Sunday, July 6th, 2008

Plan B approved for over-the-counter sale

Plan B, also known as the morning-after pill, is on its way to being sold without prescription to women 18 and older.

The U.S. Food and Drug Administration’s decision last Thursday to allow over-the-counter sale of Plan B has spurred opposition from some who say the easier access to the pill will promote unprotected sexual activity, and applause from others who say the new decision could lead to fewer unwanted pregnancies, especially among young women.

The FDA’s decision is not the final step in making Plan B available over the counter. Plan B has been available with a prescription since 1999.

“There has to have a system in place to ensure that the sale only occurs to those eligible. ... Anyone under age 18 will have to have a prescription, and a system is needed to monitor the program,” said Steven Kozel, pharmacy manager at the Arthur Ashe Student Health and Wellness Center at UCLA.

Plan B consists of two hormonal pills used to prevent pregnancy by preventing ovulation, fertilization or implantation of a fertilized ovum. If taken within 72 hours of having unprotected sex, Plan B can be up to 89 percent effective.

“Wider access is a step in the right direction,” said Ram Parvataneni, a UCLA assistant professor of obstetrics and gynecology. “(Selling Plan B over the counter) has potential to significantly reduce unwanted pregnancies.”

Plan B works differently from the abortion pill, RU-486, which terminates an existing pregnancy and is only administered with a prescription, Kozel said.

In the Aug. 24 approval letter, Dr. Steven Galson, director of the Center for Drug Evaluation and Research, outlined tasks that the company marketing Plan B, Duramed, agreed upon. This included establishing programs to enforce the age-based restriction. Individuals younger than 18 years old must have a prescription to obtain Plan B.

In the Convenient Access, Responsible Education program, Duramed, a subsidiary of Barr Pharmaceuticals, will provide consumers and health care professionals with labeling and education about the appropriate use of prescription and over-the-counter Plan B.

Among other duties, Duramed will also work to ensure that distribution of Plan B will only be through licensed drug wholesalers, retail operations with pharmacy services and clinics with licensed health care practitioners. Plan B will not be sold through convenience stores or other retail outlets in an effort to control its distribution and prevent its sale to younger women without a prescription.

“Leveraging well-established state and private-sector infrastructures will allow for comprehensive and effective enforcement of the age-based restrictions. ... This approach should help ensure safe and effective use of this product,” wrote Andrew C. Von Eschenbach, acting commissioner of the FDA in a memorandum on Aug. 23.

There have been concerns about widening access to the morning-after pill because some believe it may cause women to be less vigilant about using condoms, leading to an increase in the incidence of sexually transmitted diseases.

But Parvataneni said studies with more than 2,000 participants have shown that the availability of Plan B had no impact on the use of contraception or on sexual behavior.

Other people remain unsure of whether it will have a big impact on people’s behavior.

“A lot of it depends on how much it costs as an over-the-counter product, and how well educated the public is about it,” Kozel said.

Nevertheless, wider access will save consumers time crucially needed to prevent pregnancy.

“Selling Plan B over the counter can be really convenient because you can avoid an unnecessary wait,” said Jennifer Du, a UCLA psychology and political science student who graduated this year.

“Waits are expected at a federally funded clinic, which can put the girl in an unnecessary position, waiting up to three hours to get the prescription,” Du said. “Making it more convenient is helpful because females who seek out the morning-after pill are in a position where they are very stressed out, worried, anxious, and time is an issue.”

Comments

Post a comment

Username:
Password: (Forgotten your password?)

Comment:

Hollywood Park Summer 08 Button