Serious Questions Remain Regarding FDA Proposed Changes to Generic Drug Labeling

April 2, 2014

FDA Testimony Raises More Concerns Regarding Who Was Involved in Proposal, And Who Wasn’t

WASHINGTON, DC – Serious questions remain regarding the Food and Drug Administration’s proposed changes to generic drug labeling. Health Subcommittee members yesterday discussed the FDA’s proposed rule, following up on concerns outlined in a letter to FDA led by House Energy and Commerce Committee Chairman Fred Upton (R-MI). FDA’s proposed changes would reverse three decades of successful policy that was reinforced by the Supreme Court in 2011. Subcommittee members questioned why FDA is seeking the rule, who was involved in the decision-making, and how the change would affect patients, providers, and the cost of generic drugs.

“Both FDA’s legal and policy rationale for this change is dubious at best,” said subcommittee Chairman Joe Pitts (R-PA). “The only outcome I see if the rule is enacted is mass confusion. The FDA-approved labeling would essentially become just one in a crowd.”

“Simply, this proposed rule reverses years of successful practice and is built on questionable legal terms,” added Upton.

During the hearing, Rep. John Shimkus (R-IL) directly asked Janet Woodcock, FDA’s Director of the Center for Drug Evaluation and Research, who was involved in the decision-making process behind this proposed rule. Woodcock told Shimkus that FDA met with trial lawyers regarding the proposal, but did not meet with physicians, pharmacists, branded drug companies, or generic drug companies.

Click to watch.

Ralph Neas, President and CEO of the Generic Pharmaceutical Association, explained, “Disappointingly, the FDA’s proposal as drafted would create substantial confusion for pharmacists, doctors, nurses, patients, and others in the health care system by allowing for multiple, different drug labels in the market for the very same product, upending 30 years of law and regulation. This would not only jeopardize patient safety, but as a recent economic study has shown, would also create billions of dollars in annual increased costs for consumers, taxpayers, large and small businesses, and state and federal governments. The rule would decrease patient access, impede health care decisions and delivery, and make fewer generic drugs available.”

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