Tuesday, August 01, 2006

F.D.A. Shifts View on Next-Day Pill

And it's about damned time. I mean, please, look at the state of the opposition to this method:

One conservative organization, Concerned Women of America, voiced opposition to the plan.

“There’s clearly no way that the F.D.A. or Barr Labs could put a gender restriction on who buys the drug,” said Wendy Wright, the president of that group. “You could have a statutory rapist buy the drug in order to cover up his abuse.”

Yep, how about all those date rapists who mix royphonol with morning after pills to make sure they don't leave a trace? Jesus, morons. Oh, wait, I guess that's kind of the point...Jesus, I mean. Whatever.

F.D.A. Shifts View on Morning-After Pill

By STEPHANIE SAUL

The Food and Drug Administration said yesterday that it was moving toward endorsing sale of the morning-after pill without a prescription for women 18 and older, signaling what may be the end of one of the most stubborn health policy debates of the Bush administration.

The agency’s acting commissioner, Dr. Andrew von Eschenbach, asked the drug’s manufacturer, Barr Pharmaceuticals, for a meeting to complete plans that would allow the over-the-counter sale of the emergency contraceptive, called Plan B. In a statement, the F.D.A. said it hoped “the process can be wrapped up in a matter of weeks.”

While the agency’s letter to Barr was not a final approval, both the F.D.A. and the company expressed optimism about the drug’s future.

An agency spokeswoman, Susan Bro, said the move was intended to bring “this particular issue to a conclusion,” and a federal health official said the agency was committed to making the drug available over the counter.

“We see this as a positive development,” said Carol A. Cox, a spokeswoman for Barr.

In 2003, an F.D.A. advisory committee voted 23 to 4 to allow the drug’s over-the-counter sale without age restrictions. But a top official of the agency overruled that committee and agency staff members, raising concerns that young teenagers might engage in riskier sex if the morning-after pill was easily available. The company revised its application, asking that over-the-counter sale be allowed for women older than 16.

In the letter sent yesterday, Dr. Von Eschenbach said the agency would not approve that request but that, if the company met certain restrictions, it would allow over-the-counter sales to women 18 or older.

It is up to Barr to assure the agency that the drug would not be sold to those under 18. The company has said that it has already developed a program to restrict sales.

Under that program, Plan B would not be available in convenience stores or at gasoline stations, but only in places where there is a pharmacy. Rather than being placed on drugstore shelves, the contraceptive would be behind a pharmacy counter. To buy it, women would have to show photo identification to prove their age.

Many women’s groups expressed cautious optimism that the announcement meant that the drug’s over-the-counter sales would finally be approved. The drug is most effective when taken soon after intercourse, the reason its supporters have argued that it should be available without a prescription.

Planned Parenthood, which has supported the drug’s over-the-counter availability, issued a statement saying that the agency’s announcement “holds the potential for improving women’s health if the F.D.A. keeps its word this time.”

But the timing of the announcement — the day before Dr. von Eschenbach’s confirmation hearing in a Senate committee — raised skepticism on Capitol Hill about whether it might be intended to deflect criticism about delays in the drug’s application without a clear guarantee of action.

“Today’s announcement is nothing more than a delay tactic,” Senators Hillary Rodham Clinton of New York and Patty Murray of Washington, both Democrats, said in a joint news release. The senators are members of the Health, Education, Labor and Pensions Committee, which is scheduled to hold its hearing on Dr. von Eschenbach today but is not scheduled to vote.

Assuming that the committee approves Dr. von Eschenbach’s nomination, Mrs. Clinton and Ms. Murray said they would block a floor vote on his confirmation until the F.D.A. made a final yes-or-no decision on the drug’s sale. Under Senate rules, any senator may place a “hold” on a floor vote to approve a nominee.

The senators removed a similar hold last year that had blocked a former F.D.A. commissioner, Lester Crawford, who then faced confirmation hearings. At that time, Dr. Crawford assured them that a decision on the drug would be made by Sept. 1, 2005, the senators said.

