District Court Dismisses PLAN B Case Against FDA Based on Lack of Standing and Failure to Exhaust Administrative Remedies

March 10, 2008

In April 2007, we reported on a complaint filed by a group of non-profit organizations (including the Association of American Physicians & Surgeons, Concerned Women for America, Family Research Council, and Safe Drugs For Women) against FDA (and later Duramed Pharmaceuticals, Inc.) in the U.S. District Court for the District of Columbia requesting that the court, among other things, vacate FDA’s August 24, 2006 approval of a supplemental NDA (“sNDA”) for Duramed’s emergency contraceptive PLAN B (levonorgestrel) Tablets, 0.75mg.  FDA’s August 24, 2006 approval permitted Over-the-Counter (“OTC”) use of PLAN B in women 18 years and older and maintained prescription status for women 17 years old and younger. 

After FDA and Duramed filed motions to dismiss the case based primarily on a lack of standing, the Plaintiffs amended their complaint in an attempt to cure any deficiencies.  The amended complaint includes 8 counts:

(1) that the FDA’s approval was unlawful because the SNDA failed to demonstrate that Plan B was safe for OTC use by consumers age 18 and older;

(2) that the FDA’s approval violated the [Federal Food, Drug and Cosmetic Act (“FDCA”)] by allowing Plan B to be marketed as both a prescription and an OTC drug;

(3) that the FDA’s age-based decision violated the FDCA;

(4) that the FDA has created a “third class” of drugs in violation of the FDCA;

(5) that the FDA violated the [Administrative Procedure Act (“APA”)] by failing to conduct a rulemaking;

(6) that the FDA violated the FDCA by failing to conduct a rulemaking;

(7) that the [FDA was] improperly influenced by political pressure; and

(8) that the FDA is not authorized to impose administrative exhaustion requirements.

FDA and Duramed filed motions to dismiss the amended complaint (available here and here) arguing that the Plaintiffs lacked standing to bring any claim and that that they failed to exhaust their administrative remedies, and objecting to the Plaintiffs’ legal theories with respect to counts 2, 4, 5, and 6 of the amended complaint.  “Although plaintiffs have alleged numerous standing theories on behalf of women, physicians, and pharmacists within their membership, and the organizations themselves, their allegations are insufficient to establish the elements of standing on behalf of any of these subgroups or individuals,” states FDA’s memorandum in support of the Agency’s motion to dismiss. “Similarly, plaintiffs have failed to allege a cause of action within the Court’s jurisdiction.  There is no right under the FDCA or APA for members of the general public to challenge or participate in a drug application proceeding.  Plaintiffs have also failed to exhaust administrative remedies as required by FDA regulations . . . .”

On March 4, 2008, Judge John Bates granted FDA’s/Duramed’s motion to dismiss.  In the memorandum opinion accompanying the dismissal order, Judge Bates ruled that the court has no jurisdiction to entertain the amended complaint because of the plaintiffs’ lack of standing to assert the claims in the complaint, and because the plaintiffs also failed to exhaust their administrative remedies, thereby further rendering the action nonjusticiable. 

With respect to standing, the plaintiffs challenging FDA articulated a representational standing argument in their court papers based on several alleged injuries flowing from FDA’s August 24, 2006 PLAN B approval.  The court did not buy the argument and stated that “Plaintiffs have failed to establish standing because they lack a sufficient personal stake in the outcome of the litigation so as to warrant the invocation of federal-court jurisdiction.” 

On the issue of failure to exhaust administrative remedies raised by FDA and Duramed in their motions to dismiss, the court noted that “[t]his threshold issue presents a more difficult question.”  The plaintiffs argued in their court papers, among other things, that 21 C.F.R. § 10.45(e), which permits “interested persons” to, under certain circumstances, “request judicial review of a final decision of the [FDA] Commissioner in the courts without first petitioning the Commissioner for reconsideration or for a stay of action,” allowed them to proceed to court without first presenting their arguments to FDA, because the Agency’s PLAN B sNDA approval was final agency action.  The court ultimately disagreed: “Although plaintiffs’ interpretation of the regulatory requirements has some surface appeal, it would allow ‘interested parties’ to bypass the administrative remedies and would undermine the entire regulatory process” (internal quotations omitted).

It is unclear whether the organizations challenging FDA’s PLAN B approval will appeal the district court decision or will first exhaust their administrative remedies at FDA – or perhaps abandon all hope of vacating the PLAN B approval.  Stay tuned!

By Kurt R. Karst    

Categories: Drug Development