FDA Rejection of Plan B ‘Unusual,’ GAO Report Says

FDA's 2004 rejection of Barr Pharmaceuticals' application to allow nonprescription sales for the emergency contraceptive Plan B was "unusual," and "not typical" of FDA's regular review process, according to a GAO report released on Monday, the Los Angeles Times reports (Alonso-Zaldivar, Los Angeles Times, 11/15). The 57-page report found many "unusual" aspects regarding the handling of Barr's application, including atypical involvement of senior staff and a "novel" rationale for rejection of the application (Rockoff, Baltimore Sun, 11/15).

FDA in May 2004 issued a "not approvable" letter in response to the application, citing inadequate data on Plan B use among girls under age 16. The decision contradicted the recommendations of two FDA advisory panels, which in December 2003 voted 23-4 to recommend that Plan B be sold without a prescription.

In addition, the letter was signed only by Steven Galson, then-acting director of FDA's Center for Drug Evaluation and Research, and not by members of the FDA review team, as is routine. Galson later acknowledged that he made the decision to reject the application on his own and did not follow the recommendations of his staff (California Healthline, 10/13).

Galson said he was worried about how sales of Plan B to younger adolescents might affect their behavior, reasoning that it was inappropriate to apply data about the behavior of older adolescents to younger ones (GAO report, 11/14).

However, the report says FDA in previous applications "routinely" accepted behavior data from older adolescents to predict patterns among younger adolescents. Therefore, Galson's rationale for rejection based on inadequate Plan B data for girls under age 16 was "novel," according to the report (Harris, New York Times, 11/15).

After FDA rejected Barr's first application in May 2004, the company submitted another application to make nonprescription Plan B available only to women ages 17 and older. Former FDA Commissioner Lester Crawford in August announced that the agency would indefinitely defer the application and opened a 60-day public comment period on it, which expired on Nov. 1 (California Healthline, 11/2).

According to the report, high-level officials at FDA told some staff members as early as January 2004 that the agency would reject Barr's application to allow nonprescription sales of Plan B even though the scientific review for the application was not completed until April 2004 (Baltimore Sun, 11/15). Some leaders of FDA science divisions and offices recalled that Galson and Deputy Commissioner for Operations Janet Woodcock told them the application would not be approved (Kaufman, Washington Post, 11/15).

"FDA review staff told us that they were told early in the review process that the decision would be made by high-level management," the report said (New York Times, 11/15).

However, Woodcock and Galson recalled only that they discussed a possible rejection and potential hurdles for approval (Washington Post, 11/15).

Galson told GAO investigators that "although he was '90% sure' as early as January 2004" that he would reject the application, he did not make the final decision until reviewing all the scientific evidence (New York Times, 11/15).

The report also found "conflicting reports" about whether the office of then-FDA Commissioner Mark McClellan gave "direction" to reject the application after a December 2003 meeting, the Wall Street Journal reports (Wilde Mathews, Wall Street Journal, 11/15).

McClellan in a written document to investigators said his involvement in Barr's application was typical, adding that the decision was made after he left FDA (Baltimore Sun, 11/15).

"We question the integrity of the investigative process that results in such partial conclusions by the GAO," an FDA spokesperson said on Monday, adding, "The report mischaracterizes facts and does not appear to take into consideration the input provided by the FDA" (Wetzstein, Washington Times, 11/15).

In a statement, FDA added that it "complied fully" with the GAO investigation and that it "stand[s] by the original decision" (Los Angeles Times, 11/15).

Susan Wood -- who resigned from her position as FDA assistant commissioner for women's health earlier this year because of the agency's handling of the issue -- said, "This report is a sad reminder of why I felt compelled to resign." She added, "Instead of improving and advancing women's health, the FDA leadership is ignoring its process and not relying on science and medical evidence" (Washington Post, 11/15).

Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.) in a statement said, "The GAO has confirmed what we have always suspected, that this was a politically motivated decision that came down from the highest levels at the FDA" (Richwine, Reuters, 11/14).

Rep. Henry Waxman (D-Calif.) and 17 other lawmakers sent a letter to HHS Secretary Mike Leavitt urging him to monitor FDA for any "manipulation of science" and to consider Barr's application "based on the best available science instead of ideology."

Wendy Wright, senior policy director for Concerned Women for America, said approval of nonprescription Plan B might increase the spread of sexually transmitted diseases, adding, "So, the fact that the GAO report is finding that Plan B was handled differently is good news for women's health."

Barr spokesperson Carol Cox in a statement said, "We continue to believe that our Plan B emergency contraceptive product is safe and effective and should be approved for [nonprescription] use" (Baltimore Sun, 11/15).

The report is available online. Note: You must have Adobe Acrobat Reader to view the report.

NPR's "Morning Edition" on Tuesday reported on Plan B. The segment includes comments from Murray and Rep. Carolyn Maloney (D-N.Y.). (Rovner, "Morning Edition," NPR, 11/15). The complete segment is available online in RealPlayer.