Morning-After Pill: Politics and the F.D.A.

[rodeodance]

http://www.nytimes.com/2005/08/28/politics/28pill.html?th&emc=th



August 28, 2005

Morning-After Pill: Politics and the F.D.A.

By GARDINER HARRIS

On Friday, the food and drug commissioner, Lester M. Crawford, announced that he would indefinitely postpone a ruling on Plan B, the morning-after pill made by Barr Laboratories. He explained that while the science supported over-the-counter access for women 17 and older, the agency had not figured out how to do that without younger teenagers getting the pills.......


As the months passed, two Democratic senators who support abortion rights, Hillary Rodham Clinton of New York and Patty Murray of Washington, vowed to block any vote on President Bush's nomination of Dr. Crawford to become agency commissioner unless the F.D.A. made a decision on the pill, for or against. Mr. Bush has long been aligned with abortion opponents.

The senators relented in July after the secretary of health and human services, Michael O. Leavitt, promised that a decision would be made by Sept. 1. On Friday, both senators attributed Dr. Crawford's latest announcement to political interference.

Dr. Robert Fenichel, a former deputy division director for cardiovascular and renal drugs who left the F.D.A. in 2000, agreed, saying the agency's decisions on Plan B were being driven by abortion politics.

"I've never seen anything like this before," Dr. Fenichel said......

[China_cat]

1. A kid can get an abortion at any age

without anybody's consent and they're worried about someone under 17 being able to PREVENT a pregnancy and possible abortion?

[Demeter]

2. He's Never Seen Anything Like This Before????

Where has he been since forever? From the arguments against women voting (it will damage their uteruses) or getting education (ditto) or family planning, or divorce, the Equal Rights Amendment (remember women dying on America's battlefields? That was a telling argument against ERA) or equal pay: it's ALWAYS been like that. And just as we were making some progress on changing that forever, Reagan and Bush and the GOP and the christofascists went into full panic mode to muddy the water, pull out the protections and screw over women yet again.

Oh yes, on this Sunday, let's not forget the classic argument: Do women have souls, or are they something less than Man?

I spit on them all.

[Demeter]

4. kick

[no_hypocrisy]

3. Cigarettes and alcohol are legal and are sequestered from consumers

under 18. Condoms, etc. are sometimes kept behind the counter at pharmacies. These are over-the-counter and yet screened from particular demographics. Morning-After Pills shouldn't be more difficult to control than these items.

[rodeodance]

5. the age of the women is not in question according to medical reports.

I got this as an email newsletter this morning:

American Progress Action Fund wrote:

http://www.americanprogressaction.org/site/apps/nl/content2.asp?c=klLWJcP7H&b=914257&ct=1355241

No Plan B

On Friday, the Food and Drug Administration indefinitely postponed its decision on whether the emergency contraceptive Plan B, more commonly known as the "morning-after pill," could be sold to women without a prescription. Nearly two years have passed since the drug was approved for over-the-counter (OTC) use by an independent panel of experts, then rejected by FDA partisans catering to the president's right-wing base. With this latest delay, the Bush administration has fundamentally undermined its claim to represent the "culture of life." Top medical groups believe that fully half of the nation's annual 3 million unintended pregnancies and 1.3 million abortions could be prevented if Plan B were available without a prescription. President Bush's FDA is again putting politics over science, women's health, and responsible abortion prevention.

ANOTHER BROKEN PROMISE: The FDA's latest delay is especially aggravating since the agency's current commissioner, Lester Crawford, was confirmed for his position only after promising Senators Hillary Clinton (D-NY) and Patty Murray (D-WA) that a decision on Plan B would be made by September 1. (Clinton and Murray are now calling for additional Plan B hearings.) The September deadline was itself a delay. "Under federal regulations, the Food and Drug Administration was required to reach a decision on Plan B by January," the New York Times reports. Now even some former Bush administration officials are alarmed. "At some point, the statute requires that the agency make a decision," Dr. Eve E. Slater, an assistant secretary of health from 2001 to 2003, told the Times. "You can't just delay forever." The Plan B decision has become "overly politicized, and it shouldn't be," Dr. Slater added.

SCIENCE IS "OVERWHELMING": The safety and effectiveness of the Plan B pill has not been seriously questioned since 1999, when the drug was first approved for prescription use. "More than 70 leading medical and public health groups, including the American Academy of Pediatrics and American College of Obstetricians and Gynecologists, say it's safe and should be available without a prescription or any age restrictions." (Why without a prescription? Primarily because the pill needs to be taken within 72 hours of sex, and it is often impossible for women to get an appointment and a prescription from a doctor in that time.) Moreover, a study by the University of California of more than 2,000 California women concluded easy access to the emergency contraceptive "did not lead them to engage in more risky sexual behavior." Panel drug expert Alastair Wood said "the science was overwhelming" on Plan B. Another expert said the FDA's decision not to approve over-the-counter status was "blatantly contrary to the science and the facts."

AGE CHECK NO ARGUMENT: In USA Today, the director of a cultural conservative group, Family-Pac Federal, cheered the FDA ruling, saying that if Plan B were approved for OTC purchase by adults, "Hard-working and over-stressed pharmacists would be turned into bartenders trying to determine a woman's age and identification. Welcome to the world of teenage fake IDs, Walgreens." Except Walgreens and other pharmacies already inhabit that world. In a report earlier this month, the Associated Press noted that if OTC sale of Plan B was approved, "Cash registers could be programmed to block purchase pending an age check. That's doable: Walgreens, the nation's largest drugstore chain, just last month took that step to prohibit sales to minors of cold medicines containing a sometimes-abused ingredient."

DO AS WE SAY (THEN WE'LL REJECT YOU ANYWAY): The FDA justified the latest delay by claiming that the application submitted by Barr Laboratories Inc., the makers of Plan B, had "raised complicated and unresolved issues about whether current regulations allow a drug to be legally sold by prescription only for teenagers but over the counter for all others." So why did Barr submit an application requesting adults-only OTC sale of Plan B in the first place? Because the FDA told them to. After Barr's first application was rejected in May 2004, "the FDA advised Barr Laboratories to submit another application that allowed over-the-counter sales only to women older than 17. That was the plan that was deemed to be impossible to resolve yesterday," the Washington Post reports.......