« Newdow Launches Another Salvo • The Rants • McCreary County Looking to Re-Try SCOTUS Case »
FDA Uses Stupid Excuses to Conceal Asinine Agenda
2005.11.15 (Tue) 20:20
A little over two months ago, we wrote about the FDA's ridiculous and illogical decisions concerning the Morning After Pill. Although research by an independent advisory committee and the recommendation from the FDA's own scientists supported the notion that the drug was safe for all ages, and hence should be available over-the-counter without a prescription, the FDA chose to ignore the evidence. Their reasoning? They didn't want minors to have access to the drug without consulting a doctor. So, at the request of the FDA, the drug company altered and resubmitted the proposal to allow only people who are sixteen or older to purchase the medication over-the-counter; instead of granting approval, the FDA lapsed into a round of incoherent babbling about not knowing how to enforce age restrictions on a product (are these idiots entirely unaware of the laws regulating the alcohol and tobacco industries?).
But as pointed out by Lindsay of Majikthise fame, the FDA wasn't ignoring the scientific evidence when they made their decision — it turns out that they made their decision long before the evidence was even available. Lindsay reports:
The non-partisan GAO published a report yesterday saying that FDA officials rejected Plan B's application to be sold over-the-counter months before the scientific review was completed.
According to a New York Times article concerning the GAO report:
In April 2003, Women's Capital applied to make Plan B available over the counter. Barr [Laboratories] bought the rights to the drug and continued to pursue the application. An advisory committed [sic] voted 23 to 4 in December 2003 to recommend approving the switch.
Within days of the committee's vote, however, Dr. Janet Woodcock, the F.D.A.'s acting deputy commissioner of operations, and Dr. Steven Galson, acting director of its drug center, told four top staff members that the application would be rejected, even though the agency's scientific review of the application had yet to be completed, the staff members told Congressional investigators. That review was completed in April.
Gee, it sure sounds like the decision was made months before the data had ever been analyzed. What does the FDA say about this particular finding?
Drs. Woodcock and Galson denied to investigators that they had made such statements.
Dr. Galson told them that "although he was '90 percent sure' as early as January 2004" that he would reject the application, he made his final decision only after reviewing the scientific evidence.
Fuck, that's not a denial; it's an admission with a minor clarification. What the hell is the difference between being 90% sure in early January 2004, and having already made the decision within days of the December 2003 advisory panel vote? Thanks for the Clinton-esque lesson in semantics, but to us, this is pretty much a flat-out admission of guilt by the FDA.
There's even more to it than this, though. It seems that the Morning After Pill had a very "unique" approval process within the FDA — one that differed significantly from the norm. Let's take a closer look at some of the points raised by the GAO investigation. All quotes below are from the New York Times article mentioned above.
The report suggested that it quickly became apparent that the agency was not going to follow its usual path when it came to the pill. "For example," it said, "F.D.A. review staff told us that they were told early in the review process that the decision would be made by high-level management."
So, basically, the decision was almost immediately taken out of the hands of the people actually doing the research and analyzing the data, and handed to a small group of high-level executives. As noted in the NYT article, this is not how things are usually done at the FDA. One has to wonder about the "special" treatment that the Morning After Pill apparently received.
From 1994 to 2004, F.D.A. advisory committees reviewed 23 applications to switch drugs from prescription to over-the-counter status. Plan B was the only one of those 23 in which the agency went against the committee's advice.
Sing along with the FDA: "One of these things is not like the other, one of these things just doesn't belong."
Dr. Galson...decided to issue a "non-approvable" letter to Barr, he said, because only 29 of 585 participants in a Barr study of the drug had been ages 14 to 16. None was under 14.
Dr. Galson said younger teenagers might act differently than older ones and might engage in riskier sex if they knew an emergency contraceptive was easily available. The company needed more data to ensure that this was not true, he said.
We suppose that over-the-counter availability of Advil might also make younger teenagers more likely to hit themselves in the head with a tack hammer, since pain relief is so easily available; but that hardly seems like a good reason to require a prescription for Advil. Feel free to swap out the over-the-counter drug and self-destructive behaviors above with any of your choosing — Ipecac and recreational poisoning, Claritin and wanton exposure to allergens — the point remains the same. What makes the Morning After Pill any different to the FDA? We think we can spell it out in three letters — S-E-X. The puritannical theocrats walk among us. Can we get an Amen?
That said, other than the fact that this basically amounts to the FDA legislating private and personal behavior by restricting access to a safe drug, it almost sounds logical of them to want to have more data on minors to review (not on their sexual behavior, as the FDA suggests, but rather on their reactions to the medication itself). However, that notion is quickly shot down:
But the G.A.O. called this rationale "novel" and said it was not in keeping with earlier agency decisions in which the behavior of older adolescents was routinely used to predict that of younger ones. The report also noted that the December 2003 advisory committee had voted 27 to 1 that Barr's study had demonstrated that consumers, adolescents included, could use the drug appropriately.
So, yet again, it is apparent that the FDA had a very special approval process for this drug's application.
In his rejection letter to Barr, Dr. Galson suggested two ways it could receive approval. First, it could perform another study that included more young adolescents. Or it could seek to sell the drug "behind-the-counter," making it easily available only to women 16 and older, with younger women still needing a prescription.
Barr took the second approach in an application filed in July 2004. Although the agency's rules required it to issue a decision in January, it has delayed doing so indefinitely.
It is unusual for the agency to suggest a means of approval to an applicant only to decide later that its own suggestion might not be appropriate.
Unusual? That's just a jumping off point for the vocabulary we'd choose to describe this farce.
The letter [from several senators and congressional representatives which asked for the investigation] noted that Congressional investigators had been unable to uncover the role in the Plan B decision played by the former agency commissioner, Dr. Mark B. McClellan, because agency officials told investigators that all of his e-mail messages and written correspondence on the subject had been deleted or thrown out. The Democrats charged that these acts contravened federal records laws.
Frankly, we couldn't care less that this guy is White House Press Secretary Scott McClellan's brother — irrelevant, irrelevant, irrelevant. The fact that anyone in his position appears to have, er, "lost" all of his records and e-mails certainly looks suspicious, to say the least (the very least). It isn't easy to accidentally lose everything you have on one particular topic, especially one this predictably explosive, so we're forced to wonder if — shocker coming up — maybe it wasn't accidental at all.
What's the response from the FDA on the GAO report? They deny everything, of course. According to FDA spokeswoman Julie Zawisza:
"We question the integrity of the investigative process that results in such partial conclusions by the G.A.O."
After all of the shit outlined above, they have the nerve to question the integrity of the folks investigating their outfit? Pull the other one, Jill — we're not buying your line of shit.
Maybe — just maybe — if the FDA was able to provide a single logically defensible reason for not allowing adults over-the-counter access to the Morning After Pill, we'd be more willing to listen to them. To date, we haven't heard anything even remotely approaching logic (or honesty) on this issue; and we're not confident that this will change any time soon.
— • —
[ Filed under: % Civil Liberties % Government & Politics % Religion ]
% Trackback » 2005.11.15 (Tue) 21:07
"86'ed" from The Flack
Now, as the facts begin to emerge, the FDA's communications team again finds itself in crisis mode trying to deflect these new allegations. [More]
Ron Zeno, 2005.11.16 (Wed) 10:42 [Link] »
The Two Percent Company, 2005.11.16 (Wed) 13:35 [Link] »
— • —