·  Legal News, Analysis, & Commentary

Drugs & Medical Devices

FDA Re-opens Comment Period on Proposed Regulation Allowing Generic Drug Manufacturers to Initiate Label Changes

— March 30, 2015

The FDA held a public meeting on March 27, 2015 to hear new comments on a proposed regulation that would permit generic drug manufacturers to initiate labeling changes as new information about their products became available. In addition to the meeting, FDA also invited comment submission via electronic means as well as by snail mail. Comments must be received by April 27, 2015 to be considered.

This issue is, at heart, an attempt to prevent a repeat of the Reglan® incident, wherein label warnings were insufficient based on available data regarding the risk of tardive dyskinesia with long-term Reglan® use. The FDA approved the drug in 1980, but the manufacturer was not given a warning to update the label until 2009, despite evidence of the risk. The drug manufacturers did not alert the FDA of the risks.

In a comment to the FDA, Brandon Bogle of Levin, Papantonio, et. al. said:

What is most notable about the FDA’s action is that it was based on information that had been available for years, yet had not been adequately brought to the FDA’s attention by the drug manufacturers.  Indeed, the TD incidence data cited by FDA was the same 1992 Ganzini study discussed above and the 2006 Pasricha review of the literature citing that same study and another from 1993.  All of that information more easily could have been identified by the drug manufacturers, including the generic manufacturers, and brought to the FDA’s attention more than a decade earlier and well before many patients were made to needlessly suffer from this terrible disease.

Astonishingly, as our own Supreme Court has held, the current FDA regulations not only do not encourage generic drug manufacturers to bring important safety data to light, generic manufacturers are prohibited from unilaterally changing their drug labels to warn the public of such safety data.  Pliva, Inc. v. Mensing, 131 S. Ct. 2567, 2578 (2011).  Thus, under the existing regulations generic drug manufacturers were unable to warn the public of the significant risks of tardive dyskinesia with metoclopramide use until the branded manufacturer of Reglan first changed its label to include such information.

Should generic drug manufacturers be allowed to update their labels whether or not the brand name drug manufacturers do? The answer is a resounding “NO!” No, they should not be allowed to do so they should be required to do so!

Not all generic manufacturers are happy about this proposed regulation. The Generic Pharmaceutical Association says the regulation will result in widespread confusion as generics and name brands may have different labeling. It also argues that healthcare costs would rise by $4B if this regulation becomes effective.

As Paul Brown of The Patient, Consumer, and Public Health Coalition said in his comment:

The generic drug industry argues that their costs would increase, if they were held liable for harms (such as injuries or deaths) caused by their products. They also claim that having different warnings on generic drugs and brand name drugs would confuse patients. These claims are not credible. Prior to the 2011 Supreme Court case, generic drug makers were held responsible for failing to warn consumers and were [quite] profitable at the same time.

My thoughts? Boo hoo. You make a product the use of which carries some risks but you don’t want to warn of the risks or be liable to those harmed by your product? Perhaps you should stop taking whatever drugs you’re on and join us in the real world.

I sincerely hope that the FDA passes this regulation. Name brands and generics should be held responsible to their customers, not just their shareholders.


Federal Register

LegalReader – Justinian Lane

Levin, Papantonio – Brandon Bogle

Patient, Consumer, and Public Health – Paul Brown

Generic Pharmaceutical Association – Steve Arnoff

Join the conversation!