The fate of a new program designed to push generic drugs to drugstore shelves faster by levying fees on drug manufacturers is now in the hands of lawmakers. The FDA submitted recommendations to Congress Friday for a pair of consumer-focused prescription drug initiatives, including the Generic Drug User Fee Agreement.
The GDUFA could potentially be a big boon for consumers. As it stands, the review process for generic drugs is so fraught with regulatory and legal obstacles that it can take years for those cheaper drugs to ever reach stores.
The FDA would use a fee charged to drugmakers to help fund generic drug development and review. (See: CVS pays consumers $5 million to settle price gouging claims.)
“These final recommendations offer a great example of what can be achieved when the FDA, industry and other stakeholders work together on the same goal,” said FDA director Margaret Hamburg. “At a time of greater budgetary constraint, user fees provide a critical way for leveraging appropriated dollars, ensuring that the FDA has the resources needed to conduct reviews in a timely fashion.”
In exchange for the fee, the FDA promises to complete inspections of foreign and U.S.-based drugmakers by 2017, which it says will help cut back on review times. The agency reviews as many as 900 new generic drug applications annually. (See: U.S. Gov’t rejects prescription-free Plan B for minors.)
The program is a spinoff of the Prescription Drug User Fee Agreement, which levies a similar fee on brand name drugmakers in exchange for quicker review times and helps fund drug and research development.
The PDUFA is only good for five years and will expire in September if Congress doesn’t reauthorize it.
The Pew Health Group spoke out in support of the FDA’s recommendations:
“We commend the FDA and the pharmaceutical industry for working together on agreements that support the agency’s review activities,” said Allan Coukell, director of medical programs. “Under PDUFA, the FDA has reduced the time it takes to approve new drugs. Now thanks to the first ever agreement with the generic drug makers, industry has made an investment in greater oversight of U.S. medicines made overseas.”
But Pew pointed out that a regulatory agreement on the Medical Device User Fee Act has yet to be hashed out. Like the others mentioned, it would use fees applied to medical device makers to fund research and development in new products.