Suit Sought on Pills; FDA Called Slow on OK of Morning-After Drug
Posted on: Friday, 2 December 2005, 15:00 CST
By STACY FORSTER
Madison State Attorney General Peg Lautenschlager today asked Gov. Jim Doyle to give her authority to sue the U.S. Food and Drug Administration for delaying approval of over-the-counter sales for emergency contraception.
Lautenschlager said the agency has played political games with the drug and hasn't followed traditional protocol in deciding whether it should be sold without a prescription.
"This is something that should have been handled in a way that's standard and that's done based on scientific and medical research and not the political whims of the day," Lautenschlager said.
Sometimes known as the "morning-after pill," emergency contraception is a higher dose of regular hormonal contraceptive available with a doctor's prescription. Taking the drug within the first 72 hours after having unprotected sex can reduce the chances of pregnancy.
In August, the FDA declined for a second time to give approval to Barr Laboratories Inc. to sell "Plan B" medication over the counter to women over age 16, saying that regulatory and policy issues with the drug still needed to be resolved. FDA spokeswoman Susan Cruzan said the agency had asked for public comment on the drug; the period for commenting ended Nov. 1 and that input is being reviewed.
Cruzan declined to comment on the possibility of a lawsuit over the issue.
A November General Accounting Office report found that the FDA's handling of the decision was not typical, but the FDA disputed that conclusion.
Marc Tuttle, spokesman for Pro-Life Wisconsin, said the agency should take a longer time making a decision because Plan B differs from a traditional drug, as it isn't taken to restore or improve health. Some abortion opponents, including Tuttle, also consider its effect to be a chemical abortion, as it may prevent a fertilized egg from implanting in a woman's uterus.
Doyle was holding hearings on gas prices in Milwaukee Thursday and hadn't seen Lautenschlager's letter.
Doyle spokeswoman Melanie Fonder said he would carefully review the request before making a decision, but she added that he, too, is concerned about the FDA's delay.
The state Department of Health and Family Services will work with the Department of Justice to see if the state should proceed with a lawsuit, Fonder said.
The state constitution requires Lautenschlager to get permission from the governor or one house of the Legislature to bring such a lawsuit.
Copyright 2005, Journal Sentinel Inc. All rights reserved. (Note: This notice does not apply to those news items already copyrighted and received through wire services or other media.)
Source: Milwaukee Journal Sentinel
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