This is a the second part of the blog on the Generic Pharmaceutical Association (“GPhA”) / FDA / United States Pharmacopeia (“USP”) ANDA Labeling Workshop/USP User Forum held in Bethesda, Maryland on September 11-12, 2013. Following Rudy Wu, Pham. D., M.P.H., Team, Leader, Labeling Branch, OGD, Scott Dallas, R.Ph., Labeling Reviewer, OGD, provided an overview of OGD’s view of medication errors, which has built upon several reports by the Institute of Medicine in 1999 and 2006. FDA has been working with a Merck labeling initiative to see how products can be modified to be more easily distinguished in particular on the pharmacist’s shelf. Generic drugs, just like their innovator counterparts, may be confused by similar trade dress or packaging, which should be a consideration when filing an application, Dallas noted. In addition, specialty packaging, such as blister packs or clear parenteral doses have been an issue, Dallas explained, where space for labeling is tight and often difficult to read for practitioners.
Carrie Lemley, OGD’s only current Labeling Project Manager, described OGD’s labeling review as a multidisciplinary process. Regarding products with mandated risk evaluation and mitigation strategies (“REMS”), Lemley said OGD is tracking FDA’s process to standardize REMS (see related blogs here and here). In particular, if generic applicants are supposed to use a single, shared system for the elements to assure safe use (“ETASU”), FDA expects the RLD sponsor and generic drug applicants to work together to develop the single, shared program.
To date, FDA has only granted one waiver (buprenorphine) to permit both an RLD and shared generic REMS, but FDA contemplates that waivers will only be granted with well-rationalized reasons, i.e., more than an inability to get along. ANDA applicants, however, are not responsible for developing a communication plan or assessments for REMS but is expected to update its REMS in line with the RLD, e.g., if FDA with draws the REMS requirement, a generic applicant should also request to withdraw its REMS (The process is not automatic.) In response to questions about the waiver process, Lemley stated that there is no formal process but the elements to include in a waiver request are:
- Description of efforts to negotiate and decision makers,
- Justification for waiver including inability to work out issues regarding control or finances,
- Explanation how a waiver would affect everybody in that system and how two systems could co-exist instead of one,
- Accounting of cost issues for implementation, and
- Anticipation of the burden on the healthcare system and consumers for the separate systems.