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Peter Rost, M.D., is a former Pfizer Marketing Vice President providing services as a medical device and drug expert witness and pharmaceutical marketing expert. Judge Sanders: "The court agrees with defendants' view that Dr. Rost is a very adept and seasoned expert witness." He is also the author of Emergency Surgery, The Whistleblower and Killer Drug. You can reach him on rostpeter (insert symbol) Please read the terms of use agreement and privacy policy for this blog carefully.

The FDA is Finished

The FDA is here to protect us and to ensure, among other things, safe drugs.

This is a tough task, a task which will often result in criticism.

And when the FDA is caught red handed making decisions that have nothing to do with science, and everything to do with politics and religion, the trust in the FDA effectively ends.

The FDA, as we know it, is finished, and here's why:

It was just revealed that two key Food and Drug Administration officials recently testified that former FDA Commissioner Lester Crawford took them out of the agency's normal drug approval process, in order for him to personally block over-the-counter sales of an important early pregnancy contraceptive or "morning-after pill."

We're talking about Crawford's decision in August 2005 to block nonprescription sales of Plan B even though the key agency officials wanted to approve them.

And who's behind this decision? The usual suspects. Conservative groups and religious fundamentalists have lobbied the FDA and the White House against nonprescription Plan B sales.

Religious fanatics argue that Plan B causes abortions, although the scientific truth is that the drug, when it's taken within 72 hours of unprotected sex, simply prevents pregnancy.

According to transcripts of the depositions, Dr. Steven Galson, director of the FDA's drug evaluation center, and Dr. Janet Woodcock, deputy operations commissioner, Crawford removed them from involvement in the agency's decision on Plan B.

Galson, who testified he was unhappy with the FDA's Plan B process, said: "What happened around that time frame is that Dr. Crawford, who was the acting commissioner then, told me that he was concerned about where we were heading because he knew that I was heading towards this recommendation [approval], and he told me that he was going to make the decision on what to do with the application."

He, he. Sounds different than when Galson motivated FDA's rejection of Barr's application for Plan B non-prescription sales earlier, in May 2004.

On May 6, 2004, Galson wrote in a memo: "Some staff have expressed the concern that this decision is based on non-medical implications of teen sexual behavior, or judgments about the propriety of this activity. These issues are beyond the scope of our drug approval process, and I have not considered them in this decision."

Right. The truth doesn't always get out, but sometimes it does.

So, in August 2005, Crawford blocked Plan B and said the FDA needed more time to consider a revised application from Barr to allow Plan B sales without a prescription to women 16 and older but with a prescription to girls 15 and under.

Dr. Susan F. Wood, the FDA's top women's health officer, then resigned in protest over Crawford's handling of this matter.

The end of the saga is that the drug is still not approved without a prescription and Dr. Crawford the former, eminent FDA czar, is now under investigation himself.

The criminal investigation of Dr. Crawford by a federal grand jury over accusations of financial improprieties and false statements to Congress, was revealed only a month ago. Dr. Crawford resigned in September 2005, less than three months after the Senate confirmed him as the permanent FDA commissioner, a position which he had held on an “acting” basis for a couple of years. He said then that it was time for someone else to lead the agency.

Yep, criminal charges can do that to you. Time to move on.

Question is when the clowns who are messing with our healthcare system and approval of vital drugs will be charged with their crimes.


Anonymous ORSunshine said...

Dr. Rost,
This is really great. I have been following the Crawford controversy, and I'm glad to hear that the Plan B prescription-only policy was, as I suspected, a political decision. Good that it has been exposed!
Though, I don't know how much this will really shake up the goings-on at the FDA. I look forward to watching that progress.

Blogger MsMelody said...

What has happened with Plan B --the undermining/removal of key evaluators to prevent a drug from being marketed—is the exact opposite of what happened with the approval of rDNA insulin. Addressing this in his book “Too Profitable to Cure,” Brent Hoadley has written:

The FDA approved the new process for making rDNA insulin in 1982, along with the resulting product—human insulin. At the time, the approval process for new drugs, from application to approval, was completed in approximately two years.

Remarkably, rDNA insulin garnered FDA approval in only five months, despite the fact that the process was entirely new and without precedent for evaluation.

Fortunately for the FDA and Eli Lilly, Henry I. Miller10 had come to the agency from the new biotech industry. A self-proclaimed authority in this developing area, Miller, who was only a division head, was initially stymied in his efforts to garner approval for Lilly’s genetically engineered insulin. His boss, the agency head, had concerns about this new product and methodology, especially since long-term safety studies were unavailable. Miller recently admitted how, when the agency head went on vacation, he convinced the acting head to sign off on the approval process, and expeditiously rubber-stamped the approval.

Lilly’s approval for Humulin ranks eighth on the FDA list of ten fastest drug approvals. All the drugs that have received speedier approval were products of “fast-tracking”—a procedure the government implemented 10 to 14 years after the advent of human insulin.

If nothing else, this shows us that the more things change, the more they stay the same. This action occurred in the early 1980s, and essentially presented a roadmap for other unworthy acts that we have witnessed over the past two decades.


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