MedWatch to Manufacturer Program
The MedWatch to Manufacturer Program (MMP) allows drug and biologic manufacturers participating in the program to receive certain serious adverse events reports that are submitted directly to FDA by voluntary reporters.
The sponsor will be notified in the approval letter or by mail of eligibility of the product for inclusion. Manufacturers must send in an enrollment request letter for each eligible product.
Manufacturers may enroll any time after product approval and reports will be sent on enrollment. Reports received by FDA prior to the enrollment date will not be sent.
Products are eligible for inclusion for a period that will range from 3 to 4 years, the balance of the year approved plus the next three full calendar years. Products are deleted once a year, at the end of December. For example, a product with an approval date of March 23, 2004, will remain in the program until December 31, 2007. A product with an approval date of November 16, 2005, will remain in the program until December 31, 2008.
A copy of a report will be mailed to a manufacturer if all of the following conditions apply:
- The report must be on a New Molecular Entity (NME). An NME is a product that contains an active ingredient that has never been marketed in the United States. NMEs are classified as 1S or 1P or as an "important new biologic" when approved by the FDA. New dosage forms/formulations/combinations and new indications for older active ingredients are not considered NMEs. Requests for exceptions to the NME limitation are considered on a case-by-case basis.
- The report must be serious. The determination of seriousness is based solely on the outcome box(es) checked by the reporter in block B2 on the MedWatch form. The report will not have been evaluated by the FDA prior to transmission to the manufacturer.
- The report must include permission to disclose the reporter's identity to the manufacturer. Only reports where the reporter's name can be released to the manufacturer will be sent out. If the report is not on FDA Form 3500 or if the reporter checks box G5 on the form, the report will not be sent to the manufacturer.
- The manufacturer of the NME must be a participant in the program.
The enrollment request letter must contain:
- The name(s) of the NME(s), including the approval date(s). If requesting an exception, provide justification.
- A statement certifying that the company has the regulatory responsibility for post-marketing reporting of adverse experiences for the product(s).
- A statement that the company will conduct its normal follow-up of these reports in compliance with the applicable regulations.
- A statement that the company will maintain the confidentiality of the names of the reporters and the persons who are the subjects of the reports.
- A single contact person should be identified per manufacturer. This contact person is the individual who will receive the adverse event reports for all of the manufacturer’s participating products and correspondence relating to the Program. The letter should include the mailing address, telephone number, fax number, and e-mail address of the contact person. Manufacturers should promptly send notification to FDA of any changes in contact person information.
- The letter must be signed by the appropriate person responsible for safety surveillance by the firm.
Letters requesting participation in the MMP may be mailed to:
BA-ZAI companYAttn. MedWatch to Manufacturer Program
8201 Corporate Drive Suite 20
Landover MD 20785