Editor’s Note: Any FDA policies which result in Regulation by Litigation being used to resolve safety issues would be directly contrary to 3 mandates in the President’s Executive Order 13563, Improviding Regulation and Regulatory Review, which states that: 1) regulations “must be based on the best available science;” 2) regulations “must allow for public participation and an open exchange of ideas;” and 3) regulations “must promote predictability and reduce uncertainty….” By contrast to the Executive Order’s requirements, regulations which encourage litigation place science secondary to the vagaries of tort litigation, exclude the public participation in crucuial proceedings, and turn the outcome of the regulatory process into a litigious crapshoot.
From: The Pharma Letter
The US Food and Drug Administration says it plans to issue a proposed rule to revise FDA regulations about prescription drug labeling by September, a move that could open the generic drug makers up to liability if their drugs injure patients.
According to a description on the Office of Management and Budget’s (OMB) web site, the revised rule would create parity between brand-name pharma companies and generic drug manufacturers with respect to revising drug labeling to provide information about newly discovered risks.
The proposed rule comes shortly after the US Supreme Court ruled that generic drugmakers cannot be sued under state law for adverse reactions to their products (The Pharma Letter June 15). The court ruled that a state’s law cannot run against federal laws on prescription medications whose design has been approved by the FDA.
Senate Judiciary Committee Chairman Patrick Leahy (Democrat, Vermont) on Wednesday (July 3) welcomed the news that the FDA will move forward with a Notice of Proposed Rulemaking to ensure that generic manufacturers of prescription drugs can update their warning labels to provide better patient safety information to consumers.
Senator Leahy has long championed this public safety issue, following two Supreme Court cases in which patients who were injured by a prescription drug were unable to seek relief from the drug manufacturer because they took the generic version of the drug.
“A consumer should not have her rights foreclosed simply because she takes the generic version of a prescription drug,” Sen Leahy said, adding: “I welcome this first step by the Food and Drug Administration to address this troubling inconsistency in the law. Responsible brand-name and generic manufacturers alike should have the ability, and the obligation, to give doctors and patients the information they need to avoid injuries.”
Move also welcomed by Public Citizen
Welcoming the announcement, Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, noted that, when finalized, the revisions will fill a regulatory gap that poses a risk to patient safety.
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.
All drugmakers of given drug will be required to submit conforming labeling
The description on OMB’s web site 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.