Markey-Authored Provisions in FDA Safety and Innovation Act Will Support Advances in Pediatric Drugs and Devices, Rare Diseases Research, Drug Labeling for Blind

WASHINGTON, D.C. – Congressman Edward J. Markey (D-Mass.), senior member of the Energy and Commerce Committee, which has jurisdiction over the Food and Drug Administration (FDA), spoke on the House floor today in support of S. 3187, the FDA Safety and Innovation Act, which passed the House of Representatives this afternoon. The legislative package contains several Rep. Markey-authored provisions that help FDA continue its mission of bringing safe and effective drugs and medical devices to the patients who need them.  
This legislation does an excellent job of supporting FDA’s key missions, and I strongly support its passage,” said Rep. Markey. “I’m pleased that this bill includes language I helped author to improve collaboration between FDA and external experts in rare diseases like Cystic Fibrosis. The legislation also includes an important provision to ensure that the millions Americans who are blind or visually-impaired have safe and independent access to the information on prescription drug labels. Additionally, the bill helps increase the availability of pediatric medical devices and ensure that medications are tested and labeled appropriately for children. I would have liked to see additional measures included in the bill to address the safety of medical devices based on defective models that FDA is unfortunately required to clear, and I will continue to work on this critical issue.”
The FDA Safety and Innovation Act package includes the following provisions authored by Rep. Markey:

  • 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 Mike Rogers (R-Mich.) 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.
  • The Prescription Drug Labeling Promotion Act of 2012 will help ensure that the blind and visually impaired have safe and independent access to the information on prescription drug labels. This provision establishes a working group of pharmacists, patient advocates, and federal regulators who would issue best practices for pharmacies to ensure that people who are blind or visually-impaired have access to prescription drug labeling. The working group will examine what options are feasible for pharmacies of different sizes, such as small rural pharmacies. GAO will analyze the degree to which pharmacists are adhering to the guidelines and whether there continues to be a lack of access to prescription drug labeling for the blind and visually-impaired.