Wisconsin Looks To Join Plan B Lawsuit Plaintiffs

Wisconsin Attorney General Peg Lautenschlager is seeking to join forces with the Center for Reproductive Rights in its lawsuit regarding FDA's handling of Barr Labs' Plan B Rx-to-OTC switch application.

Lautenschlager petitions to have the state of Wisconsin named as a plaintiff in the lawsuit in a March 15 Complaint of Intervening Plaintiff.

Wisconsin "challenges actions of FDA in not having switched, from prescription to over-the-counter status, emergency contraception pills known as Plan B," according to the complaint, which was filed in U.S. District Court for the Eastern District of New York.

The court is asked to "hold unlawful...actions of FDA in not having switched Plan B pills from prescription to OTC status." According to the filing, FDA's actions were arbitrary, capricious and "contrary to constitutional right, power, privilege, or immunity."

The CRR lawsuit, which also claims that the agency's actions were arbitrary and capricious, was originally filed in January 2005. The case also seeks to compel an agency decision on the switch, and is currently in the discovery phase.

Thus far, several decisions by the judge have been issued in favor of CRR. The court denied FDA's motion to dismiss the case, and will allow CRR to conduct depositions of high-level FDA officials such as former Commissioners Mark McClellan and Lester Crawford during discovery (¹ (Also see "FDA Topsiders Must Testify In Plan B Case – Judge" - Pink Sheet, 6 Mar, 2006.), p. 3).

CRR says it has requested documents from the government, and will begin scheduling the depositions once the materials have been received.

Lautenschlager announced in December that she was seeking approval from Governor Jim Doyle (D) to file the suit against FDA (² (Also see "FDA Plan B Review Warrants Lawsuit, Wisconsin Attorney General Says" - Pink Sheet, 12 Dec, 2005.), p. 3).

CRR does not know how likely it is that the court will grant the request and add the state as a plaintiff in the suit. One issue of concern for the court would be whether the addition would cause a delay, although CRR does not believe that would be the case.

The documents submitted by Lautenschlager detail the negative effects that prescription-only status for the emergency contraceptive have had on state residents. However, the allegations and prayer for relief in the CRR suit would remain unchanged in the event that Wisconsin is named a plaintiff, CRR said.

According to Lautenschlager's complaint, "Wisconsin, a sovereign State, has had, and will continue to have, substantial and concrete interest in assuring that each child born in Wisconsin is a wanted child."

Switching Plan B "would have significantly reduced unintended pregnancies, abortions and the birth of unwanted children among Wisconsin females capable of bearing children."

The complaint maintains that during 2000, 2001 and 2002, there were 332 births to Wisconsin females age 14 or younger and 7,220 births to those age 15-17.

"With so many pregnancies amongst Wisconsinites under 19 or younger being unintended...[the state] has compelling interests in removing any barricades to safe and effective methods through which Wisconsinites 19 or younger may choose to avoid pregnancies in Wisconsin," the complaint states.

Had FDA switched Plan B in August 2005, "larger increases in EC pill usage would have occurred than in the situations studied, where consumers still faced barriers to obtaining prescriptions from either their physicians or pharmacists," the complaint adds.

The consequences of witholding a decision on the Plan B application are "far reaching," Lautenschlager explained in a same-day press release.

The negative effects "hur[t] not only victims of rape who might be in need of emergency contraception, but the greater community health, the economy and the fundamental right to justice."

Separately, Plan B debate on Capitol Hill already has reignited following President Bush's March 15 nomination of Andrew von Eschenbach, PhD, to be permanent FDA commissioner (see ³ (Also see "Plan B Expected To Take Center Stage During Von Eschenbach Confirmation" - Pink Sheet, 20 Mar, 2006.)).

- Bridget Behling