Sebelius Plans To Leave Plan B Decision To Science

Doctors and scientists, not politicians, must evaluate the safety of the emergency contraceptive Plan B , says Kathleen Sebelius, the Department of Health and Human Services secretary nominee.

FDA will review the drug's safety, as ordered by a federal court, the Kansas governor said in written responses to questions from Senate Finance Committee members made available April 9.

Sebelius declined to take a position on whether Plan B should be available without a prescription to women under the age of 18.

"Doctors and scientists will provide us guidance on who can safely and appropriately use Plan B," Sebelius wrote in response to Nevada Republican Sen. John Ensign's question about whether Plan B should be available to minors OTC.

"It is important to emphasize that this is a highly sensitive issue involving our families and our values," but "parents need to teach their children to act responsibly" to limit the number of unintended pregnancies and abortions, she added.

The Senate Finance Committee is scheduled to vote on her confirmation April 21, following Congress' return from the spring recess.

In March, the U.S. District Court for the Eastern District of New York ordered FDA to allow Plan B sales to 17-year-olds without a prescription. The ruling, which criticized FDA's handling of Barr Labs' Plan B switch, also ordered the agency to reexamine a citizen petition requesting universal OTC availability of Plan B (¹ (Also see "Plan B Ruling: Little Commercial Impact, Big Policy Implications" - Pink Sheet, 30 Mar, 2009.), p. 3).

The ruling endorses the view that the Bush administration pressured FDA during the Plan B review process. A group of agency staffers recently suggested President Obama remove FDA leaders whose work on the Plan B switch was tainted by political influence (² (Also see "FDA Scientists Say Plan B Decision-Makers At CDER “Should Be Removed”" - Pink Sheet, 6 Apr, 2009.), p. 3).

Suzanne Novak, senior staff attorney at the Center for Reproductive Rights, noted Sebelius recognized the district court's finding that FDA failed by allowing political influence to interfere with the safety assessment of a drug.

"We're confident that, after reviewing the prior assessments made by its own scientific experts, the FDA will determine that Plan B should be made available without a prescription to all age groups," she said in an e-mail.

However, Concerned Women for America President Wendy Wright said Sebelius is overlooking the fact that Plan B is available without a prescription while Rx birth control pills contain a lower dose of the same active ingredient, levonorgestrel.

Additionally, Wright said, research shows Plan B is ineffective for reducing pregnancies and abortions.

"Even a judge's opinion can't change the fact that giving women a false impression about a drug's effectiveness forces the FDA to become snake oil salesmen," she said in an e-mail.

Food and drug attorney Kurt Karst, of Washington-based Hyman, Phelps & McNamara, said he expects the agency would appeal the Plan B ruling only to erase the precedent of a court vacating an FDA scientific determination, not on the grounds of the decision (³ (Also see "Plan B Ruling Sets A Precedent That Could Give FDA Pause" - Pink Sheet, 30 Mar, 2009.), p. 6).

Watching Over Whistleblowers

Sebelius clarified her interest in protecting HHS whistleblowers and her preference to resolve departmental disagreements internally.

A question posed by Sen. Chuck Grassley, the Finance Committee's ranking member, asked Sebelius how she would ensure protection for FDA, CDC and NIH whistleblowers and that their claims are investigated seriously.

The FDA staffers who called for the removal of the Plan B decision-makers also asked the Iowa Republican to bring to Sebelius' attention their concerns about political taint and retaliation against agency whistleblowers.

The HHS nominee wrote she would address whistleblower issues through a "department-wide effort on scientific integrity" and require each agency to have clear rules to protect whistleblowers and investigate their allegations.

Sebelius added that she does not intend to isolate HHS scientists from all outside influence. She referred to her goal of encouraging scientists' interests and avoiding conflicts in their collaborations with the private sector and academia.

Portrait Of A Secretary-Designate

Sebelius responded to numerous questions about the future of health care coverage, health and wellness initiatives and food and drug safety.

Her responses show she is firmly in line with the health care reform agenda proposed by President Obama, for whom Sebelius was mentioned as a potential running mate during the campaign.

She wrote of creating a national health insurance exchange, through which individuals could choose public or private coverage options and insurers would compete based on cost and quality of care.

Sebelius also intends to cut overall health care spending by taking "a leadership role in educating the public to adopt healthy lifestyle practices." This would include improved access to smoking-cessation services and a school-based emphasis on nutrition.

With regard to food, drugs and devices, FDA needs to improve identifying and preventing safety issues - an area in which the agency "has not performed as well as it should in recent years," she wrote.

The agency also must adopt a risk-based approach to conduct inspections of foreign food and drug facilities, Sebelius added. This includes establishing dedicated inspectorates for specific regulated products and working more closely with foreign governments.

Sebelius opposes splitting FDA in two separate agencies for food and for drugs and devices, she said during her March confirmation hearing before the Senate Health, Education, Labor and Pensions Committee. She called the idea "premature" and said oversight of the food supply chain should be bolstered under the existing system (⁴ (Also see "HHS Nominee Sebelius Aims To Restore Science-based Approach At FDA" - Pink Sheet, 6 Apr, 2009.), p. 10).

- Dan Schiff ([email protected])