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Accutane (isotretinoin) Questions and Answers
- Why is FDA
taking this action?
In February 2004, FDA convened the
Drug Safety and Risk Management and the Dermatologic and Ophthalmic
Drug Advisory Committees to discuss the effectiveness of the System
to Manage Accutane Related Teratogenicity (S.M.A.R.T.) program for
the prevention of fetal exposure to Accutane and its generic
equivalents and to consider whether changes to this risk management
plan (riskMAP) would be appropriate. Today’s changes reflect the
Agency’s response to the joint committees recommended strengthening
of the isotretinoin riskMAP to include mandatory registration of all
prescribers, pharmacies and patients, and mandatory linkage of
negative pregnancy testing to prescription dispensing for female
patients of childbearing potential.
- What do
the patents cover?
These business process patents are
registered by Celgene and refer to its risk management program,
STEPS, for thalidomide.
- Why is
Celgene involved in the isotretinoin program improvement?
Celgene is the owner of the business
process patents on components which will be essential elements of
the new isotretinoin RiskMAP. Celgene is not involved in the
strengthened isotretinoin RiskMAP aside from the patent
negotiations.
- What is
different about the new program?
The new program will link prescribers,
patients and pharmacies through a single centralized registry. The
registry, or clearinghouse, will confirm that an appropriately timed
pregnancy test is negative prior to authorizing the dispensing of an isotretinoin prescription for a female patient who is capable of
becoming pregnant, and that informed consent, counseling, and
patient education have occurred.
- How soon
will the program be implemented?
The tentative date for implementation
is July 2005. Once all the program details have been agreed upon,
the changes will need to be incorporated into labeling.
- Will this
make it harder for patients to get isotretinoin?
The Agency understands the importance
of minimizing any burden imposed upon patients and health care
providers by the strengthened RiskMAP. It is not expected that it
will be substantially more difficult for female patients capable of
becoming pregnant to obtain isotretinoin under the strengthened
RiskMAP than it would have been for such patients who, along with
their prescribers, were fully compliant with the S.M.A.R.T. program.
It is possible that some healthcare providers will choose not to
participate in the strengthened RiskMAP.
- Why did it
take FDA so long to make the changes to the RMP considering the
advisory committee meeting was in Feb 2004?
The Agency understood the public
health urgency of implementing the February 2004 recommendations of
the joint Advisory Committees to strengthen the isotretinoin RiskMAP. The innovator and generic sponsors of isotretinoin have worked
diligently to reach an agreement with Celgene Corporation, which
holds patents on business processes which will be essential elements
of the strengthened RiskMAP. Since an agreement has now been
achieved, the program can move forward in full compliance with
recommendations of the agency and members of the Drug Safety and
Risk Management and the Dermatologic and Ophthalmic Drug Advisory
Committees.
- Is this an
acknowledgement that the past system, SMART, did not work?
The SMART program strengthened the
prior RiskMAP, entitled the Pregnancy Prevention Program, which had
been innovative at the time of its implementation. However, the
SMART program was not as effective as had been hoped for in reducing
the number of pregnancies exposed to isotretinoin. The Agency is
committed to safeguarding the public health by ensuring that
effective tools are in place to minimize the risks associated with isotretinoin use for those patients who need treatment with this
drug. Such a commitment will likely involve ongoing evaluation of
the isotretinoin RiskMAP, with additional efforts to strengthen the
program further if protection of the public health so warrants.
- Was there
political pressure from Congress?
The Agency and Congress have a shared
commitment to optimizing patient safety and effective use for
marketed drug products. Other responsible stakeholders include
members of the maternal-fetal health, pediatric, dermatologic, and
pharmacy communities within the healthcare environment.
-
Who and
what information will be in the registry?
Patients and prescribers will each be
assigned a unique identifying number, which will not be used outside
of the registry/clearinghouse. For female patients capable of
becoming pregnant, the registry/clearinghouse will authorize
dispensing of isotretinoin based, among other things, on the
presence of an appropriately-timed, negative pregnancy test. However, in instances in which dispensing is not authorized, the
reason for denial of authorization (pregnancy test not performed, prescriber not registered, pregnancy test not appropriately timed,
dispensing window expired, or positive pregnancy test), will not be
communicated directly to the patient. Positive pregnancy test
results will not be communicated to the patient via the registry;
the patient will obtain this information from her healthcare
provider.
-
Were privacy
concerns taken into consideration?
Privacy concerns are of critical
importance. They have been carefully considered from the beginning
and will continue to be taken into account as the details of the
program are finalized.
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Date created: November 23, 2004, updated August, 2005 |
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