Focusing the Lens on PDUFA V

Innovation is important.  This is especially true when it comes to new and innovative medicines that can save lives.  As we learned at the BIO International Convention last week, one way to encourage investment in new innovation and access for patients to newly created medicines is to streamline the regulatory process of the Food and Drug Administration (FDA). It is important that the FDA be an effective agency, which can only be guaranteed by policies that encourage timely decision-making and keep up with the regulatory science.

Last week at a FDA Town-Hall meeting at the BIO Convention, the FDA's Center for Drug Evaluation and Research's (CDER) Theresa Mullin discussed the complex issues the FDA faces as it navigates the highly complex regulatory environment, including its work to promote public health by ensuring the availability of new medicines as quickly as possible.  

As the complexity of science surrounding new medicines grows, so too does the need for the FDA to foster an innovative regulatory environment that encourages a timely approval process of new medicines. For instance, Mullin stated that the FDA must work to set new bio-marker qualifications for new medicines through clinical outcomes. What does that mean? Well, more advanced scientific research creates more complex medicines and these new medicines add new complexities to the regulatory framework.

Congress takes part in determining the regulatory framework for the FDA through the Prescription Drug User Fee Act (PDUFA). PDUFA was first created in 1992 to provide the FDA with a revenue source from user fees to help alleviate the backlog of drug applications and reduce the time for approval of a new drug.  While the mentality behind PDUFA has been to try and streamline the drug-review process, many challenges still remain. PDUFA must be reauthorized by Congress every 5 years and most recently was re-authorized for a fourth time in the "FDA Amendments Act of 2007." Remember, you can check out our Issues page for more information on PDUFA.

As it comes time again for re-authorization by Congress, PDUFA is again coming in to focus for law makers on the hill.  Tomorrow the Congressional Subcommittee on Health will hold a hearing entitled "PDUFA V: Medical Innovation, Jobs, and Patients" to discuss the issues surrounding the reauthorization of PDUFA.  We at LillyPad will do our best to keep you informed on the issues; look for live tweets and a blog post tomorrow to keep you up-to-date.