GPhA Submits Comments to FDA on Proposed Rule

Yesterday, the Generic Pharmaceutical Association (GPhA) provided 24 pages of comments in response to the FDA’s Proposed Rule to permit generic applicants to unilaterally add or modify warnings in its label prior to FDA approval and prior to the revision of the reference listed drug’s (RLD) labeling.

The entire set of comments can be found here, once the comments are posted on  The key messages of the comments are that this Proposed Rule:

(1) Exceeds FDA‘s authority and are contrary to the express provisions of the Food, Drug, and Cosmetic Act FDCA);

(2) Would lead to unwarranted confusion for healthcare providers and consumers, and as a result, put patients at risk;

(3) Is not supported by any empirical evidence that ANDA applicants have not complied with their regulatory obligations historically or that the incentives for them to comply with those obligations have been altered in light of recent United States Supreme Court decisions;

(4) Is based on a flawed premise that ANDA applicants routinely receive or possess data that may constitute newly acquired safety information alerting them to a need to propose safety-related changes to product labeling;

(5) Threatens to undermine the confidence consumers and healthcare providers have in generic drugs because they are the same as their brand-name counterparts;

(6)Would open the generic drug industry to massive and unwarranted state-law tort litigation and possible liability; and

(7) Would greatly increase the burdens on the generic drug industry and, therefore, would unnecessarily increase the costs of generic pharmaceutical products without an incremental benefit to patients. 

Moreover, GPhA says, FDA has not provided any objective evidence of a need to change existing regulations.

The comments echoed by many of the commenters to the Proposed Rule outline the statutory and regulatory position the Agency has held for over 30 years regarding the label “sameness” requirement and cites recent documents in which the FDA has stood firmly behind the notion that the generic product must bear the same labeling as the RLD to prevent confusion in the marketplace and to provide assurance to healthcare practitioners, patients and care givers that the generic product is as safe and effective as its brand name counterparts and are, therefore, fully substitutable.  Adopting the Rule as currently written will throw those concepts out the window and put generic manufacturers, patients, pharmacies and healthcare providers up the proverbial tributary without any physical means of propulsion.  In addition, it will leave in doubt whether any generic product is the same as another if all are permitted – even for a short period of time-to contain different safety information. 

GPhA points out FDA’s flawed reasoning that the Mensing Supreme Court decision somehow lessened ANDA holders’ incentive to conduct appropriate pharmacovigilance activities, but without any empirical evidence that this has actually occurred provided by the Agency.  GPhA also aptly notes that if the FDA believes that generic applicants are failing to meet the strict regulatory requirements for safety reporting, then they have enforcement tools to deal with those applicants that lag on their responsibilities, and not use new and unwarranted regulations to fix a problem that does not exist where such a fix would send the industry into chaos.

In addition, GPhA rightfully states the obvious that generic applicants do not have the safety database and receive only a small portion of the adverse event information and only for their product and not the for the same product of other manufacturers, so they are not in a position to judge the significance of isolated events.  The FDA, on the other hand, does see information from all manufacturers, and also has access to the entire safety database in the innovator’s application, and thus, is in a far better position to make accurate and relevant analysis and evaluation of potential safety information.   For these, among other reasons articulated in the GPhA’s comments, the comments conclude, “in short, the proposed rule imposes an undue and irrational burden—it would create an obligation to provide warnings that cannot be properly substantiated and that may run afoul of the misbranding requirements of the FDCA.”

So what is FDA doing here?  Is providing access to the courts an appropriate use of its regulatory authority?  I think not, and many join in my view.  GPhA says in its conclusions that ‘[T]he proposed rule is an attempt by FDA to provide people with a means to file lawsuits, a matter that should be of no concern to FDA. It strays from what should be a matter of concern to FDA furthering Hatch-Waxman‘s goals of making safe and effective drugs available to consumers at affordable prices. Patients and healthcare practitioners must continue to have access to consistent, transparent information in order to best inform treatment decisions. The FDA‘s rule as presently drafted would severely undermine those goals.”  Please seek out and read the full comments of GPhA and then speak to your Congressmen (and anyone else that will listen) and urge them to keep the 30 years of success of Hatch-Waxman in lowering associated healthcare costs and providing unfettered access of generic drugs to patient from being something of the past.  Remember the cost of this regulatory misstep will be borne by all of us!

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