Feb. 28, 2014
Public Citizen Expert to Tell Lawmakers That Changes to Generic Drug Labeling Are Needed, Won't Increase Costs
Subcommittee Hearing Monday to Examine FDA's Proposed Changes to Generic Drug Labeling, Which Public Citizen Requested
WHAT: A new rule that would allow generic drug manufacturers to update warnings and precautions on product labeling would boost patient safety, Public Citizen will tell lawmakers on Monday. Allison Zieve, director of the Public Citizen Litigation Group, will testify Monday before the U.S. House of Representatives Committee on Energy and Commerce's Subcommittee on Health at a hearing to examine the U.S. Food and Drug Administration's (FDA) proposed changes to generic drug labeling. In August 2011, Public Citizen submitted a citizen petition (PDF) to the FDA to create the rule. The agency proposed such a rule in November 2013.
FDA rules prohibit generic manufacturers from updating product labeling even if they become aware of a potential risk not stated in the labeling. In contrast, the FDA allows brand-name manufacturers to update warnings on product labeling before getting FDA approval. The proposal would allow generic manufacturers to take advantage of the same procedures for updating labeling that are available to brand-name manufacturers. Generics now constitute the majority of all prescriptions filled, so generic manufacturers' inability to initiate labeling poses a threat to patient safety.
Generic manufactures have argued their cost would be greater if the rule changed, because they would be open to liability for harm to patients if they failed to provide adequate warnings about safety risks associated with their products. However, for all but the last three years, generic manufacturers have faced liability risk; until the U.S. Supreme Court's June 2011 decision in PLIVA v. Mensing, generic companies could be and were sometimes sued for failure to warn of risks posed by their products. So the proposed rule would not create a new cost. In fact, it would curb medical expenses incurred by injuries to patients, Zieve will explain. In this way the proposed rule will help avoid liability by preventing injuries from occurring in the first place.
WHEN: 2 p.m. EST, Monday, March 3
WHERE: 2125 Rayburn House Office Building, Washington, D.C. 20515
WHO: Allison Zieve, attorney, Public Citizen
Barbara Holzer, Broadcast Manager
w. (202) 588-7716
Karilyn Gower, Press Officer
w. (202) 588-7779