurdles. That included trying to secure an Investigational New Drug (IND) application so the company could conduct the clinical trials, which could then lead to premarket approval of the product.
The texts include requests from Rep. McCaul to arrange meetings between the company and Peter Marks, MD, PhD, director of FDA's Center for Biologics Evaluation and Research.
"I was told this is a 'new FDA,' and not the old bureaucratic one," McCaul texted Hahn. "I am concerned by the lack of urgency demonstrated by your staff given the tremendous loss of life during this pandemic."
McCaul later said, "If I do not hear from you or your staff in the near future I will have no other choice but to raise this issue to a higher level," which Knoepfler speculated may have meant complaining to "Trump or his inner circle."
https://www.medpagetoday.com/special-reports/...eMD_Active
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