FDA Plan B Review Warrants Lawsuit, Wisconsin Attorney General Says

Wisconsin Attorney General Peg Lautenschlager is seeking legal recourse against FDA for the agency's failure to issue a decision on Barr Labs' Plan B Rx-to-OTC switch application.

Lautenschlager requests permission to file a lawsuit against the agency in a recent letter to the state's Governor Jim Doyle (D). The governor's authority is required before the attorney general can file any federal lawsuit.

The letter also requests that the Wisconsin Department of Health & Family Services "further develop the facts as to how the FDA's politically motivated actions and inactions are affecting the health of Wisconsin women and the state's resources."

"The FDA's continued delay in approving Plan B as an OTC drug leaves individuals who have had unprotected sex, but who do not wish to conceive, with very limited options," Lautenschlager maintains.

"This could lead to unwanted pregnancies and births that may adversely affect Wisconsin residents and resources."

FDA announced in August that it would initiate an advanced notice of proposed rulemaking on dual-status drugs rather than issue a decision on Barr's supplemental NDA filed in July 2004. The application had proposed OTC sale of the drug for women age 16 and older and Rx sale for those 15 and younger.

The ongoing delay on the application has "serious legal consequences" because it violates the Administrative Procedures Act, according to the letter.

Specifically, Lautenschlager points to a recent report by the Government Accountability Office which deemed FDA's decision process on the switch "unusual" (¹ (Also see "FDA Disagrees With GAO’s “Unusual” Findings Regarding Plan B Decision" - Pink Sheet, 21 Nov, 2005.), p. 4).

The GAO report "supports the proposition that the process of denying Plan B OTC status was arbitrary and without observance of usual FDA procedure," Lautenschlager states.

A government agency is in violation of APA if its actions are arbitrary, capricious or without observance of procedure required by law, she notes.

The letter also points out that under the APA, a court shall "compel agency action [that is] unlawfully withheld or unreasonably delayed." According to Lautenschlager, initiation of the ANPR constitutes unreasonable delay.

Lautenschlager's office anticipates that the governor's decision will come before the end of the calendar year.

However, even if the lawsuit is authorized, it will not be filed immediately. The office will first work with the Department of Health & Family Services to determine what findings should be included in the complaint.

Costs would be included in the analysis that the Department would conduct, though Lautenschlager's office acknowledged that an exact dollar figure would be difficult to generate.

Although Lautenschlager does not know what the governor's response will be, her office pointed out that Doyle "has been concerned" about the Plan B decision delay in general.

Lautenschlager is described as a "long-time advocate of contraceptive equity and reproductive rights" in a press release from her office.

For example, she authored an opinion in August 2004 at the request of the Department of Health & Family Services on the exclusion of contraceptives from an employer-, college- or university-sponsored benefits programs.

In the opinion, Lautenschlager stated that excluding contraceptives from such programs that otherwise provide Rx drug coverage violates the state's law prohibiting sex discrimination.

Wisconsin appears to be the first state claiming that FDA inaction on the application is harming public health. However, FDA already is facing one lawsuit related to its handling of Plan B.

The Center for Reproductive Rights (CRR) filed a suit in January stating that FDA's May 2004 decision to deny Barr's original switch NDA was "arbitrary and capricious" (² (Also see "FDA Memo Sheds Light On Plan B Discussions" - Pink Sheet, 31 Jan, 2005.), p. 7).

The original application sought OTC approval without an age restriction.

Oral arguments for the lawsuit filed by CRR are scheduled for Dec. 20.

- Bridget Behling