HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

A Member of the Law Professor Blogs Network

Wednesday, March 25, 2009

FDA Must Reconsider Plan B Rules For Young Women

The Washington Post has a good story on the federal district court decision on the morning-after pill and the FDA's decision in 2006 to refuse to permit young women below the age of 18 access to it.  Rob Stein writes,

A federal judge ordered the Food and Drug Administration yesterday to reconsider its 2006 decision to deny girls younger than 18 access to the morning-after pill Plan B without a prescription. U.S. District Judge Edward R. Korman in New York instructed the agency to make Plan B available to 17-year-olds within 30 days and to review whether to make the emergency contraceptive available to all ages without a doctor's order.

In his 52-page decision, Korman repeatedly criticized the FDA's handling of the issue, agreeing with allegations in a lawsuit that the decision was "arbitrary and capricious" and influenced by "political and ideological" considerations imposed by the Bush administration."These political considerations, delays and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned agency decision-making," he wrote. "Indeed, the record is clear that the FDA's course of conduct regarding Plan B departed in significant ways from the agency's normal procedures regarding similar applications to switch a drug from prescription to non-prescription use."  FDA lawyers are reviewing the decision, said Rita Chappelle, an agency spokeswoman, who declined to comment further.

Critics of the FDA's decision hailed the ruling. "We're very excited," said Suzanne Novak, a senior staff lawyer for the Center for Reproductive Rights, which filed the lawsuit. "The message is clear: The FDA has to put science first and leave politics at the door."

Opponents of Plan B condemned the judge's order. "This ruling puts politics above women's health, and intrudes into parents' ability to protect their minor daughters," said Wendy Wright of the group Concerned Women for America. She also questioned the drug's effectiveness. . . .

In his ruling, Korman detailed repeated interference by "political actors" in the agency's handling of Plan B, including the long delay in approving the drug and the ultimate decision to act only after some senators tried to apply pressure by blocking confirmation of acting FDA commissioners. The agency's justification for its final decision "lacks all credibility," Korman said. . . . 

Susan F. Wood of George Washington University, who resigned from the FDA because of the agency's delays, noted that several officials involved in the decision are either still at the agency or in other key government positions, including Janet Woodcock, who heads the FDA's drug approval office, and Steven Galson, now acting surgeon general and assistant secretary of health. But Wood and others said they are confident that the new leadership at the agency will make Plan B widely available after reviewing the case.

"I think FDA is now in a position where it can make a fair decision because of the change in leadership and the commitment by everyone involved to make science-based decisions," Wood said. "This is a chance for the agency to demonstrate it is back on track."

President Obama recently announced plans to name former New York City health commissioner Margaret A. Hamburg as FDA commissioner and Baltimore Health Commissioner Joshua M. Sharfstein as her deputy. He also issued an order he said was designed to insulate scientific decisions throughout the government from political influence. . . .

http://lawprofessors.typepad.com/healthlawprof_blog/2009/03/fda-must-reconsider-plan-b-decision-for-young-women.html

| Permalink

TrackBack URL for this entry:

http://www.typepad.com/services/trackback/6a00d8341bfae553ef01156e4fbb57970c

Listed below are links to weblogs that reference FDA Must Reconsider Plan B Rules For Young Women:

Comments

Post a comment