We can imagine the movie script already: Honest scientists try to keep unsafe medical devices off the market, but big bad Big Brother quashes their efforts and brands them as criminals. The New York Times reports today that the nine FDA scientists who wrote President Obama's transition team to complain of a "culture of corruption" at the agency now say officials may have placed them under criminal investigation.
"[U]s rather than the managers who have engaged in wrongdoing!" the scientists said in a letter to the president. "It is an outrage that our own agency would step up the retaliation to such a level because we have reported their wrongdoing to the United States Congress."
Backing up a bit: These scientists complained in May of improper device approvals to then-FDA chief Andrew von Eschenbach. He launched an internal review, which is ongoing. Five months later, the scientists feared the FDA was dragging its feet, so they wrote to Congress asking for an investigation. In November, the Committee on Energy and Commerce launched one. Then came their letter to President-elect Obama's team. (Incidentally, a Government Accountability Office report released two weeks ago confirmed some of the scientists' concerns.)
The Times obtained emails and internal documents about the dispute; apparently, at least one of the bones of contention is the fact that it can be illegal for FDAers to reveal information considered confidential by companies that have submitted products for review. But the scientists have upped the ante, too: Their letter to President Obama offered a list of laws they feel the agency has been violating. Stay tuned.
- read the NYT article