“We lifted our hold in July 2005 on Dr. Crawford’s nomination after receiving assurances that the F.D.A. would act by September,” Mrs. Clinton said. “Instead, what they did was to make a decision, and their decision was not to make a decision. Almost a year later, we’re still waiting for a decision.”

Ms. Bro, the agency spokeswoman, said the letter’s timing yesterday was partly related to today’s Senate committee hearing because Dr. von Eschenbach felt strongly that he wanted to inform the committee of the agency’s framework for moving on Plan B. It was a “transparent, science-led process,” she said.

“This is a model for how he currently makes decisions and will continue to as the leader of this critically important public health issue," Ms. Bro said.

One conservative organization, Concerned Women of America, voiced opposition to the plan.

“There’s clearly no way that the F.D.A. or Barr Labs could put a gender restriction on who buys the drug,” said Wendy Wright, the president of that group. “You could have a statutory rapist buy the drug in order to cover up his abuse.”

A group called Advocates for Youth, a national nonprofit organization, said it was concerned that many sexually active teenagers would not have access to the emergency contraceptive.

“We are gravely concerned that once again politics, rather than science, is at play and the most vulnerable women — teens — will be penalized,” said the group’s president, James Wagoner.

The emergency contraceptive is actually a two-pill regimen containing a high dose of drugs used in birth-control pills. It is already available by prescription without age restrictions and is designed for emergency use by women who have unprotected sexual intercourse. It is also available in nine states without a prescription, under certain conditions.

To be effective, the first pill must be taken within 72 hours after intercourse. The second pill is supposed to be taken 12 hours after the first.

Plan B was first approved for sale in the United States as a prescription drug in 1999. Barr moved in 2003 to make it available without age restriction over the counter, but its approval has been the subject of a series of F.D.A. delays.

Critics of the agency, including a former women’s health official who resigned over Plan B, have said that the decision-making process has been bogged down in political delays inspired by reproductive policy conservatives influential within the Bush administration, including abortion opponents, who view the drug as a form of abortion because it is taken after intercourse.

Dr. Crawford initially signaled that the government might go along with over-the-counter sales to women 17 and older. But saying that the agency had never approved an over-the-counter drug at the same dosage and administration as a prescription drug, he initiated a review to determine whether a new rule-making process was necessary.

Dr. von Eschenbach, a urology surgeon who has directed the National Cancer Institute, was appointed after Dr. Crawford resigned last year.

In a letter yesterday to Barr’s subsidiary Duramed, Dr. von Eschenbach said the review had concluded that no rule-making was necessary, clearing the way for final consideration of the company’s application.

Dr. Susan Wood, who resigned as director of women’s health for the drug agency last year in protest over its handling of Plan B, said the agency reviewers had believed the drug safe for younger women. Still, Dr. Wood said yesterday that she was “heartened” at the possibility for a positive outcome for the drug raised by Dr. von Eschenbach’s letter.

Shares in Barr, based in Woodcliff Lake, N.J., closed up 93 cents yesterday at $49.76.

Some products, like nicotine gum, are already kept behind the counter and require proof of age for purchase.

Dr. Jennifer Wu, an obstetrician and gynecologist at Lenox Hill Hospital in Manhattan, said she gave many of her patients who use condoms for contraception Plan B prescriptions to keep in their purses. “Really having Plan B over the counter will help those patients who don’t necessarily have an ob-gyn at the time,” Dr. Wu said.

Dr. Wu said that having the drug available over the counter would also increase education about the drug. “Some women do not know about it,” she said.

The spokeswoman for Barr Laboratories, Ms. Cox, said the company did not yet know how quickly it could market the over-the-counter product. Currently, the drug costs about $25 by prescription, but Ms. Cox said the company would probably charge more for the over-the-counter version to recoup costs associated with monitoring its sales.

Posted by crimnos @ 9:31 AM