Senators Introduce PATIENTS' FDA Act and a Pediatric Drug and Device Act

April 17, 2012—United States Senators Tom Coburn (R-OK) and Richard Burr (R-NC) introduced the Promoting Accountability, Transparency, Innovation, Efficiency and Timeliness at Food and Drug Administration (PATIENTS' FDA) Act (S. 2292).

Also on April 17, United States Senators Jack Reed (D-RI), Lamar Alexander (R-TN), Patty Murray (D-WA), and Pat Roberts (R-KS) introduced the bipartisan Better Pharmaceuticals and Devices for Children Act (BPDCA; S.2289) that seeks to ensure that drugs and medical devices are specifically tested, labeled, and proven to be safe and effective for children. The Senators expect that the Senate Health, Education, Labor and Pensions Committee will consider the BPDCA bill this month.

According to the Senators Coburn and Burr, the PATIENTS' FDA Act will ensure that the FDA is promoting the public health through its review and regulation of medical products. They noted that the FDA's work on behalf of patients is supported not only by user fees, but also by taxpayer dollars. The PATIENTS' FDA Act is designed to complement proposed agreements negotiated between the FDA and the drug and device industries by ensuring appropriate transparency and accountability in the FDA's review and decision processes.

The complete announcement by Senators Coburn and Burr and a section-by-section summary of the proposed legislation can be reviewed online.

According to Senators Reed, Alexander, Murray, and Roberts, two key laws will expire on October 1, 2012, unless Congress passes legislation to renew them. The Pediatric Research Equity Act of 2003 requiring pharmaceutical companies to engage in pediatric studies resulted in a significant decrease of off-label drug use. The Pediatric Medical Device Safety and Improvement Act of 2007 led to a five-fold increase in small market devices designated for pediatric use.

The BPDCA would make these critical laws permanent, with the following improvements: ensuring pediatric studies are planned earlier in the drug development process; ensuring pediatric studies are completed; increasing transparency of completed, pending, and declined studies in children; and continuing the success of the pediatric medical device incentive and pediatric device consortia initiative. These goals are more fully summarized online in the Senators' announcement.