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July 31, 2006

NDA 21-045/S-001

Duramed Research, Inc.
Attention: Joseph A. Carrado, M.Sc., R.Ph.
Senior Director, Regulatory Affairs
One Belmont Ave, 11th floor
Bala Cynwyd, PA  19004

Dear Mr. Carrado:

Please refer to your supplemental new drug application (sNDA) dated April 16, 2003, received April 22, 2003, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Plan B® (levonorgestrel) Tablets, 0.75 mg.

In our August 26, 2005, letter to you we stated that the Agency was unable to reach a decision on the approvability of your application at that time because of unresolved difficult and novel issues raised by your sNDA.  On the same day, the Agency issued an Advanced Notice of Proposed Rulemaking (ANPRM) seeking input from the public on certain issues regarding Rx to OTC switches, which related to the regulatory issues raised by your application.  The comment period on the ANPRM closed on November 1, 2005, and the Agency received approximately 47,000 comments.  FDA then hired a contractor to summarize and categorize the comments, and we received the contractor’s final reports on May 19, 2006.  FDA has reviewed the comments and, while they have provided the agency with valuable insights regarding how the Agency might enforce an age-based restriction like the one proposed by your amended sNDA, we concur with the overwhelming majority of the comments (from individuals both for and against the approval of your sNDA) that it is not necessary to engage in rulemaking to resolve the novel regulatory issues raised by your application.

We are now proceeding with further evaluation of your sNDA.  We would like to meet with you as soon as practicable, and preferably within seven days, to discuss the status of your sNDA, including any necessary amendments.  For example, your sNDA seeks approval for OTC use for women ages 16 and older.  As we informed you in our August  26, 2005 letter, the Center for Drug Evaluation and Research concluded the available scientific data are insufficient to support the safe use of Plan B® as an OTC product for everyone in that age group.  Moreover, because of enforcement considerations, we believe that the appropriate age for OTC access is 18.  Should you desire to proceed with your sNDA, you would need to amend it to seek approval for OTC status for women ages 18 and older.  In addition, you would need to amend your sNDA with respect to packaging.

We would also like to discuss the details of the CARESM Program that you submitted with your sNDA.  That program regards your proposed marketing, education, distribution, and monitoring for the OTC version of Plan B®.  Specifically, we would like to learn more about your proposal to restrict distribution of Plan B® to certain pharmacies, i.e., the OTC version of Plan B® would not be available at gas stations, convenience stores, etc., but only to those pharmacies agreeing to (1) keep the OTC version of the drug behind the pharmacy counter and (2) dispense the drug only upon the production of a valid photo identification card establishing the age of the consumer.  In particular, we would like to learn more about your plan to routinely monitor these pharmacies to make sure they comply with the restricted distribution plan.  In addition, we are very interested in learning how you plan on enforcing the restrictions if a pharmacy fails to comply with them, e.g., whether the restrictions will be incorporated into the terms of a formal contract and, if so, what the terms of that contract (particularly those terms related to a breach) look like.  If after our discussions we conclude that the CARESM Program isn’t sufficiently rigorous to prevent the OTC version of Plan B® from being used by young girls who can’t safely use the product without the supervision of a practitioner licensed by law to administer the drug, Plan B® will remain Rx-only for women of all ages.

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