Accutane Questions and Answers...

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Accutane 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.

If you or anyone you know that have taken or been prescribed Accutane and has experienced harmful side-effects, please contact our accutane attorneys promptly and receive a free case review. .