Forums > Social Discussion > Morning-After Pill

Quote:

---

Morning-After-Pill Ruling Defies Norm
By GARDINER HARRIS





top federal drug official said yesterday that he rejected not only the judgment of an advisory panel but also the recommendations of his own staff when he refused to allow a morning-after pill to be sold over the counter.


Dr. Steven Galson, acting director of the Food and Drug Administration's center for drug evaluation and research since October, acknowledged in an interview that his action was not the norm.


"I am not trying to convey this decision as being common or usual," Dr. Galson said.


The morning-after pill, called Plan B, is an emergency birth-control medicine that is currently sold only by prescription. Made of high-dose birth-control pills, it can interfere with ovulation and perhaps prevent a fertilized egg from being implanted if taken within 72 hours of unprotected sex.


The pill's maker, Barr Pharmaceuticals, hopes to sell it over the counter, a prospect that seemed likely in December when a federal advisory panel voted 23 to 4 to approve Barr's application. The agency normally follows the recommendations of its advisory panels, especially when their votes are overwhelming. Barr's hopes were raised even further when Dr. Galson's staff similarly recommended approval.


But on Thursday, the agency sent Barr a "nonapprovable" letter, saying it had rejected the company's application because it did not provide enough information about how young teenagers would be able to use the drug properly.


In interviews yesterday, several former F.D.A. officials said that they could not remember another instance in which Dr. Galson, a career officer in the public health service, or any of his predecessors had overruled both an advisory committee and staff recommendations.


"I can't ever remember the center director ever signing a nonapprovable letter," said Dr. Raymond Lipicky, who retired from a top agency position in 2002 after 18 years in the agency. "In my experience, that never happened." Such letters are invariably issued at a much lower level than the director.


Dr. Robert R. Fenichel, who left the agency in 2000 after 12 years, said, "This is simply unheard of."


Their comments came in the midst of a fierce debate about whether the agency's decision was based primarily in science or politics.


Dr. Galson said he knew of just a single instance in the past 10 years in which one of his predecessors had overruled the conclusions of those below him. "This isn't common, but it's not unheard of," he said.


Dr. Galson did not just disagree a little bit with his staff and the advisory board. If he had, he would have suggested that Barr receive an "approvable" letter for its application. Such a letter tells a company that it could receive approval if it provides certain additional information.


Despite its cheery name, such letters are not good news for companies, some of which have worked for years to develop and provide the information requested. Still, they are better than "nonapprovable" letters like the one Dr. Galson decided to send to Barr. Such letters suggest that approval is unlikely, companies say.


By sending a nonapprovable letter, Dr. Galson said in the interview, "We said that the shortcomings are so large that we are not able to go that intermediary step."


He said Barr had failed to prove that girls younger than 17 could use Plan B safely without the help of a physician, because the company's study included just 29 girls younger than 17 and none younger than 14. He said he worried that such girls might be more likely to have sex without condoms — exposing themselves to an increased risk of disease — if they had easier access to Plan B.


"The worse-case scenario is that you've got a young couple and they would normally use a condom when they were having intercourse, but since they know they can run to the CVS to get Plan B, are they going to worry about that?" he asked.


Conservative groups endorsed the action.


"This is a prudent decision to say that we must consider the consequences if teens use this drug as a means of birth control," said Tony Perkins, president of the Family Research Council, a conservative group.


But the agency's decision to take into account how some people might change their behavior because a drug is more available is also unprecedented, critics charge. Dr. Scott Spear of the Planned Parenthood Federation of America, noted that the agency was unlikely to ask the makers of anticholesterol pills if people would eat more cheeseburgers when their drugs became available over the counter.


"It's a bogus issue," Dr. Spear said. "They should be asking if the drug is safe and whether it's effective. That's it."


But Wendy Wright, senior policy director at Concerned Women for America, a conservative group, said the agency's questions were entirely appropriate. "One cheeseburger is not going to kill you, while risky sex can be life-threatening in one instance," she said.

---