FDA Over-the-Counter Plan B Sales OK Near

The Food and Drug Administration moved toward allowing adult women to buy the emergency contraceptive Plan B without a prescription, a step that would resolve a politically charged issue that sparked intense debate inside and outside the agency.

Yesterday's announcement, in a letter to Plan B manufacturer Barr Pharmaceuticals Inc., came just a day before the agency's acting commissioner, Andrew von Eschenbach, was set to appear at a Senate confirmation hearing on his nomination to become the FDA's formal leader. The FDA's handling of the application to offer Plan B without a prescription, which was first filed in March 2002, has become a major stumbling block in efforts to confirm a commissioner.

Two Democratic members of the Senate committee that oversees the FDA, Hillary Rodham Clinton of New York and Patty Murray of Washington, said that they hadn't changed their plan to block Dr. von Eschenbach's nomination from proceeding, because the FDA has still not taken final action on Plan B. Sen. Murray said the agency had issued a "nondecision," and Sen. Clinton said the delay was a "dangerous precedent."

The FDA said it is "committed to working diligently through" the remaining issues with the application and it hopes the process can be wrapped up "in a matter of weeks." A spokeswoman said Dr. von Eschenbach "wanted to provide a thoughtful approach to resolving what has been one of the most divisive issues the agency has faced, specifically so he can focus on his broad and ambitious vision for" the FDA.

In the letter, the agency said it believed that "the appropriate age" for over-the-counter access to Plan B is 18 and older because of "enforcement considerations" and Barr would need to amend its latest application, which was for females 16 and older, to focus on adult women. Barr will also have to change its proposed packaging, the agency said. The company and the FDA spokeswoman said they expected that Barr would meet with FDA officials in the next week to discuss the issues. The letter also said that if Barr can't prove to the FDA that its program would prevent young girls from getting the drug, the agency might still leave the contraceptive available only with a prescription.

Bruce Downey, Barr's chief executive, said he was pleased but "the proof will be in the outcome." He said he believes the Woodcliff Lake, N.J., company's proposed program "provides adequate safeguards." He said he still believes the drug should be available to women of all ages, as the original Plan B over-the-counter application requested.

The letter was signed by Dr. von Eschenbach himself, a mark of the unusual nature of the agency's handling of Plan B. The FDA said last year that reviewers at its drug center had found that it would be safe to offer the pills without a prescription to patients 17 and older.

Former Commissioner Lester Crawford last August announced that the Plan B application needed further review because of regulatory challenges tied to the age split, and the FDA requested public comment. 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.

The agency said yesterday that most of those who filed comments felt it didn't need to do a formal rule making, a regulatory process that often takes years. Plan B has been a political lightning rod for broader debates over abortion, teenage sexual activity and the role of politics in science. Antiabortion groups have lobbied against allowing easy access to Plan B, saying it could encourage teenage promiscuity and higher rates of sexually transmitted diseases.

Barr pharmaceutical pipeline and competitive drugs in development are at www.chartsbank.com/PipelineList.aspx