As we've stated many times, it's not just enough that Congress reauthorizes PDUFA; they must pass a clean PDUFA, free of extraneous additions that bring new costs and burdens to the FDA. Congress' goal should be to create and promote a regulatory system where the FDA has the tools and resources necessary to deliver safe, effective new cures and treatments to patients as quickly as possible. The best way to achieve this is by passing a clean PDUFA.
In the past, unnecessary additions to PDUFA reauthorization bills have slowed down new drug approval by shifting resources away from what's needed to bring new, safe medicines to market quickly. And we have reason to be concerned that this Congress views this PDUFA reauthorization as a vehicle for new policies and regulations not associated with new drug review. As this article in the National Journal mentions, PDUFA (and the similar Medical Device User Fee Agreement, MDUFA) "will almost certainly attract political amendments that could slow them down." From the article:
The biggest health care task looming over Congress in 2012 is the reauthorization of programs that direct more than $1 billion in fees from the pharmaceutical and medical device industries to the Food and Drug Administration.So what do we mean by a "clean" PDUFA? To understand that better, we need to take a look back at the technical letter negotiated by the FDA, industry representatives, and patient groups last year. The letter, which you can read more about in this post, contains important provisions on everything from improving communication between the FDA and drugmakers, to enhancing patient safety through a better benefit-risk assessment structure, to investing in the development of medicines for rare diseases. When the FDA held a public meeting on PDUFA reauthorization after the release of the technical letter, we were happy to hear many voices endorsing the letter and recognizing that agreement reached between all stakeholders will help ensure that the FDA will be able to deliver innovative new treatments and cures to patients in a timely manner. CMM fully agrees with this position. To us, a clean PDUFA reauthorization is one where Congress does not alter the technical letter already endorsed by patients, health care professionals, and industry groups, and does not add unrelated provisions that will only hinder the FDA.
The FDA uses the money to cover the cost of ensuring that new products are safe and effective. The current programs expire in in September, making the Prescription Drug User Fee Authorization, or PDUFA, and the Medical Device User Fee Authorization, or MDUFA, "must-pass" legislation. Without the fees from private industry, the FDA cannot continue approving new devices.
By providing the FDA with the resources it needs to tackle the modern challenges facing the biopharmaceutical sector, PDUFA also makes sure that the U.S. remains the global leader in discovering and delivering these new, lifesaving cures and treatments. Congress should keep in mind that the heart of PDUFA is patients, not politics--and making unrelated legislative additions to the bill will only delay innovative medicines from getting to the patients who need them.