(PRWEB) August 26, 2015
The fourth Medical Innovation Impact Index (MI3) Alert considers the 2017 reauthorization of both PDUFA and MDUFA (Medical Device User Fee Amendments) for which discussions and hearings are being scheduled. User fees received a score of -3 (range -10 to +10) for their impact on medical innovation by the Initiative for Patient Centered Innovation (iPCI) of Fairleigh Dickinson University’s (FDU) Rothman Institute of Innovation and Entrepreneurship.
The purpose of user fees is to provide additional funds to the FDA to process new product applications more expeditiously. PDUFA and MDUFA established target time frames within which new products are to be reviewed. Unfortunately, FDA performance is not in line with the review time frames established by user fees. For example, in 2013, the median approval times for drugs was 304 days – this means that approval times exceed the PDUFA goal of 10 months for 50% of applications.
Moreover, in an effort to meet review deadlines, at least for some new products, PDUFA amendments have ushered-in a rapidly-expanding series of regulatory incentives for niche areas of “high unmet medical need.” This has created a very disjointed, cumbersome, and exploding body of law for FDA reviewers and drug developers to master. Without proper time for these to mature and settle-into practice, great uncertainty and inconsistency with respect to their application has ensued. Worse, drug developers are preferentially directing their efforts to niche diseases to avail themselves to the regulatory incentives contained in PDUFA, neglecting other diseases that affect huge populations of patients. This is not helpful to medical innovation and not good for patients.
The Medical Innovation Impact Index (MI3) is a succinct, real world analysis and scoring system based on interviews with legal and medical experts who interact with government agencies regularly in the review of new products in development. The purported benefits and potential positive impacts on medical innovation are listed and scored zero to +5, based on the likelihood of achieving these objectives; the unintended consequences and potential negative impacts on medical innovation are listed and scored 0 to -5, based on the likelihood of these untoward effects happening. A final composite score (ranging from -10 to +10) is calculated and a recommendation is provided.
Currently, no analysis exists to evaluate rules solely with respect to their impact on the advancement of medical innovation, which is the purpose of the Medical Innovation Impact Index. MI3 alerts will be issued monthly.
About Fairleigh Dickinson University
Devoted to the preparation of world citizens through global education, Fairleigh Dickinson is New Jersey's largest private university and features more than 100 liberal arts and professional degree programs, two international campuses, dozens of partnerships with internationally renowned institutions and special programs and status within the United Nations.