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Letter to Margaret Hamburg, Commissioner of the Food and Drug Administraation - FDA's Proposed Change to Generic Drug Labeling Policy

House and Senate Lawmakers Say the Proposed Change Would "Conflict Directly" With Settled Law, Create Confusion, and Impose Higher Drug Costs on Patients

House Energy and Commerce Committee Chairman Fred Upton (R-MI), today led a group of House and Senate Republican lawmakers in sending a letter to Food and Drug Administration (FDA) Commissioner Margaret Hamburg expressing concerns about the FDA's proposed regulation to allow generic drug companies to unilaterally change their drug labeling information, saying "such a rule would conflict directly with the statute, thwart the law's purposes and objectives, and impose significant costs on the drug industry and healthcare consumers."

"It is important that we fully understand how FDA came to this decision and what impact the agency believes such an approach would have on patients and providers," commented Upton. "For years, the 'sameness' requirements have made it easier for both patients and providers to understand the benefits and risks, providing peace of mind and encouraging competition in the generic drug market. The proposed changes by FDA raise a number of concerns and potentially significant costs that FDA needs to explain to Congress and the American people."

The letter says: "We are writing to express grave concerns regarding a regulation … that would change longstanding policy regarding the 1984 Hatch-Waxman Act. The proposed regulation would allow generic manufacturers to alter an abbreviated new drug application (ANDA) label without the FDA's prior approval. We strongly believe that such a rule would conflict directly with the statute, thwart the law's purposes and objectives, and impose significant costs on the drug industry and healthcare consumers. We respectfully request the Agency explain and reconsider this departure from more than two decades of settled practice."

The Hatch-Waxman Act requires generic drug products to be materially identical to their brand-name counterpart--including the drug label. The lawmakers also noted that chemically equivalent drugs with different warnings and safety information will not only be confusing to patients and prescribers, but the increased regulatory burdens of the proposed rule will increase the costs of generic drugs.

The letter continues: "The FDA's proposed rule is not only inconsistent with the sameness requirement in the text of the Hatch-Waxman Act, it also threatens to undermine the law's purpose. As the FDA itself has recognized, "Consistent labeling will assure physicians, health professionals, and consumers that a generic drug is as safe and effective as its brand-name counterpart.' Allowing generic manufacturers to unilaterally change their labeling means potentially dozens of drugs that are chemically and biologically identical might nonetheless bear different safety information, confusing patients and prescribers alike."

The following members of Congress signed the letter: Senators Alexander, Mike Enzi (R-Wyo.), Richard Burr (R-N.C.), Johnny Isakson (R-Ga.), Orrin G. Hatch (R-Utah), Pat Roberts (R-Kan.), Lisa Murkowski (R-Alaska), Mark Kirk (R-Ill.), Tim Scott (R-S.C.), and Tom Coburn, M.D. (R-Okla.); and U.S. Representatives Fred Upton (R-Mich.), Marsha Blackburn (R-Tenn.), John Shimkus (R-Ill.), Joseph R. Pitts (R-Pa.), Greg Walden (R-Ore.), Tim Murphy (R-Pa.), Michael C. Burgess, M.D. (R-Texas), Bob Latta (R-Ohio), Steve Scalise (R-La.), Phil Gingrey, M.D. (R-Ga.), Mike Rogers (R-Mich.), Gregg Harper (R-Miss.), Bill Cassidy, M.D. (R-La.), Pete Olson (R-Texas), David McKinley (R-W.Va.), Adam Kinzinger (R-Ill.), Gus Bilirakis (R-Fla.), and Bill Johnson (R-Ohio).

Letter only available in PDF format, please see source to view document.

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