Articles
Can the FDA Rely on Political Issues for Product Approval?
Introduction
In the wake of multiple life-threatening episodes from faulty, unapproved drugs and devices, Congress has given the Food and Drug Administration (FDA) the responsibility of using generally accepted scientific principles and practice to approve products before commercialization.
Thus, FDA’s decisions are legally restricted to matters related to scientific considerations of available data. One of the few cases to go to court on this matter (Tummino v. von Eschenbach)1 was filed by the Center for Reproductive Rights in response to the FDA's refusal to grant full over-the-counter (OTC) status for Plan B, an emergency contraceptive—a decision which was seen as politically motivated rather than science-based. This lawsuit led to a 2009 court ruling by Judge Edward Korman, which noted that an internal FDA memo acknowledged that the clinic data before the agency “clearly supports” making Plan B available without a prescription “for all age groups,” and that such approval would be “consistent” with previous decisions on other products. A related FDA memo stated that the Agency had not previously “distinguished the safety and efficacy of Plan B and other forms of hormonal contraception among different ages of women,” and there was no “compelling scientific reason” for such a distinction in this case. The court stated that “Underlying all of these claims is plaintiffs’ allegation that the FDA’s decisions were made in bad faith because they were improperly influenced by political considerations wholly outside the scope of the FDA’s statutory authority.” By ignoring scientific facts, the court ruled that the FDA failed to follow its own procedures and statutory and regulatory mandates. Such action is considered “bad faith” and constitutes “arbitrary and capricious” decision-making which is illegal under the Administrative Procedures Act. Judge Korman explained the legal basis for such a finding as follows: “An agency decision may be deemed arbitrary and capricious: if the agency has relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.2 Moreover, “proof of subjective bad faith by [agency decision-makers], depriving a [petitioner] of fair and honest consideration of its proposal, generally constitutes arbitrary and capricious action.”3 An arbitrary and capricious action is illegal under the Administrative Procedures Act, which governs all executive agencies in the federal government.
In the current environment, there may be concern that the Agency would act under improper political influence rather than in accordance with its scientific expertise. To support legal claim of improper political influence, warranting finding of bad faith and consequent abuse of discretion under Administrative Procedure Act (APA), “there must be some showing that political pressure was intended to and did cause agency's action to be influenced by factors not relevant under controlling statute”.4 In the Tummino case, Judge Korman noted that there were multiple departures from FDA’s normal practices: i) a decision to act against strong scientific advisory committee recommendations, which had not been done in the OTC switch area for ten years, ii) unusual involvement of the Whie House in discussions about approval, iii) the timing of the decision to not approve OTC use for all ages before advice from Agency scientists had been received, and iv) the refusal to extrapolate evidence of safety from older age groups to younger age groups which was not consistent with how CDER handles approval and distribution of other contraceptives. In response, Judge Korman noted that the FDA argued “that there is no customary agency practice and “[e]very drug presents a unique collection of issues, and no two reviews will be identical.” But he noted that “Plaintiffs do not argue, however, that the scientific review or risk benefit assessment of all proposed OTC drugs must be evaluated in the same manner. They question why the review of Plan B differed in so many significant ways from the review of other switch applications in the last 10 years.”
For those involved with FDA regulatory review, this history is a helpful reminder of how courts have handled such matters in the past.
1 Tummino v. Torti, 603 F. Supp. 2d 519 (E.D.N.Y. 2009) [Von Eshenbach had been replaced as FDA Commissioner when the decision was handed down]
2 Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983); accord Yale-New Haven Hosp. v. Leavitt, 470 F.3d 71, 79 (2d Cir. 2006).
3 Latecoere Int’l, Inc. v. U.S. Dept. of Navy, 19 F.3d 1342, 1356 (11th Cir. 1994); James Madison Ltd. v. Ludwig, 82 F.3d 1085, 1096 (D.C. Cir. 1996)
4 5 U.S.C.A. § 706(2)(A)