The Urgency of PDUFA

  • by: Peter Pitts |
  • 06/20/2017
From today’s edition of the Daily Caller …

Patients Will Die If Congress Doesn’t Reauthorize This 25-Year Old Law

Thousands of Americans could die waiting for the FDA to approve new, lifesaving treatments if Congress fails to reauthorize a 25-year old law this summer.

The legislation, the Prescription Drug User Fee Act, charges pharmaceutical companies in order to fund the FDA. Without this legislation (renewed every five years), the FDA wouldn’t have the resources to review and approve new medicines in a timely manner. Patients would lose access to new, innovative drugs, thousands of FDA scientists would lose their jobs, and pharmaceutical companies would scale back medical research.

PDUFA, which first became law in 1992, requires pharmaceutical companies to pay the FDA to review new drug applications. The law also requires the FDA to review 90 new drug applications in a predictable, timely manner.

This mandate — and the funding from “user fees” — has greatly sped up the review process for new drugs. Prior to PDUFA, the FDA generally took at least two years to review new medicines. Foreign countries approved 70 percent of new drugs before the United States did.  American patients were getting sicker — and often dying — waiting for FDA officials to approve medicines that had already been deemed safe and effective by European regulators.

PDUFA has cut the average review time for new drugs from 30 months in 1991  to under 12 months in 2016.  It has helped bring more than 1,500 new drugs to pharmacy shelves.

The law makes medicines cheaper for consumers by increasing competition amongst drug companies. Take the new class of drugs used to cure hepatitis C. In 2013, there was only one cure on the market — and it cost $1,000 per pill. But the FDA approved competing products the following year. The ensuing price war forced drug companies to slash prices by 40 to 50 percent to gain market share.

PDUFA expires this fall. If Congress fails to reauthorize it, we’d revert to a time when drug approvals took years. Some patients battling serious illnesses could die waiting, and all patients would face higher costs due to less competition.

Patients aren’t the only ones who would suffer from congressional inaction. As Senator Lamar Alexander (R-Tenn.) explains, “If we do not move quickly to reauthorize these agreements, in late July, the FDA will be forced to begin sending layoff notices to more than 5,000 employees to notify them that they may lose their job in 60 days.”

Scientists and workers in the private sector could lose their jobs too. Quick drug approvals give pharmaceutical companies more time to sell their inventions before patents expire. That makes drug development a more attractive investment.

Timely approvals give companies confidence to hire new workers and plow money into research, growing the economy. Already, the pharmaceutical industry directly employs 850,000 people and indirectly supports another 3.5 million jobs. The sector contributes a staggering $1.2 trillion in economic output.

Patients, FDA scientists, and drug industry employees would all suffer if Congress lets PDUFA expire. The law has been an unqualified success — and deserves a speedy renewal.

Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest. 

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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