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Pharma Power Stumbles on FDA User Fee Vote

Statement of Peter Maybarduk, Director, Public Citizen’s Access to Medicines Program

WASHINGTON - Note: Yesterday, the U.S. Senate voted, 94-1, to approve a five-year reauthorization of U.S. Food and Drug Administration (FDA) user fee programs that fund the agency’s drug and medical device reviews. The pharmaceutical industry had lobbied the U.S. Senate to include the pharma-backed Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2017 (OPEN) in its approval, which would have extended marketing exclusivities on all uses of medications that have been approved in part to treat rare diseases. A Public Citizen report found that the OPEN Act could cost taxpayers and consumers up to $11.6 billion over 10 years.

For years the prescription corporations have exploited every legislative opportunity to expand their monopoly power and raise prices on Americans struggling to afford medicine.

Yesterday, Big Pharma’s power stumbled in what may become a turning point in the fight for affordable medicine for all.

By excluding pharma’s OPEN Act from the user fee reauthorization, the Senate is saying no to the pharma lobby and to longer, exorbitantly-priced monopolies on medicines, and saying yes to the American people – 75 percent of whom favor shortening the length of monopoly granted on prescription drugs. 

The next step is to pass meaningful prescription price reform, such as the Affordable Meds Act (S. 771) and the Stop Price Gouging Act (S. 1369).


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Public Citizen is a national, nonprofit consumer advocacy organization founded in 1971 to represent consumer interests in Congress, the executive branch and the courts.

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