FDA Holds Hearing on Proposed Generic Drug Rule
April 13, 2015
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March 27, 2015: The FDA held a public meeting regarding its November 2013 proposed rule that would allow generic-drug manufacturers to update their product labels for safety reasons via the CBE-0 process, in advance of the reference listed drug manufacturer doing so. The FDA stressed that it would not further extend the current April 27, 2015 deadline for comments on the proposed rule.

Generic Drug Rule

Actions taken by generic drug manufacturers are limited by the current regulatory framework. Both generic-drug manufacturers and brand-name drug manufacturers must obtain FDA approval. However, a generic drug is required to maintain the same labeling as its corresponding brand-name drug (with some limited exceptions). The process through which labels are changed is via the Changes Being Effected (CBE) supplement process. Only brand-name manufacturers may use the CBE process. If the FDA approves a brand-name manufacturer’s label change, generic-drug manufacturers must make that same change to the corresponding generic drug’s label as soon as possible.

In a recent case, the Supreme Court found because the FDA prohibits generic-drug manufacturers from independently altering their labels to reflect newly acquired information about the effects of their drug, they cannot be liable for failing to make such changes. This ruling limited product liability plaintiffs’ remedies and generic manufacturer liability.


 Why is this a Problem for the Consumer?

Generic companies control a vast share of the market, approximately 84% of filled prescriptions, which creates a rather significant safety gap. The lack of accountability means generic companies have a lesser incentive to monitor their products. An individual or a family has few legal options to sue a pharmaceutical company for damages due to inadequate labeling if a drug is generic, while brand-name manufacturers can be held liable.

At the meeting, over 30 speakers presented their respective positions on the proposed rule to a panel of FDA representatives. The speakers included trade association representatives, consumer advocates, economists, and brand-name and generic-drug makers. Those speaking in favor of the FDA’s proposed rule included Public Citizen, several individuals sponsored by the American Association for Justice, attorneys representing plaintiffs in product liability suits, and others. Those who approve of the rule change expressed their belief that the FDA’s rule would advance safety by providing more incentives for generic drug companies to propose labeling updates, including by increasing civil liability for generic drug companies.

Senate Judiciary Committee Ranking Member Patrick Leahy (D-Vt.) Friday led a coalition of 28 lawmakers in a letter urging the U.S. Food and Drug Administration (FDA) to support consumers by adopting meaningful safety rules for labeling on generic drugs.

Make Your Voice Heard on this Issue

The meeting provided FDA with a lot to contemplate as the deadline for it public comment period approaches. This issue is open for public comment until April 27, 2015. Your questions, comments, and concerns can be submitted here. Regulators are often told to heed economic advice and opinion on legal interpretation. However, these considerations often divert the focus of the discussion from the very reason these regulatory bodies were created—to protect the people.  Ultimately, concerns for public safety should be the number one driving force behind agency action.