Key FDA Legislation Passes Energy & Commerce Committee
WASHINGTON, DC – Today, the House Energy & Commerce Committee held a markup session to examine a package of user fee agreements to reauthorize key FDA capabilities to review and evaluate medical devices, brand and generic drugs, and biosimilar products. During the markup, the committee also passed 11 energy infrastructure bills, and three health bills that will address congenital heart diseases, sickle cell disease research, and controlled substances.
“It is critical that these programs be reauthorized in a timely manner. Failure to do so would derail clinical trials, grind research to a halt, and put the new therapy pipeline in jeopardy. We have had hearings on the underlining agreements and the feedback was overwhelming positive. Much progress has been made since the first user fee agreement was made in 1992 and I’m pleased we are advancing these reauthorizations,” said Green.
Health legislation that passed the committee and will be sent to the House floor includes:
H.R. 2430, FDA Reauthorization Act of 2017
- FDARA is a package of the Food and Drug Administration (FDA) user fee agreements regarding prescription drugs, medical devices, generic drugs, and biosimilars.
H.R. 1222, Congenital Heart Future Reauthorization Act of 2017
- H.R. 1222 builds on existing efforts by requiring CDC to enhance and expand its research, surveillance infrastructure, and public outreach and education programs relating to congenital heart disease.
H.R. 2410, Sickle Cell Disease Research, Surveillance, Prevention and Treatment Act of 2017
- The bill would reauthorize the Sickle Cell Disease Treatment Demonstration Program and allow up to 25 eligible entities to receive grants under the program. H.R. 2410 also would allow the Secretary of Health and Human Services to conduct or support research to help increase understanding of sickle cell disease
H.R. 1492, The Medical Controlled Substances Transportation Act of 2017
- This legislation would allow a physician registered with the Drug Enforcement Administration (DEA) to transport controlled substances to another practice for the purpose of administering the substances.
Copies of the legislation can be viewed HERE.