FDA Delays Decision on Revised Application for Over-the-Counter Plan B
Barr Laboratories -- which manufactures the emergency contraceptive Plan B -- on Friday announced that FDA is delaying a decision on the company's revised application to allow the pills to be sold over the counter to women ages 17 and older but to require a doctor's prescription for women ages 16 and younger, the AP/Las Vegas Sun reports (AP/Las Vegas Sun, 1/21).
In response to the original Plan B application from Barr, FDA in May 2004 issued a "not approvable" letter, which cited inadequate data on the use of the pills among girls ages 16 and younger. The FDA decision contradicted the recommendations of two agency advisory panels that in December 2003 voted 23-4 to recommend approval of the sale of Plan B without a prescription. Steven Galson, acting director of the FDA Center for Drug Evaluation and Research, said that he made the decision to not approve the application on his own and did not follow the recommendations of his staff.
FDA scientists disagreed with the agency's finding that there was not enough information on how Plan B would affect the sexual behavior of younger women, and a study published in the Jan. 5 issue of the Journal of the American Medical Association found that women who have ready access to EC are no more likely to engage in unprotected sex or abandon use of other contraception methods than women who do not have easy access to the pills (California Healthline, 1/5).
According to a Barr release, Friday was the deadline for FDA to render a decision on the application under the Prescription Drug User Fee Act. Barr said that FDA "indicated" to the company that "the agency is committed to completing its review of the application in the near future," and Barr "remains optimistic" that the agency will approve Plan B for OTC sale (Barr release, 1/21).
The Center for Reproductive Rights, only "[h]ours" after Barr announced the delay in the application, filed a lawsuit against FDA in a U.S. District Court in New York, claiming that the agency "did not follow its own procedures or statutory and regulatory mandates when it first denied the application," according to the AP/Sun (AP/Las Vegas Sun, 1/21).
The group filed the lawsuit on behalf of the Association of Reproductive Health Professionals, the National Latina Institute for Reproductive Health and others, according to a CRR release.
"Half of the three million pregnancies in the U.S. are unintended each year. By denying women over-the-counter access to a safe and effective drug that would significantly reduce those numbers -- including pregnancies that end in abortion -- the FDA is acting unlawfully and ignoring its mandate to advance the public health," Nancy Northup, president of CRR, said (CRR release, 1/21).
"We're glad that the FDA is taking a very hard look at this," Wendy Wright, senior policy director for Concerned Women for America -- which opposes Barr's request -- said (Richwine, Reuters, 1/21).
However, Nancy Keenan, president of NARAL Pro-Choice America, said, "I certainly hope FDA's decision isn't motivated by political considerations" in advance of the annual March for Life antiabortion protest in Washington, D.C., which is scheduled for Monday (AP/Las Vegas Sun, 1/21).