Prescription Drug User Fee Act (PDUFA) and Mobile Medical Apps

The Prescription Drug User Fee Act (PDUFA) authorizes FDA to collect fees from companies that produce certain human drug and biological products. PDUFA must be reauthorized in 2012. The House and Senate have passed their respective versions of "PDUFA V." The two bills, S. 3187, "The Food and Drug Administration Safety and Innovation Act” in the Senate and H.R. 5651, "Food and Drug Administration Reform Act of 2012". Of specific interest to AMIA and its members is that each contains language specifically relating to the regulation of mobile medical applications. In the Senate bill, Section 616 details what the FDA must do prior to issuing a final guidance on application regulation. The FDA would need to convene a working group of stakeholders and then submit a report to Congress. The Senate bill puts an 18 month "de facto moratorium" on rulemaking in regards to mobile medical applications. The House bill takes a broader look at health information technology, including mobile medical applications. In Section 773 of the House, HHS would be required to collaborate with the FDA, ONC and the FCC to submit a regulatory strategy to Congress within 18 months of passage. However, the House bill does not preclude FDA from issuing the mobile applications guidance. A reconciled bill is expected to be on the President’s desk by the end of June or early July. For more information see: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default....