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FDA's Decision Regarding Plan
B: Questions and Answers
Please see
Questions and Answers, August 24, 2006
1. What is emergency contraception?
Emergency contraception is a method of preventing
pregnancy to be used after a contraceptive fails or after
unprotected sex. It is not for routine use. Drugs used for this
purpose are called emergency contraceptive pills, post-coital pills,
or morning after pills. Emergency contraceptives contain the
hormones estrogen and progestin (levonorgestrel), either separately
or in combination. FDA has approved two products for prescription
use for emergency contraception – Preven (approved in 1998) and Plan
B (approved in 1999).
2. What is Plan B?
Plan B is emergency contraception, a backup method to birth control.
It is in the form of two levonorgestrel pills (0.75 mg in each pill)
that are taken by mouth after unprotected sex. Levonorgestrel is a
synthetic hormone used in birth control pills for over 35 years.
Plan B can reduce a woman’s risk of pregnancy when taken as directed
if she has had unprotected sex. Plan B contains only progestin,
levonorgestrel, a synthetic hormone used in birth control pills for
over 35 years. It is currently available only by prescription
3. How does Plan B work?
Plan B works like other birth control pills to prevent pregnancy.
Plan B acts primarily by stopping the release of an egg from the
ovary (ovulation). It may prevent the union of sperm and egg
(fertilization). If fertilization does occur, Plan B may prevent a
fertilized egg from attaching to the womb (implantation). If a
fertilized egg is implanted prior to taking Plan B, Plan B will not
work.
4. What steps did FDA take in considering switching Plan B from
prescription to nonprescription (over-the-counter (OTC)) status?
FDA received an application to switch Plan B from prescription to
nonprescription status. FDA staff reviewed the scientific data
contained in the application which included among other data, an
actual use study and a label comprehension study.
On December 16, 2003, we held a public advisory committee meeting
with a panel of medical and scientific experts from outside the
federal government. The members of the Nonprescription Drugs
Advisory Committee and the Advisory Committee for Reproductive
Health, met jointly to consider the safety and effectiveness data of
nonprescription use of Plan B. Although the joint committee
recommended to FDA that this product be sold without a prescription,
some members of the committee, including the Chair, raised questions
concerning whether the actual use data were generalizable to the
overall population of nonprescription users, chiefly because of
inadequate sampling of younger age groups.
Following the advisory committee meeting, FDA requested additional
information from the sponsor pertaining to adolescent use. The
sponsor submitted this additional information to FDA in support of
their pending application to change Plan B from a prescription to an
over-the-counter product. This additional information was extensive
enough to qualify as a major amendment to the NDA. Under the terms
of the Prescription Drug User Fee Act (PDUFA) performance goals,
major amendments such as this may trigger a 90-day extension of the
original PDUFA deadline.
Now FDA has completed its review of the supplemental application and
concluded that the application could not be approved at this time
because 1) adequate data were not provided to support a conclusion
that young adolescent women can safely use Plan B for emergency
contraception without the professional supervision of a licensed
practitioner and 2) a proposal from the sponsor to change the
requested indication to allow for marketing of Plan B as a
prescription-only product for women under 16 years of age and a
nonprescription product for women 16 years and older was incomplete
and inadequate for a full review. Therefore, FDA concluded that the
application was not approvable.
5. Why didn’t FDA follow the recommendation of the Advisory
Committees?
The recommendations of FDA advisory committees are advisory in
nature and the Agency is not bound to follow their recommendations.
FDA makes a decision on whether a product should be approved after
evaluating all data and considering the recommendations of the
advisory committee.
6. Why did FDA issue a Not Approvable letter?
The agency issued a Not Approvable letter because the supplemental
application did not meet the criteria for approval in that it did
not demonstrate that Plan B could be used safely by young adolescent
women for emergency contraception without the professional
supervision of a licensed practitioner. The issuance of a Not
Approvable letter does not mean that a supplemental application
cannot be approved. The Not Approvable letter describes what the
applicant would need to do to obtain approval for the supplemental
application. In this case, the applicant would have to either
provide additional data demonstrating that Plan B can be used safely
by women under 16 years of age without the professional supervision
of a practitioner licensed by law to administer the drug or provide
additional support for the revised indication to allow for marketing
Plan B as prescription-only for women under the age of 16 and as
nonprescription for women 16 years of age and older.
Not Approvable Letter.
7. Was there a difference of opinion within the Center for Drug
Evaluation (CDER) and Research regarding the final decision?
Yes, there was a difference of opinion within CDER. The scientific
interchange of ideas is widely encouraged during the review process
to ensure a thorough vetting of the issues. However, ultimately, a
final decision must be made based on the evaluation of the data,
taking into account all of the views expressed.
8. Is this FDA’s final decision regarding the availability of
Plan B for OTC use?
No. The Not Approvable letter to the sponsor outlines what the
sponsor must do to obtain approval of the supplemental application.
Wide availability of safe and effective contraceptives is important
to public health. We look forward to working with the sponsor if
they decide to pursue making this product available without a
prescription.
9. Oral contraceptives have been used for four decades, and this
product has been approved and used safely since 1999. How could FDA
turn it down?
Oral contraceptives as a class of drugs are only available by
prescription. This product has been used safely by prescription only
and for the reasons already stated, it is not being made available
for OTC use at this time.
10. The sponsor has talked about making the product
over-the-counter for young women over a certain age and
behind-the-counter for younger girls. Is there evidence to support
such a scheme? Does FDA have the authority to carry it out?
The sponsor has submitted a plan and the FDA is examining its
regulatory authority to approve a product marketed in this manner.
11. Did the FDA bow to political pressure in making this
decision?
No. This decision was made within the Center for Drug Evaluation and
Research.
12. Dr. Steven Galson signed the letter FDA sent to the sponsor.
Does Dr. Galson usually sign such letters? Why did Dr. Galson sign
the letter?
No, Dr. Galson does not usually sign regulatory action letters.
However, his opinion of the adequacy of the data in young
adolescents differed from that of the review staff. He believes that
additional data are needed and for that reason he made the decision
to take final action within the Office of the Center Director.
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Date created: May 7, 2004, updated August 24, 2006 |
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