FDA postpones over-the-counter access to emergency contraception

David Bellumori

For columnist Jen White’s take on contraception and birth control, please click here for her piece which ran in the Nov. 30 edition of The State Hornet.

DAVIS (U-WIRE) ?” The Food and Drug Administration has indefinitely postponed a request to bring emergency contraception, commonly known as the morning-after pill, to over-the-counter status.

The effort to make the morning-after pill as easily available as shampoo or condoms at the pharmacy has faced controversy throughout its campaign within the FDA in asking questions about what exactly dictates its decision-making process.

The Plan B medication, which works to prevent implantation, has been considered unique because it has elicited questions of morality as well as science to the American public.

The General Accountability Office, which serves as the investigative body of Congress, concluded through independent investigation that there were conflicting accounts within the FDA while making the decision. According to an outside news source, the FDA decision to deny the emergency contraception’s bid for over-the-counter status was made months before the scientific reviews were completed. There have also been reports of unusual involvement and activity by high-ranking agency officials.

While over-the-counter release of the drug is on hold nationally, students at the University of California-Davis currently have near over-the-counter access through Cowell Student Health Center. Michelle Famula, physician and director of the health center said she believes that, for UC Davis students, access to the drug is hassle-free.

Those who wish to have the drug on-hand in case of normal contraceptive failure can obtain it in the form of an advance prescription from the center. Students can also phone in requests to the nursing service and attend a regular office visit to obtain the drug.

Famula said the morning-after pill is a popular request among college students.

“We are probably averaging five to 10 requests for the medication per week through our nursing service,” Famula said in an e-mail interview.

California representative Henry Waxman (D-Los Angeles) referred to the decision as a “subversion of science.” Support for Waxman’s theory comes from a December 2003 decision by FDA scientific advisers that backed the over-the-counter release of the drug. Months later, that recommendation was rejected by FDA leadership, citing concern that young teens could begin to use the pills without the consultation of a doctor with an over-the-counter status change.

The morning-after pill is effective up to 72 hours after sex and is more effective the sooner it is taken. As time is of the essence with this drug, it is important that patients use it as soon as possible to ensure effectiveness.

According to proponents, the time required to make an appointment with the doctor and get a prescription filled can seriously inhibit, if not destroy, the usefulness of the drug. There is additional concern of reaching a physician’s office during the weekend or holidays.

Dennice Caldwell, assistant to Famula, said the health center pharmacy issued 542 prescriptions for the drug in 2004 and has so far issued 864 prescriptions in 2005.

“We seek to make this medication as available as possible to appropriate patients who select to use it,” Famula said.

One UC Davis undergraduate and user of the morning-after pill who wished to remain anonymous said she believes the decision by the FDA is a religious infringement on her personal rights.

“The only thing that the FDA is supposed to do is decide whether a drug is safe, not pass moral judgment on it,” she said.