FDA Chokes on Morning-After Pill

Excerpts from the GAO's 62-page report

[. . .]

"FDA officials gave conflicting accounts of when the not-approvable decision for the Plan B OTC switch application was made. FDA officials . . . told us that they were told by high-level management that the Plan B OTC switch application would be denied months before staff had completed their reviews of the application. The Director and Deputy Director of the Office of New Drugs told us that they were told by the Acting Deputy Commissioner for Operations 43 and the Acting Director of CDER, after the Plan B public meeting in December 2003, that the decision on the Plan B application would be not-approvable. They informed us that they were also told that the direction for this decision came from the Office of the Commissioner.”

[. . .]

"However, the Acting Director of CDER told us that he made the decision to not approve the Plan B OTC switch application shortly before signing the action letter. He also informed us that his decision was made in consultation with other high-level management officials, including the Commissioner and the Acting Deputy Commissioner for Operations, but that he was not directed to reach a particular decision.”

[. . .]

"The Acting Director of CDER told 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. For example, he noted increased access to Plan B could potentially result in an increase in unsafe sexual activity, particularly among younger adolescents-an age group, he noted, that has a tendency to engage in risky behaviors because of their level of cognitive development.”

[. . .]

"Although review staff . . . presented him with additional data on sexual behaviors of younger adolescents in association with increased access to ECPs [emergency contraceptive pills], the Acting Director of CDER determined that these data were not adequate to support the approval of Plan B for OTC use.”

[. . .]

"FDA review staff, the Directors of the Offices of Drug Evaluation III and V, and the Director of the Office of New Drugs disagreed with the Acting Director of CDER's rationale for not approving the Plan B OTC switch application. FDA review officials . . . noted that traditionally FDA has not considered whether younger adolescents would use an OTC product differently than older adolescents, and the Director of the Office of New Drugs told us that it was 'atypical' to raise the question of maturity during a drug review.. . .
"Review staff told us they examined benefit-risk issues for Plan B, and they concluded that concerns regarding the potential for unsafe sexual behaviors among adolescents could not be supported.”

[. . .]

"From 1994 through 2004, Plan B was the only prescription-to-OTC switch decision that was not approved after the joint advisory committee voted to recommend approval of the application. FDA advisory committees considered 23 OTC switch applications during this period; the Plan B OTC switch application was the only 1 of those 23 that was not approved after the joint advisory committee voted to recommend approval of the application. In addition, there has been only 1 other decision for an OTC switch application that did not follow the recommendations of the joint advisory committee.”

[. . .]

"According to the Deputy Director of the Office of New Drugs, there are no age-related marketing restrictions for any FDA-approved contraceptives, and FDA has not required any pediatric studies. Condoms and spermicides are available to anyone OTC, while intrauterine devices; diaphragms; cervical caps; and hormonal methods of contraception, including ECPs, are available to anyone with a prescription. For hormonal contraceptives, FDA has assumed that suppression of ovulation is the same in all postmenarcheal females, regardless of age.”

[. . .]

"While we agree with FDA that the Director of CDER and other high-level officials generally are more likely to become directly involved in high-profile regulatory decisions and noted that in the draft of the report, we found that this level of involvement is unusual for OTC switch applications.”

[. . .]

"FDA commented . . . that it is inaccurate to conclude that a decision to deny the application was made several months before the not-approvable letter was issued. However . . . the Director and Deputy Director of the Office of New Drugs and other officials told us that they were informed during December 2003 and January 2004 that the application would not be approved.”

[. . .]

"FDA disagreed with our finding that the Acting Director's rationale for denying the application was novel and did not follow FDA's traditional practices. FDA commented that the Acting Director's focus on the potential implications to the sexual behavior of adolescent women of approving the Plan B OTC switch application was appropriate and consistent with FDA's treatment of other OTC switch applications.”

[. . .]

"We found that the Acting Director's rationale was novel because it explicitly considered the differing levels of cognitive maturity of adolescents of different ages, and that because of the Acting Director's views about these cognitive maturity differences, he concluded that it was inappropriate to extrapolate data related to risky sexual behavior from older to younger adolescents.”
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