GOTTLIEB SHAKE-UP COMING TO FDA (Orthopedics This Week)
The U.S. Senate approved Scott Gottlieb, M.D. as the next FDA Commissioner on May 9 by a vote of 52 to 47.
Deregulation Advocate
Gottlieb has a track record as an advocate for deregulation and was on President Trump’s transition team. Earlier, he was a senior adviser to the presidential campaign of Wisconsin Governor Scott Walker. In addition to being an industry consultant, he previously served as a deputy FDA commissioner and a high-ranking official at the Centers for Medicare and Medicaid Services (CMS) during the George W. Bush administration.
He's also been an advocate of speeding the approval process through shorter trials. He has also criticized the agency as being too restrictive in its views on “off-label” promotions. With federal courts applying First Amendment free speech rights to device manufacturers providing truthful "off-label" information, we are likely to see dramatic changes in that area.
“Longer, larger trials that require drug makers to evaluate 'hard' endpoints (like how long a cancer patient lives) rather than 'surrogate' endpoints (like a drug's ability to shrink tumors) give FDA reviewers more statisti...
