Congressman: "Morning After" Pill Likely to Get OTC Approval From FDA
by Steven Ertelt
June 9, 2004
Washington, DC (LifeNews.com) — After meeting with a top FDA official, a Congressman says the Food and Drug Administration is likely to reverse its initial decision prohibiting over-the-counter sales of the so-called morning after pill.
After meeting last week with Steven Galson, acting director of FDA’s Center for Drug Evaluation and Research, pro-abortion Rep. Jim Greenwood, a Pennsylvania Republican, says he is "very confident" that the FDA will reverse its decision later this year.
If so, Barr Laboratories, maker of the Plan B drug, will be able to sell the pills without a prescription.
Pro-life groups and many members of Congress opposed the sale of the drug to teenagers and without a physician’s consultation. They say it can sometimes work as an abortion drug by preventing the unborn child from implanting into the mother’s uterus.
On May 6, the FDA denied Barr’s request, in part because the pharmaceutical company failed to provide enough data about the impact of the drug on teens.
The agency said Barr’s main basis for approval was a study of 585 people who had used the drug. However, the FDA pointed out that only 29 of the subjects were 14-16 years old.
Pro-life organizations celebrated the decision and some forty-nine House lawmakers, led by Rep. Dave Weldon (R-FL), urged President Bush in January to reject Barr’s application.
But Greenwood, who called the decision "horrible," met with Galson on June 2 with the intention of "reading him the riot act," the Congressman told The Hill newspaper.
Greenwood said he was surprised to learn the FDA is reconsidering its decision.
"Galson didn’t give me a guarantee, but he conveyed to me that the product would be approved," Greenwood told the Capitol Hill newspaper.
Carol Cox, spokeswoman for Barr Pharmaceuticals, said her company was hopeful the FDA would follow through on its promise to review a new application for over-the-counter sales, but she didn’t expect the agency to approve a new application this year.
Barr is expected to ask the FDA to approve OTC sales of the drug only for women 16 years or older, in response to FDA complaints that the company didn’t show how the drug affected younger teens.
"Whether or not Representative Greenwood feels confident that the FDA may make Plan B available to high-school children over the counter, I stand firm in my conviction that this risky scheme will fuel a rise in sexually-transmitted diseases amongst our teens and jeopardize their health and futures," Weldon told The Hill.
"What confidence do we have that a 16-year-old will not buy the drug over the counter and then hand it to a 12-, 13- or 14-year-old? This policy would be irresponsible," Weldon, also a doctor, added.
The agency’s decision was atypical because it disagreed with the recommendation of an advisory panel that voted 23-4 in December in favor of sales with a prescription.
Also, Galson said he made the decision himself to deny the application over the objections of the panel and other FDA staff.
"A drug which can destroy human embryos and increases health risks to women and girls does not belong on the drugstore shelf," Cathy Cleaver Ruse, of the United States Conference of Catholic Bishops, said, after the FDA’s decision.
Ruse said the morning after pill has been associated with a heightened risk of ectopic pregnancy, a potentially fatal condition. Medical authorities in the U.K. and New Zealand have issued warnings about the drug’s dangers.