Examining Concerns Regarding FDA’s Proposed Changes to Generic Drug Labeling


Hearing Description: The House Energy and Commerce, Health subcommittee recently met to examine a proposed a rule change to generic drug labels by the Food and Drug Administration. The witnesses were split on whether the proposed rule change is permissible by law. The proposed rule that would allow manufacturers of generic drugs to unilaterally change their safety-related labeling, deviating from the brand.

Hearing Date: April 1, 2014

Hearing Summary: Prepared for AAPS by the Market Institute

The Health subcommittee recently held a hearing to examine the FDA’s proposed changes to generic drug labeling. In his opening statement, Chairman Joe Pitts (R-PA) said the proliferation of generic drugs has been of the biggest medical successes of the last 30 years. Today, almost 85% of drugs dispensed are generic. In November 2013, the FDA issued a proposed rule that would allow manufacturers of generic drugs to unilaterally change their safety-related labeling, deviating from the brand. The only outcome from this ruling could be mass confusion. The FDA approved labeling would essentially become just “one in the crowd.” The rule change would contradict many existing rules and regulations as well as open generic manufactures to greater liability under state tort lawsuits.

The first witness, Janet Woodcock, Director at the Center for Drug Evaluation and Research, FDA testified in her opening statement that the proposed rule would speed the dissemination of new safety information about generic drugs to health professionals and patients by allowing generic drug makers to use the same process as brand drug manufacturers to update safety information in the drug product labeling. The proposed rule would create parity among application holders, with respect to these safety-related labeling changes, by permitting generic drug application holders to distribute revised generic drug labeling that describes newly acquired safety-related information. The proposal would ensure that the brand drug application holder for the corresponding brand drug is promptly advised of the newly acquired information that was considered to warrant the labeling change proposed for the drug in the CBE-0 supplement. The proposed rule, if finalized, is intended to improve the communication of important drug safety information about generic drugs to both prescribers and patients.

In response to questioning, Janet Woodcock said:

  • Innovator companies are concentrating on innovating, and in some cases are pulling drugs off the market because they can’t compete with generics
  • Physicians were not consulted in regards to this ruling nor any branded or generic drug companies
  • Drug labels need to be modernized, and they are looking at updating them on a global level
  • The thinking behind the rule is to create a level playing field between generic and branded manufacturers

The first witness on the second panel, Michael Shumsky, Partner at Kirkland & Ellis LLP testified in his opening statement that the success of the Hatch-Waxman Act, which has produced literally trillions in cost savings, is due to a simple, but brilliant, insight: Because two drugs with the same chemical and biological properties will have the same safety profile, FDA can safely approve generic copies of an already approved drug without requiring new clinical trials. FDA’s proposed ruling is indefensible. It pays no mind to Hatch-Waxman’s plain text, which explicitly requires generic labeling to be the same as the branded label. The proposal also ignores FDA’s own record on this issue. Indeed, FDA has recognized during every Administration in recent memory that generic labeling must be the same as the FDA-approved branded labeling.

The second witness on the second panel, Ralph Neas, President and CEO at the Generic Pharmaceutical Association testified in his opening statement that within one year after Hatch-Waxman became law, more than one thousand generic applications were submitted to the FDA. Generic drug companies proactively participate with the FDA in ensuring the timeliness, accuracy, and completeness of drug safety labeling in accordance with all current regulatory requirements. However, the proposed ruling would completely undermine the enormously successful Hatch-Waxman Act, and put both patient safety and health care savings at risk. The FDA’s proposal as drafted would create substantial confusion for pharmacists, doctors, nurses, patients and others in the health care system by allowing for multiple, different drug labels in the market for the very same product, upending 30 years of law and regulation.

The final witness on the second panel, Allison Zieve, General Counsel at Public Citizen testified in her opening statement her strong support for the FDA’s proposed rule change, which will bring post-market regulation of generic drugs in line with the realities of the pharmaceutical market today. While the objections to the proposal focus on liability, the purpose of the rule is to improve drug safety. The FDA cannot monitor all post-approval data by itself, drug safety is threatened when the regulatory and common-law incentives designed to motivate manufacturer diligence weaken with shifting control of market share. The FDA has structured the regulation to invite the brand-name manufacturer to submit a revision upon receipt of the generic labeling revision, to allow simultaneous review—with simultaneous approval or other response—of both the generic manufacturer’s labeling revision and the corresponding brand-name manufacturer’s revision.

Hearing Website

Links to Testimony

Panel I

Janet Woodcock, M.D., Director Center for Drug Evaluation and Research U.S. Food and Drug Administration

Panel II

Michael D. Shumsky Partner Kirkland & Ellis LLP

Ralph G. Neas President and CEO Generic Pharmaceutical Association

Allison M. Zieve General Counsel Public Citizen

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