Maker of Morning-After Pill Ready for Over-the-Counter Studies
Feb. 14, 2001 -- The next step in making a morning-after pill available over the counter in the U.S. is about to begin.
Executives at Women's Capital Corporation, maker of the Plan B emergency contraceptive pill, say the FDA-sanctioned studies are gearing up in Washington state and California.
In the trials, 450 women will be allowed to get Plan B, without a prescription, from specially designated Washington state pharmacies. The objective is to see if the women use the pills properly and to determine how many still get pregnant, said Sharon Camp, PhD, the drug company's president.
Another study, at an outpatient clinic at the University of California at San Francisco, will determine the effectiveness of allowing 1,000 young and low-income women to keep packets of Plan B at home in case of emergency. Researchers also will assess if easy access has a down side, such as persuading women to drop regular contraception, Camp said.
Earlier this month, Women's Capital Corporation sought help from federal regulators in designing its studies. At the time of the meetings, Camp said she was confident her company would be able to provide the FDA with data showing Plan B is appropriate for over-the-counter use.
She said that the FDA suggested many study modifications and that, once studies began, the company would try to submit a change-of-status application by the end of this year. If these goals are met, it is possible that an over-the-counter version of Plan B would be available sometime in 2002.
On Wednesday, 60 medical and women's groups filed a petition with the FDA, declaring that morning-after pills are as safe as aspirin and urging they be sold without a prescription to help women prevent pregnancy. Women's advocates say wider emergency contraception use could prevent 1.7 million unplanned pregnancies and hundreds of thousands of abortions. They want it sold over the counter because some women haven't been able to obtain a prescription in time.
The American Medical Association supports the change, already made in Britain last month following several other European nations.
As the drug manufacturer met with the FDA, some experts said they were pleased the drug could become available without a prescription. But some questioned the need for more research before the change of status is authorized.
"The FDA has enough information right now, and they have the legal authority to make the switch to OTC without requesting any further information," said David Grimes, MD, vice president of biomedical affairs for Family Health International in Research Triangle Park, N.C.
Plan B, Grimes said, as well as the combination progestin and estradiol drug Preven, are both safe enough for women to get over-the-counter if they need emergency contraception.