Bipartisan Action on Medical Innovation Is Within Reach: It’s Time to Help Millions of Americans Find Cures

By Janet M. Marchibroda, Ashley Ridlon

Tuesday, September 6, 2016

As Congress returns from recess, it’s time to turn attention to bipartisan action that will accelerate the delivery of life-saving, safe, and effective cures for patients.

Emerging therapies offer the promise of cures for those with Alzheimer’s, cancer, Parkinson’s, and other life-threatening diseases. Yet on average, it takes $2 billion and a decade for new drugs and other therapies to get to market.

Thankfully, over the last several months, the Senate Health, Education, Labor, and Pensions (HELP) Committee and the House of Representatives took action on legislation to advance medical innovation in the United States. The legislation includes support for the White House Precision Medicine Initiative as well as the Cancer Moonshot, which is releasing a report today.

Emerging therapies offer the promise of cures for those with Alzheimer’s, cancer, Parkinson’s, and other life-threatening diseases. 

In July 2015, the Bipartisan Policy Center released 19 recommendations for improving the medical development process, increasing regulatory clarity, strengthening the ability for the Food and Drug Administration (FDA) to carry out its mission, and increasing investment in medical products to address unmet and public health needs. A majority of these recommendations were reflected in the Senate HELP Committee package or the House 21st Century Cures Act, including those related to increasing the generation and use of real world evidence to improve medical product development and approval processes, integrating patient perspectives into the drug development process, advancing precision medicine, improving the review of combination products, enhancing the FDA’s ability to hire and retain staff, increasing regulatory clarity associated with health information technology, and improving the interoperability and sharing of electronic health records.

BPC was also pleased to see so many of its recommendations, including those related to real world evidence, patient input, and FDA hiring and retention practices in the draft commitment letter for the Prescription Drug User Fee Act (PDUFA) VI reauthorization.

It’s time to take the steps needed to accelerate the discovery, development, and delivery of safe and effective cures for patients.

The opportunity to take bipartisan action that will support millions of Americans is within reach. It’s time to take the steps needed to accelerate the discovery, development, and delivery of safe and effective cures for patients.

View a comparison of BPC recommendations to the Senate HELP Committee package, the House 21st Century Cures Act, and the PDUFA VI draft commitment letter.

KEYWORDS: 114TH CONGRESS, 21ST CENTURY CURES, FOOD AND DRUG ADMINISTRATION, SENATE HELP COMMITTEE