GAO discovers anomaly in FDA decision on contraceptive Plan B

[DealMonkey]

The GAO, the investigative arm of Congress, has discovered (big surprise!) that the FDA decision to reject the contraceptive "Plan B" for OTC sale deviated dramatically from its previous decisions in such matters.

Surprise! Reproductive rights and this administration seem to cancel each other out. It's business as usual as the Bush Admin decides these issues "from the heart" rather than from the brain. I'm quite sure Bush can't trust those scientists with all of their facts and wants these sort of decisions left to Pat Robertson, or someone equally responsible.

:roll:

All right! More forced Christian "values" for the U.S.!

FDA's Rejection of Contraceptive is Questioned

The Food and Drug Administration did not follow its usual procedures in rejecting an application for over-the-counter sales of the emergency contraceptive pill Plan B, the investigating arm of Congress found today.

The Government Accountability Office also said in its 57-page report that there were questions about whether top officials of the F.D.A. made the decision to reject the application for over-the-counter sales of the drug, which is opposed by some religious conservatives, even before its own advisory committee had issued its recommendation on the matter.

Several legislators and scientists have complained that the F.D.A. was putting politics ahead of science in its handling of the contraceptive, which can be used as emergency, morning-after contraception.

The G.A.O. said in its report that "the Plan B decision was not typical of the other 67 proposed" changes from prescription to over-the-counter sales that the agency received from 1994 through 2004.

The agency, which was charged with examining how the decision to reject the application was made, and how it compared to the decisions of other requested changes from prescription to over-the-counter sales, does not make recommendations about what action the F.D.A. or Congress should make in the matter.

But critics of the decision used the report as the basis to ask that the F.D.A. decision be revisited.

"We are deeply opposed to this subversion of science," Representative Henry Waxman, Democrat of California, wrote to Health and Human Services Secretary Michael O. Leavitt, in a letter signed by 17 other lawmakers.

They urged Mr. Leavitt, who oversees the F.D.A., to intervene to assure that a pending reconsideration of the pill's status "is based on the best available science instead of ideology."

Two Democratic senators, Hillary Rodham Clinton of New York and Patty Murray of Washington, issued a joint statement saying the report showed that the rejection of Plan B "was a politically motivated decision that came down from the highest levels at the F.D.A."

In May 2004, the F.D.A. rejected an application by Barr Laboratories to sell its Plan B contraceptive over the counter without restrictions, saying the company's studies did not include enough girls younger than 16.

This came after the agency's own nonprescription drugs advisory committee and its review staff recommended approval.

Last month, a consultant to that advisory panel, Dr. Frank Davidoff, editor emeritus of the Annals of Internal Medicine, resigned in protest of the agency's handling of the Plan B contraceptive, saying it was putting politics over science. In August, the top women's health official at agency, Susan Wood, also quit in protest over the Plan B decisions.

The G.A.O. report suggested that top F.D.A. officials had discussed turning down the application for over-the-counter sales of Plan B as early as December 2003, even though its advisory panels had not yet weighed in.

It also said that in Barr's application to switch Plan B from prescription to over the counter sales, or O.T.C,, as the agency calls it, "F.D.A.'s high level management was more involved in the review of Plan B than in those of other O.T.C. switch applications."

In its response to the G.A.O.'s draft report, Jane Woodcock, deputy commissioner for operations at the F.D.A., said it was "inaccurate" to suggest that a decision had already been made to reject the application before the review committees weighed in. She said, however, that "it was entirely normal" for top officials "to convey to the review division their concerns regarding the application."

She also said the Plan B case had attracted a high level of "public interest," including two citizen petitions. Top level officials were involved in the review process, she said, but only to the extent that it was "typical for high-profile, controversial applications."

Correction: An earlier version of this online article, about a report on the Food and Drug Administration's action on an emergency contraceptive pill, used an outdated name for the Congressional agency that issued the report. It is the Government Accountability Office; the agency changed its name from the General Accounting Office in July 2004.

 

[Shuxclams]

Its been proven as safe, but alas.......













