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A controversial FDA proposal to alter the process for making changes to approved drug labels has drawn stiff opposition from industry, support from consumer advocates and trial lawyers, and pressure from Congress for the agency to resolve the issue. FDA acted two years ago in response to several high court rulings, issuing a new policy in 2013 that permits generic drug makers to revise product labels when they become aware of important new safety information. That represents an important change from current policy, which makes brand marketers responsible for postmarketing label changes, with generics makers following the innovators’ lead. FDA says its new rule would provide generics firms with “the same opportunity as brands” to independently update and distribute new safety information, explained Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), at an FDA public meeting last week, held to hear comments from all interest groups on what has become a highly contentious issue.

But industry executives urged FDA to adopt an “expedited agency review” (EAR) alternative to the proposed rule. Under the EAR program, all manufacturers would submit important new safety information to FDA for agency review and a decision on what labeling changes are warranted. Then all marketers would revise labels as indicated by FDA within 30 days. The proposal also clarifies that generic drug makers may update labels after the reference listed product exits the field. And brands would still be responsible for proposing label changes where there is no generic competition.

Generics drug companies have championed this approach to avoid having product labels with differing safety information that would confuse prescribers and patients, as manufacturers predict would occur under FDA’s proposal. The Generic Pharmaceutical Association (GPhA) also claims that FDA’s proposal undermines the Hatch-Waxman Act’s key principle of “sameness” that is basic to maintaining public confidence in the quality and safety of generic products. And the FDA rule would increase industry costs by some $4 billion a year due to greater liability exposure and added record-keeping and regulatory requirements, according to a GPhA study released in February.

While the Pharmaceutical Research and Manufacturers of America (PhRMA) does not object to the FDA rule, it also supports the industry alternative plan as a way to ensure that innovator and generic drugs have similar labeling information that promotes correct prescribing and safe drug use. The main goal is to for FDA to “complete rulemaking expeditiously,” said PhRMA vice president Jeffrey Francer at the public meeting – and adopting the EAR approach seems the most efficient approach.

Consumer groups and trial lawyers, however, strongly support the FDA proposal as a way to make generic drug firms more responsible for providing appropriate safety information on their products. At the public meeting, several individuals provided chilling details on the harms suffered from poorly labeled generic medicines, including Sharon Levine of the seminal Wyeth v. Levine case of 2008. Their testimony was supported by the trial lawyers’ American Association for Justice (AAJ), which insists that generic drug companies should be equally liable as brand firms for failure to warn of potential harm related to their products. Michael Carome, director of Public Citizen’s Health Research Group, maintained that the FDA proposal would not lead to different, confusing labels and that it does not undermine the “sameness” requirement. An AAJ report refutes GPhA claims that the FDA proposal would increase costs, although several health organizations representing minority groups opposed the rule on the basis that it would make generic drugs unaffordable to low-income individuals.

A problem for FDA is that industry’s alternative plan imposes a sizeable and costly new burden its staff, a concern that could be alleviated by increasing drug user fees. And requiring FDA prior approval of safety labeling changes could be slower than the current changes-being-effected (CBE) approach for innovator postmarketing label changes.

FDA is under pressure to decide the issue by October, and will stop accepting comments at the end of April. Manufacturers would like fast action, as some generics firms face liability claims from individuals taking their cases to state courts. Woodcock noted the need for a “uniform, functional process” that ensures access to generic drugs and provides prescribers and patients with the most up-to-date information on drug risks.

Mar 30, 2015
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