Markey Supports FDA Reform Act, Calls for Action on Medical Device Reform

FDA package doesn’t address safety loophole in flawed medical device approval process
WASHINGTON, D.C. – Congressman Edward J. Markey (D-Mass), senior member of the Energy and Commerce Committee, today praised the Food and Drug Administration (FDA) Reform Act of 2012, which included provisions he authored to improve access to treatments for rare diseases, ensure that drugs intended for children are tested and labeled appropriately, and promote the development of medical devices for children. However, the legislative package does not include any provisions to address the faulty FDA approval process that enables defective medical devices to be implanted in patients, which has caused serious injury and death. In February, Rep. Markey introduced H.R. 3847, the Safety Of Untested and New Devices (SOUND Devices) Act to close a major loophole in the device approval process and allow FDA to reject a device if it is based on an earlier product that had to be recalled from the market for causing serious harm to patients.
“This bill must not be the last word on medical device safety,” said Rep. Markey “While this important legislative package contains several provisions that I have authored, I am disappointed that it misses an important opportunity to vastly improve the safety of medical devices and protect patients from serious harm. I hope my colleagues will join me to close this loophole so that we can keep the American public safe from harmful medical devices.”
The final FDA User Fee Act package includes the following provisions authored by Rep. Markey:
•                     H.R. 4156, the Expanding and Promoting Expertise in the Review of Rare Treatments (EXPERRT) Act of 2012, provides researchers, academics, patient advocates, and other rare disease experts a larger role in FDA’s review of new rare disease treatments. The EXPERRT Act provides support for reviewers at the FDA who are being asked to review a growing pipeline of very specialized treatments.
•                     The bipartisan Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) makes significant improvements to the laws to increase the number of studied medications available for children that would help increase age and size-appropriate treatment and reduce incidences of wrong dosage. Because of these laws, in the past five years alone at least 130 medications have been studied for use in children.
•                     The Pediatric Medical Device Safety and Improvement Reauthorization Act  (PMDSIA) of 2012 will support the continued development of medical devices intended specifically for children. The bipartisan legislation reauthorizes the original 2007 law co-authored by Reps. Markey and Rogers and includes a grant program to bring scientists and innovators together to hasten the development of pediatric devices. The bill also incentivizes the development of devices that serve children with rare conditions.