Pharma Manufacturing
Mon, 12/08/2008
I thought the whole "Rost for FDA Chief" that surfaced after John Mack's recent poll was a joke, but then read that Dr. Rost, who emerged as the favorite candidate in that poll, has received the backing of at least two members of Congress.
Wouldn't it be interesting to see an FDA headed by an industry gadfly? Dr. Rost, as an M.D., is qualified for the title. However, he has spent most of his career in marketing, so he's been distanced from the science, which is changing rapidly and becoming quite complex, especially in areas such as followon biologics and pharmacovigilance....(but how many recent FDA chiefs have been on top of all the science. In theory, Chief Rost could delegate all that, preferably to someone like Janet Woodcock).
But if Peter Rost as FDA chief seems a bit of a stretch, I could easily see him appointed by the Agency as special advisor on pharma marketing practices, a sort of pharma marketing ethics czar. (If he gave up seeking remuneration from his lawsuit.)
As he's said all along, Rost doesn't hate the industry....although one wonders how objective he'd be in decisions involving Pfizer.
Whatever comes of this latest news, Dr. Rost has become the "Madonna" of whistleblowers, changing his image and strategy, staying in the public eye and keeping people interested in what he has to say.
Pasted below, an article by Lee Howard, published in Friday's edition of The Day.
-AMS
If Pfizer Inc. were to describe its worst nightmare, it might very well be seeing former company whistleblower Peter Rost become commissioner of the U.S. Food and Drug Administration.
So guess who is actively seeking the FDA's top post?
Rost, a former Pfizer vice president who turned whistleblower after he alleged that a subsidiary of the company started promoting off-label uses of various drugs, not only is in the running for FDA commissioner, but he has at least two congressmen in his corner.
This week, the Web site Pharmalot reported that U.S. Sen. Sherrod Brown, D-Ohio, would be sending a letter of recommendation for Rost as well as several other candidates for the post. Rost also has picked up support from U.S. Rep. Bart Stupak, D-Mich., chairman of the Oversight and Investigations subcommittee of the House Energy and Commerce Committee, who has been involved in many investigations of the FDA.
"I encourage you to seek meaningful reform of the FDA, which begins with a complete change in the FDA's leadership," Stupak wrote in a letter to president-elect Obama endorsing Rost's candidacy.
Rost said he is looking for a shakeup of the FDA, including a reorienting of the agency's priorities from serving the drug industry to helping American citizens.
"That means the agency would focus not only on the fastest and most efficient processing of new drug applications, but would also ensure that unsafe drugs are taken off the market or labeling (is) revised in a more timely manner," Rost said in an interview this week with eDrugSearch. com, which endorsed his candidacy.
Some of Rost's most controversial stances include his views on reimportation of drugs from Canada, which he approves, and his opposition to direct-to-consumer advertising.
"DTC advertising is not part of a 'free market' - it is part of manipulation of consumers who don't know better and doctors who give the patient whatever they ask for," Rost said.
Pfizer fired Rost in 2005 after it became known that the marketing executive's allegations about off-label promotion of drugs had led to a criminal investigation against the company.
Rost went on to write a bestseller about his experiences, titled "The Whistleblower: Confessions of a Healthcare Hitman," which detailed payouts to doctors, marketing drugs to children and various illegal and unethical activities he said he witnessed.
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