Delay in Proposed Labeling Rule – Is FDA Listening to the Industry?


You all know my position on this issue based on multiple posts (here,  here, here, here, here, here, here, here, here, and here) (wow-you get the idea – there is a lot to be said and a lot riding on this Proposed Rule).  The news is that the FDA is postponing its decision on its Proposed Labeling Rule until July 2016.  Mark that month on your calendar because it will mark the time where either FDA adopts a modified position or the legal process will likely be initiated by many in the generic industry.

So what is it that FDA really wants to do by this Proposed Labeling Rule?  There are two major issues. One is rather direct and reasonable; that is, to make generic companies more proactive in changing their label to add new safety information.  The second, as I see it, is to undo the Mensing decision and give plaintiffs the leverage they need to sue for injury from generic products for not changing their labeling.   The first reason is certainly in the interest of public health and directly under the purview of the Agency responsibilities.  The second, however, is really not a change of the FDA and, in my opinion, has no place in an FDA Rule whether providing a direct or indirect benefit.  It is important to remember that the FDA can’t make law, nor can they change law through its regulatory authority.

The Proposed Rule would allow generic drug makers to unilaterally change their labels to add whatever new safety information they deem necessary.  Fear is that there can be multiple different versions of warnings on the same generic product, depending on what firm sells the drug.  This can cause confusion in the marketplace and undermine the Hatch-Waxman goal of assuring that generic drugs are the same as the innovator product they copy.  The sameness provisions of the Hatch-Waxman Act and the regulations as currently written requires the generic label to be the same as the brand name product.  Generic companies feed into the safety database of the Agency by their postmarking surveillance and reporting of adverse events.  The Agency receives all of the information from the brand name NDA holder and all of the generic equivalent products, so they are the only entity that has all of the information necessary to make any final label change decisions.

The Agency argues that, because over 80% of all prescriptions filled are for generic versions of the medication, generic sponsors should take a more active role by changing their label when they learn of a new safety issue.  However, seeing a single unusual adverse event here and there does not always mean that the drug actually caused the event or that the label should be changed.  There is a process in place now for such changes to be evaluated by the Agency.  In addition, it is clear that FDA thinks that some generic companies may not be living up to their responsibilities in adverse event reporting; however, FDA has a compliance program that reviews firms performance towards fulfilling that requirement and we don’t see many Warning Letters or FDA Form 483 citing egregious nonconformance being issued by the FDA.

In the Proposed Rule, the Agency also explained that, when the NDA product is no longer being marketed, a gap arises in the reporting, as well as the proactive ability for a sponsor to make a label change.  However, we must remember the current regulations provide that, in the case where an NDA is discontinued from marketing, the FDA has the responsibility and is required to initiate label changes for generic products.  In addition, the current legislation gives the FDA authority to require even brand name manufacturers to revise labeling if the FDA has a safety concern, even if the sponsor disagrees.

I am worried that the Rule as currently proposed may force sponsors to take an action to revise their label, even if there is no solid evidence that the event is drug-related in an effort to practice defensive labeling to avoid liability.  There have been alternate approaches put forward that have the endorsement of both PhRMA and GPhA that are more workable and will provide a systematic approach to maintain label sameness while assuring appropriate safety review by the Agency.  Let’s hope the 8-month time delay for finalization of the publication of the Rule, whether repurposed or final, signals a willingness of the FDA to adopt an alternate approach from its original Proposed Rule and takes into account the numerous comments and suggestions the FDA has received.