By Steve Weinstein
By Devon Maloney
By Tessa Stuart
By Alison Flowers
By Albert Samaha
By Jesse Jarnow
By Eric Tsetsi
By Raillan Brooks
A decision about whether to put the emergency contraceptive marketed as Plan B on drug store shelves has been stalled inside the Food and Drug Administration for nearly two years. Plan B, in essence, is a booster dose of the ordinary birth-control pill.
Scientific review panels for the FDA and FDA staff studied the morning-after pill and said it was safe enough to sell over the counter. But in May 2004, the upper management of the FDA, perhaps with an ear toward the religious right's objections, said no. At issue, said FDA management, is that teenagers could buy the drug.
Monday's GAO report on the morning-after pill came at the request of a group of several dozen lawmakers, including senators Ted Kennedy and Hillary Clinton. Barr Pharmaceuticals, which makes Plan B, has had a revised application pending for more than yearthis one to allow over the counter sale to women older than 16. Clinton in particular has continued to press for a decision.
In its report, the GAO describes a paternalistic government agency that made its mind with little regard for science. The GAO notes: The Acting Director of CDERthe Center for Drug Evaluation and Researchtold us he signed the not-approvable letter because of his concerns about the lack of cognitive development and the potential for risky behaviors among younger adolescents resulting from increased access to Plan B.
What follow are more excerpts from the report, titled Food and Drug Administration: Decision Process to Deny Initial Application for Over-the-Counter Marketing of the Emergency Contraceptive Drug Plan B Was Unusual.
Though filled with government-speak, the report is a must-read for anyone who cares about women's access to contraception.
"Four aspects of FDA's review process were unusual: officials who would normally have been responsible for signing an action letter disagreed with the decision and did not sign the not-approvable letter for Plan B; high-level management was more involved than for other OTC switch applications; conflicting accounts exist of whether the decision to not approve the application was made before the reviews were completed; and the rationale for the not-approvable decision was novel and did not follow FDA's traditional practices.
[. . .]
(Editor's note: The FDA's director of the Center for Drug Evaluation and Research met with review staff on January 15, 2004, about the position of the FDA commissioner on the morning-after pill.)
"FDA's minutes from this meeting stated that the Acting Director of CDER informed review staff that a not-approvable letter was recommended based on the need for more data to clearly establish appropriate use in younger adolescents.
[. . .]
"According to review staff . . . at this January 2004 meeting the Acting Director of CDER also told them that the decision on the Plan B OTC switch application would be made at a 'level higher than them. . . .'
[. . .]
"On February 18, 2004, review staff . . . presented their findings to high-level management, including the Commissioner and the Acting Director of CDER. According to interviews with officials from the Office of New Drugs and review staff . . . they said these data provided sufficient evidence that there was neither an increase in risky behaviors nor any difference in appropriate use between younger adolescents and older populations. According to FDA's minutes of this meeting, the Commissioner expressed multiple points, including the potential for changes in future contraceptive behaviors after adolescents took Plan B and that counseling by a learned intermediary might be beneficial, particularly for adolescents.
[. . .]
"By early April 2004, the reviews from the Offices of Drug Evaluation III and V were completed. The directors of these offices agreed with the recommendations of the joint advisory committee and review staff that Plan B should be made available without a prescription. Nonetheless, the office directors told us that they were asked by high-level management to draft a not-approvable letter. Both office directors also told us they did not agree with a not-approvable action and did not sign the not-approvable letter.
"The issue was then raised to the Office of New Drugs. The Director of the Office of New Drugs reviewed the staff's analysis of the application and concurred with the recommendations of both office directors. He also did not sign the not-approvable letter. The Director of the Office of New Drugs told us that it was 'very, very rare' that his office would become involved in the signing of an action letter.
[. . .]
"According to review staff . . . at a meeting held on January 15, 2004, the Acting Director of CDER informed them that the decision for the Plan B OTC switch application would be made by high-level management. This action removed decision-making authority from the directors of the reviewing offices who would normally make the decision. According to minutes from a subsequent meeting between review officials and the sponsor on January 23, 2004, the Director of the Office of New Drugs informed the sponsor that such a high-level decision was not typical of CDER's procedures for drug approvals.
"The Acting Director of CDER told us that management needed to be comfortable with review staff's final decision because of the high visibility and sensitivity of the Plan B OTC switch application. He and other senior FDA officials told us that involvement by high-level management stemmed from the agency's practice of delegated authority. In addition to highly visible and sensitive cases, they said that the Commissioner and the Director of CDER would also generally become involved in cases that would potentially have a far-reaching impact or in cases in which management had a different view or disagreed with review staff.