February 26, 2004
The Honorable Mark B. McClellan, M.D., Ph.D.
Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
Dear Dr. McClellan:
Recently, the Food and Drug Administration announced a delay in
its consideration of Barr Laboratories’ application for over-the-counter
(OTC) status for the emergency contraception drug Plan B.1 Since
the joint advisory committee that considered this application voted
overwhelmingly to approve it, the delay does not appear to have
a scientific basis. We understand that you will soon be leaving
FDA and we hope that you act on this application before you leave.
The scientific standards for approval of an OTC application are
straightforward. When a firm submits a supplemental New Drug Application
for a previously-approved prescription drug to be switched to OTC
status, it must demonstrate that consumers can use the drug safely
and effectively without professional supervision.2 Advisory Review
Panels composed of experts on the relevant category of drug must
consider evidence on safety, effectiveness, and labeling and make
a recommendation to the Commissioner regarding the switch.3
In the case of Plan B, an overwhelming majority of the experts
found that the standards for approval of OTC status had been met.
The Nonprescription Drugs and Reproductive Health Drugs Advisory
Committees met jointly on December 16, 2003, to discuss evidence
on Plan B.4 FDA instructed the panel to answer a set of questions
relating to the safety and effectiveness of the drug; the questions
and voting tallies were as follows:
1. Does the actual use study demonstrate that consumers used the
product as recommended in the proposed labeling? 27 Yes; 1 No
2. Is the actual use study data generalizable to the overall population
of potential non-Rx users of Plan B? 27 Yes; 1 No
3. Based on the actual use study and literature review, is there
evidence that non-Rx availability of Plan B leads to substitution
of emergency contraceptive for the regular use of other methods
of contraception? 0 Yes; 28 No
4. Does the data demonstrate that Plan B is safe for use in the
nonprescription setting? 28 Yes; 0 No
5. Are the plans for introduction of Plan B into the non-Rx setting
adequate with respect to consumer access and safe use? 22 Yes;
5 No; 1 Abstain
6. Do you recommend Plan B be switched from Rx to non-Rx status?
23 Yes; 4 No
Despite the strong vote in support of making the drug available
without a prescription, FDA has delayed this decision. While FDA
is certainly not bound by the decisions of its advisory committees,
it is unusual for an advisory committee recommendation not to be
adopted, especially in a case such as this where the vote was so
strong and where there is so little evidence to support a decision
not to adopt the panel’s recommendation.
According to press accounts, this delay follows pressure from
conservative Members of Congress who speculate that improved access
to Plan B would increase “promiscuity” and sexually
transmitted diseases among teenagers.5 The press is also reporting
that you have asked Barr Laboratories to provide you with data on
this question.6 During its deliberations, the advisory committee
considered whether there was any evidence that the availability
of Plan B would result in the substitution of Plan B for other means
of contraception. The panel voted unanimously that there is no evidence
that a substitution would occur. Furthermore, over-the-counter availability
of Plan B has been endorsed by both the American Academy of Pediatrics
and the Society for Adolescent Medicine. They assert in a joint
letter that “[i]t is important to provide easily accessible
and affordable emergency contraception for adolescents whose contraception
fails or is not used during the most recent sexual encounter.”7
There is increasing concern among the scientific community that
the Bush Administration is letting politics and ideology interfere
with scientific decision-making. In cases like this one, such interference
could have a direct and irreversible effect on the health and well-being
of thousands of women.
As you review the data on Plan B and decide whether to make this
crucial drug available to more women, we urge you to ensure that
FDA carries on its mission as a science-based agency even in the
face of political pressure.
Sincerely,
(Signed by forty eight members of Congress. See pdf letter below
for full list of signatories) |