The U.S. Food and Drug Administration said Thursday that adults can get the emergency contraceptive Plan B - also known as the morning-after pill - without a prescription, resolving a lingering political debate that had caused divisions inside and outside the agency.
Plan B effectively functions like a high dose of birth-control pills. When taken within 72 hours following unprotected sex, the product reduces the risk of pregnancy by as much as 89%. Scientists believe the resulting surge of hormones interferes with ovulation and fertilization or may prevent implantation of a brand-new embryo in the uterus. The medical community generally doesn't consider this to be abortion, but some anti-abortion groups do. Plan B isn't the same as mifepristone, sometimes called RU-486, a pill that chemically induces an abortion.
The letter to Barr Pharmaceuticals Inc. (BRL), maker of the drug, was signed by Steven Galson, the head of the FDA's drug center and not a political appointee. For an approval letter to be signed by such a high-ranking official is unusual, but it reflects the unusual history of the Plan B application.
For the FDA, the decision will resolve a long-running question that has created tension within the agency, already under close congressional scrutiny over other issues. The original Plan B application had requested over-the-counter status for the drug, regardless of age. An FDA advisory committee voted in December 2003 to support that request. Memos that later leaked out showed the head of the agency's own office of new drugs, as well as other reviewers, agreed. But in May 2004, the FDA rejected the change, citing the lack of data about the youngest teens.
Barr, which had by then purchased rights to the drug from its original sponsor, then reapplied, requesting that women 16 and older be allowed to buy Plan B without a prescription. Last August, the FDA's then-commissioner, Lester Crawford, postponed a decision, saying the agency might need new regulations to enforce an age restriction. The agency's assistant commissioner for women's health, Susan Wood, resigned after that announcement, complaining that the FDA's handling of the drug hadn't been based on science.
But on July 31, the day before Dr. von Eschenbach was supposed to have a Senate confirmation hearing on his nomination, the FDA announced that it didn't need to craft a new regulation. In a memo, Dr. von Eschenbach said he concluded that 18 was the best cutoff age because it is a familiar one for states and pharmacies, which already enforce 18-and-older rules for products including nicotine patches. Dr. Galson said in his own memo that he now concurred with Dr. von Eschenbach that 18 was the appropriate dividing line.
The drug will be available only at licensed pharmacies and clinics, not gasoline service stations or convenience stores where no health-care professionals work. People who want to obtain it will have to show identification proving they are at least 18 years old. For those younger than 18, the drug will still require a prescription.
Barr also committed to a number of efforts to try to check that the age split is being enforced, including surveying health-care professionals and sending "anonymous shoppers" to test whether pharmacies are adhering to the rules. The company is also supposed to sponsor education efforts for health-care providers and consumers, and will provide a booklet to be distributed with the drug that will explain how it works and its proper use.
The new availability of Plan B is expected to sharply increase use of the product, which currently produces about $30 million a year in revenue for Barr. In France, after the introduction in 1999 of an emergency contraceptive pill available without a prescription, there was a 72% increase in its use over five years. In British Columbia, use of such medications increased by 102% after the Canadian province began allowing pharmacists to dispense them without a doctor's script.
The FDA's decision on the application, first filed in April 2003, may free up the stalled nomination of the agency's acting commissioner, Andrew von Eschenbach, to become the FDA's formal head. Two Democratic senators, Hillary Rodham Clinton of New York and Patty Murray of Washington, had placed a hold on the nomination until the agency resolved the long-delayed bid to offer Plan B over the counter.
Still, it is possible that other lawmakers could place holds for other reasons - including Dr. von Eschenbach's decision to allow Plan B to move to prescription-free status. And the FDA's decision, endorsed by President Bush in his press conference this week, will draw criticism and political heat from anti-abortion groups that have opposed more widespread availability of the drug. On the other side, reproductive rights groups will argue against the age restriction. Coming on the verge of an election, the issue could become far more politically prominent.
Other drugs in the pipeline at Drug Pipeline
No comments:
Post a Comment