April 1 (Reuters) - The U.S. Food and Drug Administration onTuesday defended its proposal to require generic drugmakers toupdate the prescribing information on their products if theybecome aware of new safety information, a move the industry sayswill open them to product liability lawsuits and raise drugcosts.
Speaking at a hearing before a U.S. House of Representativeshealth subcommittee, Dr. Janet Woodcock, the FDA's toppharmaceuticals official, said the move is needed to "createparity" between branded and generic drug makers regardinglabeling changes.
Generic drugmakers are not currently allowed to alter thelabels on their products without prior agency approval sincegeneric drugs are supposed to be the same as their brand namecounterparts, from the active ingredient to dose strength to theinformation on the label. Any changes to the label must be madeby the branded company. Generic manufacturers are required tofollow suit.
The rationale goes back to the passage of the Hatch-Waxmanact of 1984, under which generic drugmakers were exempt fromhaving to conduct expensive clinical trials in humans if theycould show, based on laboratory tests, that their drugs were thesame as the branded drug that being copied.
The FDA for many years argued that in order to maintain the"sameness" concept, only brand companies should be able toupdate the labels.
But in 2011 the Supreme Court ruled that the FDA'sprohibition on label changes meant generic drugmakers should notbe held accountable for failure to warn against risk. As aresult, consumers taking a brand name drug can have legalrecourse if they are injured by a drug while those taking ageneric typically do not.
Now the FDA wants to unshackle generic drugmakers and allowthem to make such changes.
Today, more than 80 percent of prescriptions are written forgeneric drugs. In about 45 percent of cases the branded versionis no longer available, which means no company is responsiblefor updating safety data. Woodcock said the proposed rule wouldrequire both generic and branded manufacturer stand behind theirproducts.
"The goal is to make sure the whole system is searching forsafety problems and updating labels when they are found," shesaid.
The generic drug industry is lobbying aggressively againstthe proposal, and paints a dire picture if the rule were to befinalized.
"The proposed rule would expose generic drug manufacturersto substantial new tort liability costs, which in turn wouldrequire them to adjust prices to stay in business, withdrawproducts, or decline to launch new affordable versions of brandmedicines," Ralph Neas, president of the Generic PharmaceuticalAssociation told the committee.
Proponents of the measure say generic drugmakers will not betaking on any more liability than they did before the SupremeCourt ruling three years ago, and they note that prices did notgo down with the implied reduction in liability risk after thecourt's ruling.
"With greater ability to make prompt safety updates, theproposed rule should help avoid liability, as compared to thecircumstances prior to June 11," Allison Zieve, general counselat the drug safety watchdog Public Citizen, said. "The rule willhelp prevent injuries from occurring in the first place."
(Reporting by Toni Clarke in Washington; editing by Andrew Hay)