FDA reopens comment period on proposal for generic labeling changes

March 30, 2015

Should generic drug makers be required to update their drug labels about safety concerns before FDA reviews the change? Should this be done even if the information differs from the brand name drug labels temporarily?

Should generic drug makers be required to update their drug labels about safety concerns before FDA reviews the change? Should this be done even if the information differs from the brand name drug labels temporarily?

FDA held a listening session on March 27 to get more comments from stakeholders on its proposed rule introduced in November 2013. The comment period regarding proposed alternatives to FDA’s proposal ends April 27.

Under current law only brand name drug sponsors can add such information without an FDA decision.

But generic drugs now make up 86% of the market for outpatient drugs, Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, told participants at Friday’s session.

“Currently if a generic drug manufacturer believes that newly acquired safety information should be added to product labeling, they must notify the FDA and wait for the FDA to determine whether the label for both the brand and the generic should be revised, which may result in a delay,” Woodcock said.

FDA’s proposal would include the creation of a web page by the agency for information on label changes.

See also: Proposed new FDA rule might allow altered labeling of generic meds

Liability issues 

Overshadowing the discussion is the issue of companies’ liability for failure to warn patients about safety issues.

Supreme Court decisions in 2011 and 2013 held that generic drug makers can’t be sued for making a drug or for not warning about possible risks because the companies legally may not have warnings that differ from the brand product.

The day-long session saw a number of emotional moments during testimonies from people who had horrific injuries or who had lost babies as a result of generic drug adverse events.

See also: Planned FDA guidance on drug labeling seeks to help reduce medication errors

 

Stakeholders oppose proposal

However, the American Society of Health-System Pharmacists (ASHP), the Academy of Managed Care Pharmacy, the American Pharmacists Association, and others have submitted testimony opposing the rule, saying it may lead to confusion and it would raise costs.

ASHP said it is concerned about whether the agency can implement the rule effectively to ensure that everyone can access complete information regardless of the labeling source. “FDA has historically faced challenges with maintaining consistent and current prescription drug labels,” according to ASHP.

But a number of consumer groups testified in favor of FDA’s proposal on the grounds of having manufacturers take responsibility for their products. Rachel Weintraub, legislative director and senior counsel for the Consumer Federation of America, said the rule is now overdue.

Several witnesses in favor of the agency’s proposal had their travel expenses paid by the American Association of Justice, which was formerly the Association of Trial Lawyers of America.

On the other side, a number of witnesses, including some representing minority groups, also said that the proposal would raise the cost of medications. One economic study, touted by the Generic Pharmaceutical Association (GPhA), suggested that FDA’s plan would increase drug costs by $4 billion but other testimony criticized its methodology.

The FDA panel at the session repeatedly asked representatives of drug manufacturers if they had liability insurance, and several said yes.

Generic drug companies argued that often they only have a portion of the market for a drug and are not in a position to see or understand safety signals. On the other hand, brand companies argued that their market share often drops precipitously after generics come on the market, and they may not be able to have the best information about safety, either.

FDA responsible for timeliness

Last November the GPhA and the Pharmaceutical Research and Manufacturers of America came together to propose that FDA itself be responsible, under defined time parameters following receipt of safety information, to decide on label changes. They argued that only the agency has all the information about a drug to make decisions about labeling.

FDA’s Woodcock said the need for specific information about a drug is heightened with the advent of personalized medicines. And she said, it is extremely common for information about additional risks or more information about known risks to become apparent in the post-marketing environment.