FDA Rule on Generic Drug Labeling Faces Hearings This Week Amid Industry Pressure

U.S. lawmakers are planning to take a close look this week at proposed regulations that may reverse a prior Supreme Court ruling, which has shielded generic drug makers from liability for failing to warn consumers and doctors about potential risks associated with medications they sell.

A congressional briefing is scheduled for Thursday, to review the FDA’s proposed rule that would allow generic drug manufacturers to update label warnings when they learn about new risk information. However, the pharmaceutical industry has been pressuring the agency to water down the rules, in hopes that they will be able to maintain essential immunity from failure to warn lawsuits.

In recent years, generic drug makers have successfully defended cases brought by patients who suffered injuries from known risks associated with their medications, even when the warning labels failed to adequately warn about the potential side effects.

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Known as federal pre-emption, the generic drug makers have argued that they are insulated from liability since existing FDA regulations prevent them from independently updating the warning labels, requiring that the copy-cat drugs they sell carry the same warnings provided on the name-brand versions.

In a controversial 2011 ruling, the U.S. Supreme Court upheld this defense in a case known as Pliva v. Mensing, which found that since it was impossible for generic drug makers to comply with the federal regulations and state warning requirements, lawsuits over failure to warn are barred against generic manufacturers.

The rule change currently proposed by the FDA will likely change this, and largely negate the preemption argument by generic drug makers, allowing them to update labels when they learn of risks associated with their medications.

The prominent consumer watchdog group Public Citizen has called for the FDA to hold the line on the proposed rule, but warns that industry pressure has already led the FDA to accept more comments on the proposed rule, even after the submission deadline of March 13. The FDA is also holding a public hearing on Friday to look at an industry counterproposal.

Public Citizen indicates that the alternative proposal is bad for patients, because companies would not be required, nor have any incentive, to update the labels when new safety problems are discovered. The group also points out that it leaves no one accountable for injured patients when drug manufacturers fail to warn patients about newly discovered risks and would significantly slow down the labeling updates.

Public Citizen first called for the new rules in 2011, calling for the agency to amend the federal regulations that limit generic drug makers’ ability to update warning labels. The group indicated that the outdated regulations prevent consumers from learning about many known risks associated with generic drugs and has become a shield for pharmaceutical companies against product liability lawsuits.

The congressional briefing will be held at 4:30 p.m. on March 26 in Room 2103 of the Rayburn House Office Building in Washington, D.C. The FDA public hearing is slated for March 27, starting at 8 a.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (room 1503), Silver Spring, Md.


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