SHUX

 

[Proletariat]

LOL that SHUX always throws me off :laugh:

 

[preCRT]

Originally posted by: DealMonkey

It's business as usual as the Bush Admin decides these issues "from the heart" rather than from the brain...

Two thoughts:

They can't use what they don't have

Can't use their heads when it's too far up their arses

 

[Mean MrMustard]

Don't worry, Zen & Co. will be in here shortly straighten this out.

Politics? Bah...

 

[BoberFett]

Absolutely the FDA is politicized. But to think it's only been since Bush became president is foolish. The FDA has been a tool of big business for decades.

 

[BaliBabyDoc]

When I was a college kid, I wanted to be FDA commish like my hero David Kessler. But the job sux. Industry wants quick approvals and few questions asked. Meanwhile, turds in Congress carry industry water like the crack whores they are.

Kessler was a rare breed in that he had the personal and intellectual aptitude to execute his responsibility to deliver safe AND effective products to the public . . . not to fulfill industry or political agendas.

It's a shame such an importance government function has fallen prey to the Bush anti-science idiocy.

If you study the history of the FDA, you will find it has RARELY been a tool of industry. In fact the relationship has typically been adversarial. The problem is that industry pads a lot of pockets in Congress. The arseholes in Congress then write BS laws that impede FDA's work. FDA is still amongst the best regulatory bodies in the world but the political appointees during Bush's tenure (and extramural . . . shadow adivsory panels) are one of the worst corruptions to befall the agency . . . EVER!

 

[db]

USAToday Editorial/Opinion 11/16/2005

"At FDA, religion tops science

Last year, when the Food and Drug Administration rejected an application to let the "morning-after pill" be sold without a prescription, eyebrows were raised.

More than 70 leading medical and public health groups had said that the pill, which can prevent a pregnancy if taken within 72 hours of having sex, is safe and should be available over the counter.

Now, the non-partisan Government Accountability Office reports that the FDA's review of the application was highly unusual, confirming suspicions that the process was tainted by politics. Specifically, the politics of religion and morality. In effect, groups that believe use of the pill constitutes abortion and encourages promiscuity were able to impose their views on everyone else. In a nation founded on values of religious freedom and personal choice, that's an outrage.

Specifically, the GAO found that:

? Top FDA officials, knowing the issue was politically sensitive, had "unusual involvement" in the review process. Some agency scientists alleged that those officials made the decision to reject the emergency contraceptive, known as Plan B, months before the scientists even concluded their research.

? Plan B's request for over-the-counter status was the only one of 23 applications that was rejected after expert advisory committees had recommended approval. The rationale for rejecting it ? fears that younger adolescents might not have the maturity of older teens ? was novel and didn't follow FDA's traditional practices. All other contraceptives approved by FDA are available to anyone, regardless of age.

The FDA's mission is to make sure that only safe and effective drugs reach patients. It does this by evaluating scientific studies and advice from medical experts. The agency isn't supposed to choose sides in the nation's culture wars, much less abandon science in favor of agendas that have more to do with religion and morality.

Nor is the abortion argument even valid.

Plan B could cut in half the 3 million unintended pregnancies and 1.3 million abortions each year, says Barr Laboratories, which markets Plan B. FDA says the pill doesn't affect an existing pregnancy, although abortion opponents claim it does and could also promote teen promiscuity.

FDA disputes GAO's conclusions, but its history with Plan B taints its credibility. Any other drug with a similar record of safety and effectiveness would have been approved long ago, an editorial in the New England Journal of Medicine concluded last year.

It's disturbing that the FDA caved so readily to pressure. Even more disturbing, though, is what might happen in the future. Some advocacy groups have already expressed concerns about a new vaccine, expected to be approved next year, that protects against cervical cancer caused by sexually transmitted diseases. The groups promise to "monitor" FDA actions because of worries that approval of the vaccine could send a message that condones sexual activity before marriage.

It isn't the FDA's job to police teen sexual behavior, much less enforce religious doctrine. Its capitulation to abortion politics betrays its own history and the nation's values. "

 

[preCRT]

60 minutes first story tonight is about the FDA's ignoring science and their own studies to put religion and politics above the rights of rape victims and others who need access to Plan B.