BY OUR PHARMA CORRESPONDENT
31 August, 2005: The United States Food & Drug Administration has once again postponed the decision whether to allow the much-talked about morning-after pill-- Plan B-- selling without a prescription over the counter.
Federal drug regulators agency said though they are practically agreeing the pill to be sold over the counter to women above 17, they were not sure that the youngsters would not get access to the drug.
The agency will open a 60-day comment period for advice, said Lester M. Crawford, the commissioner of food and drugs, in a news conference.
The pill is manufactured by Barr Laboratories. In May 2004, the agency rejected a Barr application to sell Plan B over the counter without restrictions, saying the company's studies did not include enough girls younger than 16.
The agency approved Plan B as a prescription contraceptive in July 1999. The pill provides a concentrated dose of the medicines available in most daily birth control pills. It can prevent pregnancy if taken within 72 hours after sex, the agency said.
An agency advisory committee voted, 23 to 4, in December 2003 to approve the Barr application to sell the drug over the counter. Staff members at the agency also said the application should be approved. But the director of the agency's drug center announced in May 2004 that he had decided to override the advisory committee and the staff members and reject the application.
He said he feared that girls younger than 16 might engage in riskier sex if they knew that the morning-after pill was easily available. He noted that the study of 430 women by Barr on whether patients understood the drug's label had included very few girls younger than 16.
Barr then had to make a decision. It could have sponsored a study of young teenagers to prove that they understood how to take the drug correctly or it could apply to sell the drug over the counter only to women older than 16, the option it chose. Barr noted that the agency had already approved over-the-counter sales of nicotine gum only to people older than 18 and that cigarettes and alcohol were routinely sold with age restrictions.
Barr reapplied in July 2004, proposing to sell the drug over the counter only to women 16 and older and provide it by prescription to those younger than 16.
The agency has never allowed a drug to be sold simultaneously over the counter and by prescription with the same label and strength, Dr. Crawford said. More important, he added, the agency could not figure out how to enforce the age restrictions.
Some conservatives say the pill, viewed by the drug agency as a contraceptive, is really an abortion pill. Liberals respond that easier access to it would actually reduce the 800,000 abortions a year in the United States.
Seven states allow some over-the-counter access to morning-after pills. But the governors of Massachusetts and New York, both Republicans, recently vetoed bills to ease access in those states.
BY OUR PHARMA CORRESPONDENT