Editorial: Congress “should not dillydally” on PDUFA
The Washington Post recently ran an editorial in support of the timely reauthorization of the Prescription Drug User Fee Act, also known as PDUFA. It’s worth a read:
FOR ABOUT 20 years, the Food and Drug Administration (FDA) has charged pharmaceutical companies “user fees” for reviewing drug-approval applications. The revenue allows the FDA to hire more evaluators, which allows useful drugs to reach patients faster. Now the Prescription Drug User Fee Act needs reauthorization, as it does every five years. Legislators should not dillydally.
The bill accounts for more than half of the FDA’s drug-approval budget. Critics fret that this dependence could make the FDA beholden to those it regulates. But there’s been no evidence of that, and the risk clearly does not outweigh the benefits of faster approval times — to patients and to companies motivated by profit to develop life-saving treatments.
Congressional reauthorization has been an occasion to renew the perennial debate over the balance between safety and speed, between ensuring that new drugs will have no unintended consequences and getting helpful treatments to sick people as quickly as possible. This time around, the balance appears to be tilting slightly toward faster approval. That’s good.
As we have noted previously, PDUFA paid for $573 million in drug review costs in fiscal year 2010. That accounts for 62 percent of the review costs for that year, according to the FDA’s most recent PDUFA financial report.
The law, however, is set to expire and must be reauthorized by September.
Because AstraZeneca stands for programs that work and a strong, well-funded and well-managed FDA, we support a timely reauthorization of PDUFA that provides much needed resources to the agency.
We hope that the resulting legislation will lead to a more efficient, predictable, transparent and well coordinated drug review process within the FDA while strengthening the scientific base at the agency, supporting patient safety and promoting innovation.