MONDAY, July 31, 2006 (HealthDay News) -- In a surprise turnaround, U.S. health officials announced Monday that they are moving ahead with plans to make the so-called "morning-after pill" available over-the-counter to women 18 and older.
The U.S. Food and Drug Administration said it hoped to resolve "remaining policy issues" with Barr Pharmaceuticals, the company that makes the emergency contraceptive, within "a matter of weeks."
Monday's announcement came one day before Dr. Andrew von Eschenbach, President George Bush's nominee to head the FDA, was scheduled to testify before a Senate committee, where he was expected to face questions about the delay on approving the over-the-counter version of the drug, also known as "Plan B," the Associated Press reported.
When asked about the timing of the announcement, FDA spokeswoman Susan Bro said von Eschenbach wanted to spend more time at Tuesday's hearing on his plans for the agency, rather than the controversy surrounding Plan B, the news service reported.
FDA action on the controversial medication has been stalled for almost a year. Conservative groups worry the drug could lead to more premarital sex among teens.
Plan B is an extra high dose of regular birth control that needs to be taken within 72 hours of unprotected intercourse to be effective. Essentially, the drug prevents pregnancy by delaying ovulation. It does not interrupt an already implanted pregnancy.
The FDA originally approved Plan B as a prescription drug in 1999. In 2001, a group of more than 60 health groups petitioned the U.S. government to make emergency contraceptives available without a prescription, and, in December 2003, FDA advisors concluded that Plan B was both effective and safe. They overwhelmingly recommended the agency make Plan B available without a prescription.
In an unusual move, the FDA ignored the advice of the committee and, instead told Barr Pharmaceuticals it was delaying its decision.
Soon after, the FDA added another condition by informing Barr that the drug couldn't be sold over-the-counter until more studies were done. At the time, the FDA denied that the move was politically motivated but instead arose from concern that young teenage girls would not be able to use the product safely.
The pro-choice Center for Reproductive Rights has since sued the FDA to allow over-the-counter sales of Plan B, and this week subpoenaed White House e-mails and other documents on the matter.
While the FDA said it hoped to resolve the stalemate within a few weeks, outside experts were less sanguine.
"They're going to talk about trying to make plans to make that happen," said Dr. Michael F. Greene, director of obstetrics at Massachusetts General Hospital, and a member of one of the FDA advisory panels that voted in favor of the over-the-counter switch. "It seems as though nothing gets any attention from the [Bush] administration except political hardball and throwing a roadblock in the way of their nomination."
According to Greene, last summer, U.S. Health and Human Services secretary Mike Leavitt promised to Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.) a decision on Plan B by Sept. 1, 2005, if they released their hold on the nomination of Dr. Lester Crawford as FDA commissioner. The senators agreed, Crawford became FDA head for several months, and he deferred a decision on Plan B pending a period of public comment.
According to the Associated Press, Barr must now re-file its Plan B application with the following changes:
- The company must agree only to sell the drug over-the-counter to women over 18 (it had earlier sought to sell to women over 16).
- The nonprescription version must have completely different packaging from the prescription version and both must be kept behind a pharmacist's counter.
- Barr must outline how it will enforce the age restriction.
But critics like Greene were unwilling to take the stipulations at face value.
"The cynic might consider this as just another tactic to allow the von Eschenbach nomination to go through, only to wind up with inevitable and unending delays again," he said. "I don't believe anything until it happens, at this point. The history of this is very sad. It doesn't lead anyone to any optimism."
"As far as I'm concerned, the only opposition to this has to do with
either religious or philosophical or political objections," said Dr. Joseph Ramieri, chairman of the department of obstetrics and gynecology
at Atlantic Health, which operates several hospitals in New Jersey. "It's absolutely safe. It has a high efficacy rate and no known side effects other than possibly nausea. The other issues are not medical. They are social."
More information
The FDA has more on Plan B.
