N.Y. Federal Judge Overturns FDA Regulation on Sales of Plan B Contraceptive

A New York federal judge has ordered the Food and Drug Administration to allow the manufacturers of Plan B to make the emergency contraceptive available to 17-year-olds without a prescription. The judge also ordered the FDA to reconsider whether adolescents younger than 17 should be able to purchase the drug over the counter. The FDA's decisions limiting access to the drug were tainted by improper political influence and departures from the agency's own policies, the judge wrote.

Mark Fass

New York Law Journal

2009-03-24 12:00:00 AM

A federal judge in Brooklyn, N.Y., has ordered the Food and Drug Administration to allow the manufacturers of Plan B to make the emergency contraceptive available to 17-year-olds without a prescription.

Eastern District of New York Judge Edward R. Korman also ordered the FDA to reconsider whether adolescents younger than 17 should be able to purchase the drug over the counter, as adult women have been able to do since 2006.

The FDA's decisions limiting access to the drug were tainted by improper political influence and departures from the agency's own policies, Korman wrote.

"Plaintiffs have presented unrebutted evidence of the FDA's lack of good faith," he said in his 52-page decision, Tummino v. Torti, 05-CV-366.

"This lack of good faith is evidenced by, among other things, (1) repeated and unreasonable delays, pressure emanating from the White House, and the obvious connection between the confirmation process of two FDA Commissioners and the timing of the FDA's decisions; and (2) significant departures from the FDA's normal procedures and policies in the review of the Plan B switch applications."

Plan B, a synthetic hormone that blocks unwanted pregnancy when taken within 72 hours of sexual intercourse, was approved for prescription-only use in July 1999. In 2006, the agency approved the switch to over-the-counter use for women 18 and older.

The drug, which has no known serious or long-term side effects, is available without prescription "in much of the world, including virtually all major industrialized" countries, according to Monday's decision.

The present action dates back to 2001, when 66 organizations, including the Association of Reproductive Health Professionals (ARHP), filed a so-called "Citizen Petition" requesting that the FDA convert Plan B, and all emergency contraceptives, from prescription-only to over-the-counter status, with no age or point-of-sale restrictions.

The drug's original manufacturer, the Women's Capital Corporation, also filed a number of applications seeking liberalized access to the drug.

Those applications and the petition received much support from scientists at the FDA, who found the drug to be "safe and effective" with a "low misuse and abuse potential."

Nonetheless, in May 2004, the then-acting FDA commissioner, Janet Woodcock, denied Women's Capital's application, citing among other factors a purported lack of data supporting appropriate use of Plan B by adolescents under 16.

In 2005, it was widely reported in the news that Woodcock issued a staff memo forecasting a world in which the approval of Plan B would lead to teen "sex-based cults" centered around use of the drug.

And in June 2006, the FDA, headed by another acting commissioner, Andrew von Eschenbach (who would soon be ratified as commissioner), denied the petition, again finding insufficient data regarding a switch to over-the-counter status.

In January 2005, the plaintiffs -- advocates of emergency contraception, including ARHP, one of the signers of the petition -- initiated the present action, challenging among other things the denial of the Women's Capital application and the delays in deciding (and, later, the rejection of) the petition.

The plaintiffs contended that the FDA's inaction and rejections were the product of bad-faith decision-making, and therefore could be vacated under the Administrative Procedure Act.

They cited numerous examples of the agency's lack of good faith and reasoned decision-making, including evidence that the FDA was pressured by the Bush administration to block access to the drug and that the agency departed from its own policies in about a half-dozen ways, including acting against its own advisory committee's recommendation and allowing an unusual degree of involvement by the White House.

"Plaintiffs are right," Judge Korman decided. "The FDA repeatedly and unreasonably delayed issuing a decision on Plan B for suspect reasons ... . These political considerations, delays, and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned agency decision-making."

He concluded, "The record is clear: the FDA's justification for the denial of [over-the-counter] access to Plan B for women over the age of 17 -- rather than 18 -- 'runs counter to the evidence' and 'is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.'"

The court gave the FDA 30 days to permit Barr Pharmaceuticals, the Plan B drug sponsor, to make the drug available to 17-year-olds without a prescription.

AGENCY'S EXPERTISE

However, deeming the decision as to whether the drug could safely be used without a prescription by girls as young as 11 or 12 "best left to the expertise of the FDA, to which Congress has entrusted this responsibility [rather than] a federal district court judge," Korman remanded to the agency the issue of whether to switch the drug to over-the-counter status for that population.

In deciding to return the matter to the FDA, Korman also cited the country's recent change of presidents.

"Commissioner von Eschenbach has resigned and his replacement, as well as a new Deputy Commissioner, has been nominated by the President," Korman wrote. "This change in the leadership suggests that, in plaintiffs' words, it can be 'trusted to conduct a fair assessment of the scientific evidence.'"

The court's electronic records list 19 pages of attorneys in the matter.

F. Franklin Amanat served as lead counsel for the U.S. Attorney's Office for the Eastern District. An office spokesman said the decision is under review.

Suzanne Ilene Novak and Janet Crepps of the Center for Reproductive Rights served as lead counsel for the plaintiffs.

In a statement Monday, the center's president, Nancy Northup, said, "Today's ruling is a tremendous victory for all Americans who expect the government to safeguard their health not undermine it. The court recognized that the FDA favored politics over science, ideology over women's health, and violated the law in the process."