FDA to Give Generic Drug Industry More Time to Comment on Proposed Labeling Regulation

| 19 December 2013 |  By 

The US Food and Drug Administration will allow an additional two months for members of the pharmaceutical industry and the public at large to comment on a proposed regulation that would make it easier for generic pharmaceutical manufacturers to temporarily update the labeling on their products to reflect new safety risks.


Under the Federal Food, Drug and Cosmetic Act (FD&C Act), a generic drug product must-with minor patent-related exceptions-adhere exactly to the FDA-approved labeling borne by the drug it references in its 505(j) application, otherwise known as an abbreviated new drug application (ANDA).

In theory and practice, this is to ensure that generic drug manufacturers don't seek to take shortcuts in the drug approval process, or downplay safety risks associated with a drug. But it has also meant that some generic drug manufacturers, aware of rare safety risks not currently reflected in the labeling, have been unable to update their own labeling.

This has left them open to legal challenges, the most notable of which have been the Supreme Court cases of Mutual Pharmaceuticals v. Bartlett (2013)and Pliva v. Mensing (2011).

The Bartlett case involved a plaintiff who was prescribed the generic NSAID Clinoril (sulindac) to treat shoulder pain. Clinoril was manufactured by Mutual Pharmaceutical. Soon after taking the drug, the plaintiff suffered what the court described as an "acute case of toxic epidermal necrolysis," severely and permanently disfiguring and nearly blinding her.

Notably, the label did not include a warning about the possibility of the condition that the plaintiff suffered. Lower courts found Mutual guilty of a "failure to warn" charge, and awarded the plaintiff $21 million in damages. However, the Supreme Court overturned that ruling, saying that generic companies were under no such obligation to either warn or remove their products from the market.

The case was widely seen as further enforcing the Mensing decision, which came to a similar conclusion in a similar case.

The Rule: Basics

In the wake of those cases, FDA released a proposed rule that would allow generic pharmaceutical manufacturers to update their labels immediately using the Changes Being Effected (CBE) zero-day notification process (CBE-0).

In layman's terms, that means that generic companies would be able to update their labels to reflect new safety changes as soon as they were aware of a risk, but they would then immediately need to notify FDA of the labeling change. The agency would then work to harmonize the labels of the generic drug, the reference-listed drug (RLD) and any other generic drugs on the market. Any changes would eventually affect both the generic and RLD owners' labeling, FDA explained.

For a complete background on the rule, please see Focus' November 2013 article, "FDA Proposed Groundbreaking Overhaul of Generic Drug Labeling Regulation."

Intense Scrutiny

The rule has been already been subject to intense scrutiny.

At the time of the rule's release, the US Chamber of Commerce observed that it could subject generic drug manufacturers to "failure to warn" lawsuits, making the sector financially unappealing to manufacturers who already operate on small profit margins. The move could increase the cost of drugs to consumers while adding few benefits, the Chamber argued.

It also remains unclear how FDA would handle drugs where an issue is identified, a CBE-0 is submitted, but the agency declines to make a change. Would the drug need to be removed from the market, and would the drug be subject to failure-to-warn claims if it remains on the market?

And that may be just the tip of the iceberg. As Focus reported on 15 November, several legal and generic drug experts have questioned if the regulation is legal at all.

Additional Time

For its part, FDA seems aware of the deluge of comments set to challenge the rule. While it had originally set a 60-day comment period that was set to end in early January 2014, it has announced that it will extend the comment period until 13 March 2013-an additional two months.

"This extension is being provided in response to requests to provide interested persons with additional time to submit comments," FDA explained on its website. "FDA is expediting publication of a notice in the Federal Register to extend the comment period."

The notice is somewhat unusual in that FDA is extending the comment period before the existing one had ended. It most often extends the comment period after the existing one has ended.

FDA Comment Extension Notice


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