AMA Criticized for Supporting OTC Sales of Morning After Pill
by Steven Ertelt
June 16, 2004
Washington, DC (LifeNews.com) — It didn’t take long for a decision by the American Medical Association, deriding the FDA for disapproving over-the-counter sales of the morning-after pill, to come under fire.
The AMA’s House of Delegates approved a resolution on Monday that said the Food and Drug Administration was wrong to have denied an application to sell the so-called morning after pill without a doctor’s visit.
The resolution passed without debate and had strong support during a committee meeting the day before.
Gail Quinn, director of the pro-life office of the nation’s Catholic Bishops, blamed the AMA for joining "abortion advocates in clamoring for morning-after pills to be available over-the-counter so that young women and girls will be able to obtain these drugs, whether or not they ‘need’ them, whether or not they might be contraindicated, and do so without even a doctor’s oversight."
In defending the AMA’s decision, Vivian Dickerson, president of the American College of Obstetricians and Gynecologists, said "the overwhelming data is that it is safe, effective and usable across age groups."
But Quinn says the drug’s manufacturer, Barr Laboratories, admitted to the FDA that there are no studies of the drug’s effect on adolescents.
In fact, the FDA 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.
"In other words, there is no data indicating it is [safe] despite ACOG’s assertion to the contrary," Quinn said.
"That a highly regarded medical association such as the AMA would attack the FDA for fulfilling its mandate — to put health interests over commercial interests … is as sad as it is appalling," Quinn added.
Quinn explained that Barr is estimated to make $25-$100 million on sales of the Plan B drug.
The drug is opposed by many in the pro-life community because it sometimes causes abortions and research on its effect on teens has been limited.
Despite the opposition, the FDA may grant Barr Labs the ability to sell the drug without a prescription to women 16 years of age or older.
After meeting earlier this month 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.
Galson made the original decision for the FDA in May to reject Barr’s application.