We heard it was coming ever since the Department of Justice hinted the FDA was contemplating a change to permit generic application holders to revise their labeling to make safety changes.  Something the Supreme Court actually said generic companies could not do in the Mensing and Bartlett decisions.  The Office of Information and Regulatory Affairs of the Office of Management and Budget made the post below that described the intention of the publication of a proposed rule on Reginfo.gov.

HHS/FDA RIN: 0910-AG94 Publication ID: Spring 2013


Title: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
Abstract: This proposed rule would amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA’s review of such change. The proposed rule would describe the process by which information regarding a “changes being effected” (CBE) labeling supplement submitted by an NDA or ANDA holder would be made publicly available during FDA’s review of the labeling change. The proposed rule also would clarify requirements for the NDA holder for the reference listed drug and all ANDA holders to submit conforming labeling revisions after FDA has taken an action on the NDA and/or ANDA holder’s CBE labeling supplement. These proposed revisions to FDA’s regulations would create parity between NDA holders and ANDA holders with respect to submission of CBE labeling supplements.
Agency: Department of Health and Human Services(HHS) Priority: Other Significant
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage
Major: Undetermined Unfunded Mandates: No
CFR Citation: 21 CFR 314.70; 21 CFR 314.97; 21 CFR 314.150; 21 CFR 601.12
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 352; 21 USC 353; 21 USC 355; 21 USC 371; 42 USC 262; …



The projected time for publication of the Notice of Proposed Rule Making (NPRM) was cited as September 2013. 

We have discussed potential problems with permitting generic companies to change their labeling without following the brand name changes or FDA mandated changes in other posts.  Such problems include, but are not limited to, inconsistencies in labeling, confusion of the physicians and patients due to differing information in labeling, procedures for label changes after a single generic manufacturer changes its label.  There will be a potential for defensive over-warning, which may have the tendency of warnings to have less of an impact.  The proposed change also raises other important questions like: Would other generics be expected to revise their labeling to comply with the first generic’s changes?  What about NDA holders – should they be required to make those same changes?  There is also one other major obstacles, in that the law requires generic labeling to comply with the reference listed drug (RLD) labeling.  Can a rule change trump the statute?

While the current system has been working well for over 30 years, some claim that the Mensing and Bartlett cases decided by the Supreme Court take away the ability of injured patients to gain relief through the courts.  As mentioned in my post of June 26, 2013 (here), the Supreme Court’s decisions let the safety and efficacy determinations stay in the hands of the FDA where it belongs and not in the hand of a jury or the Court.  Perhaps the real solution is not to change the regulations, but to revise the tort system.  Maybe now is the time to consider a program like the National Vaccine program that permits compensation for patients injured by a vaccine.

We know that every drug has side effects and some are devastating.  But it is the physician and the patient that must decide if the risk of taking the drug outweighs the benefits for the specific individual.  Once the decision to take a drug is made, then there must also be acceptance of the risk associated with the treatment. Hatch-Waxman did create a difference between innovators and generic applicants and assigned them different responsibilities.  The legislation struck a balance that permitted certain benefits to accrue to the innovator in terms of patent and exclusivity protection in turn for permitting generics applicants to rely on the safety and efficacy findings of the FDA and that of the innovator product.

Allowing every generic applicant to changes its label on its own will not change a thing.  Physicians typically do not read the generic label and rely on the labeling of the brand name product and/or their knowledge of the drug.  This idea of a proposed rule that would allow a generic labeling change could also shift the burden of warnings relative to the myriad of generic products more from the physician to the pharmacist.  In a defensive maneuver to limit liability, pharmacists may seek to stock a generic product that has the most warnings, even if the labeling is eventually not approved by the FDA and some of the warnings are found to be inappropriate.  In my opinion (and for a number of reasons), this potential rule change could cause real chaos in the marketplace.  Keep your eyes open in September for the NPRM, we will report more on it when it is published.