On June 8, 2017, the Energy and Commerce Committee voted unanimously to approve an amended version of HR 2430, the FDA Reauthorization Act (FDARA) of 2017. The bill would extend the FDA prescription drug, medical device, generic drug, and biosimilar biological product user fee programs, which are scheduled to expire at the end of September. The bill also includes a variety of policy revisions, including provisions intended to improve the medical device inspection process and to establish a voluntary medical device safety/surveillance pilot project, and a “sense of Congress” resolution that the HHS Secretary and Congress should take steps to lower the cost of prescription drugs.
The Committee also voted to approve HR 1222, the Congenital Heart Futures Reauthorization Act; HR 2410, the Sickle Cell Disease Research, Surveillance, Prevention and Treatment Act; and HR 1492, the Medical Controlled Substances Transportation Act (to update the Drug Enforcement Administration registration process for mobile medical practitioners).