PDUFA goes to the president

It is finally done. The FDA user fee reauthorization bill has passed Congress and now only needs to be signed by President Obama. It kicks off a five-year stretch in which the FDA will have more money and new authorities in hopes that it will approve drugs faster (which is good for the industry) and theoretically cut costs for consumers and taxpayers through faster approval of generics.

The law will provide more than $6 billion in user fees over the five years and, for the first time, includes payments from generic drugmakers and those making biosimilars. The medical device industry has had its portion bumped up as well so that it, too, can get more of the agency's attention. It has provisions to help get orphan drugs to market faster and gives the FDA new authority to inspect foreign drug and ingredientmakers, and penalize them if they refuse. It is expected to save federal programs $311 million over 10 years.

But there are things it does not include, the Washington Post points out, such as a national track-and-trace system that FDA wanted for fighting counterfeit drugs by having the capability to track individual drug containers from manufacture to consumers' hands. The industry wanted a phased-in system, and when the two sides couldn't agree on how long that would take, it got left out entirely.

Still, the bill does a lot and provides the FDA with significant resources, paid by the industry, to fulfill its mission, points out John Manthei, former majority counsel to the House Energy and Commerce Committee and now a partner at the law firm of Latham & Watkins.

"Although some of the more controversial provisions were taken out of the bill during the final deliberations, the reforms that made it into the law will hopefully result in a more timely, transparent, and predictable FDA," Manthei says. "Only time will tell, but moving forward FDA is going to have a hard time arguing that it does not have sufficient resources to accomplish its mission."

- read the Washington Post story
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