Statement of Sidney Wolfe, MD, founder and senior adviser, Public Citizen’s Health Research Group
We are extremely pleased to see that the Food and Drug Administration (FDA) on July 3 announced its plan to issue a proposed rule to revise FDA regulations about prescription drug labeling. When finalized, the revisions will fill a regulatory gap that poses a risk to patient safety.
According to a description on the Office of Management and Budget’s (OMB) website, the revised rule would create parity between brand-name drug manufacturers and generic drug manufacturers with respect to revising drug labeling to provide information about newly discovered risks.
Under current FDA regulations, generic manufacturers cannot update their products’ labeling, even if they become aware of a potential risk not stated in the labeling. In contrast, brand-name drug manufacturers can update warnings and precautions before getting FDA approval.
Almost two years ago, in August 2011, Public Citizen submitted a citizen petition to the FDA asking it to revise its labeling rules to fill the safety gap. The FDA’s proposal suggests that the agency plans to grant that petition.
The description on OMB’s website also states that the FDA’s new proposal would address requirements that all manufacturers of the same drug submit conforming labeling revisions after the FDA has approved a revision by one manufacturer of that drug.
Many potential hazards are not discovered until years after drugs have been on the market, as documented in a recent Public Citizen report, yet, currently, generic drug manufacturers can do little to warn doctors and patients about newly discovered information, putting patients at risk.
The proposed rule is a classic example of harm reduction. When finalized after public comments, it will provide added protection to the tens of millions of people who regularly use generic drugs.