FDA's Decision Regarding
Plan B: Questions and Answers
1. What is
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 Ė
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 womanís 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))
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
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
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
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 didnít 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 FDAís 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
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