On March 27, 2015, FDA plans to hold a public meeting entitled, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products”. The meeting was announced in a Federal Register Notice posted on February 18, 2015. As noted later, there are some critical registration or comment dates coming up to consider for this important topic.
FDA proposed regulations on November 13, 2013 that would have permitted newly-acquired safety-related information to be submitted in a changes being effected (CBE-0) supplement to FDA for either approved new drug applications (NDAs), biologics license applications (BLAs), or abbreviated new drug applications (ANDAs). Currently, ANDA holders are required to have the same labeling as their referenced listed drug (RLD). The proposed rule was intended, FDA explained, to allow generic drug manufacturers to update product labeling through CBE-0 supplements to improve communication of important, newly-acquired drug safety information to health care professionals and the public. In addition the proposed rule stated in its preamble:
As a result of the decisions in Wyeth v. Levineand Pliva v. Mensing, an individual can bring a product liability action for failure to warn against an NDA holder, but generally not an ANDA holder, and thus access to the courts is dependent on whether an individual is dispensed a brand name or generic drug. The Mensingdecision alters the incentives for generic drug manufacturers to comply with current requirements to conduct robust postmarketing surveillance, evaluation, and reporting, and to ensure that the labeling for their drugs is accurate and up-to-date.
FDA’s proposed process would have enabled either the NDA or ANDA holder to be first with the new safety information and CBE-0 but would have provided notice to all other related NDA or ANDA holders with the proposed labeling change and support for it, including a public webpage with the pending safety labeling change. Once FDA confirmed the appropriate language for the labeling change, it would be communicated to the NDA holder, and ANDA holders would have 30 days to institute conforming labeling changes.
FDA received numerous comments on the proposal. One comments that FDA singled out was filed by the Generic Pharmaceutical Association (GPhA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) dated November 14, 2014. This comment proposed an alternative solution, called the “Expedited Agency Review” (EAR) that would provide time parameters for FDA to take action on “new safety information” provided by NDA or ANDA holders, based on FDA’s own monitoring of safety signals through its Sentinel System or other measures. The plan was summarized in the proposal as follows:
Step 1. NDA or ANDA holder requests EAR or FDA initiates EAR on its own.
Step 2. FDA begins review of all available safety data and engages NDA and ANDA holders in discussion of potential label change.
Step 3. If FDA determines through a review of all available safety data that a labeling change is required, FDA informs the NDA and ANDA holders of the content of the final labeling language immediately (within 15 days) and instructs the NDA and ANDA holders to update their labeling within 30 days via e‐labeling.
Step 4. All application holders update labeling via e‐labeling within 30 days.
In response to the comments thus received, FDA decided to hold off on its proposed rulemaking until it had a chance for a public meeting to discuss the topic further and provide time for additional public written comments.
Registration to attend the public meeting must be received by March 20, 2015, and individuals who wish to present must register on or before March 16, 2015. FDA also plans to stream a Webcast of the meeting during the meeting. Comments will be accepted after the public meeting up through April 27, 2015.