How to prevent further decline in lifesaving drug approvals
The FDA approved just 22 new medicines last year — the lowest number in six years.
Approval numbers could fall even further if Congress fails to reauthorize the Prescription Drug User Fee Act (PDUFA). By speeding up the approval process, PDUFA helps lower drug prices and save patients’ lives.
Congress passed PDUFA in 1992 as a way to hasten the drug approval process. The act allows the FDA to collect millions of dollars in fees from pharmaceutical companies. These fees provide the FDA with the financial resources it needs to swiftly evaluate experimental medicines and determine if they’re safe and effective enough for sale. The law must be renewed every five years, and it’s up for reauthorization this fall.
If Congress does not reauthorize PDUFA, the FDA will lose an indispensable funding tool. Each year, the FDA collects at least $718 million in user fees — approximately 15 percent of the agency’s total budget. These fees have enabled the FDA to hire extra staff, boosting the number of drug reviewers by 77 percent in the first nine years following PDUFA’s enactment.
The extra reviewers shortened drug approval times, as intended. Before PDUFA, it took the FDA more than 30 months, on average, to approve a drug. Today, the FDA approves drugs in less than 10 months. Since its enactment, PDUFA has helped the FDA approve more than 1,500 new drugs.
Faster drug approvals not only help lower pharmaceutical costs but also allow essential lifesaving medicines to patients in need. In one study, a Tufts researcher examined the prices of 20 drugs introduced to compete with existing drugs. He found that the majority of these drugs were launched at lower prices.
One new high blood pressure treatment, for example, sold for 68 percent less than the incumbent treatment. The enhanced approvals provide treatment options to physicians while allowing competitive wars for market share between rival drug makers, inevitably driving prices down.
Other nations are trying to copy PDUFA’s success. The United Kingdom recently established the Office for Market Access, which collects fees from the pharmaceutical industry to speed up reviews of drugs and medical devices.
It’d be a sad irony if Congress fails to reauthorize PDUFA at the same time other countries are clamoring to implement their own versions.
Before PDUFA’s enactment, some critics worried that the FDA’s dependence on user fees would cause regulators to approve medicines of questionable safety and efficacy.
But the opposite has occurred — the FDA now approves fewer medicines that ultimately prove defective. An MIT analysis found that between 1980 and 1992, 2.81 percent of FDA-approved drugs were later pulled from the market due to safety concerns. That share declined to 2.21 percent once PDUFA became law, a decline of nearly 25 percent.
The FDA needs adequate financial resources to quickly and thoroughly review new medicines. Reauthorizing PDUFA would provide that revenue, thereby expanding the number of medications available to patients and driving down drug prices.
Sandip Shah is the founder and president of Market Access Solutions, a global market access consultancy, where he develops strategies to optimize patient access to life-changing therapies. Joe Black is director at Market Access Solutions.
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