We are grateful to Representative Matsui for asking a question on the BENEFIT Act during today’s House Energy and Commerce Committee hearing entitled “The Future of Medicine: Legislation to Encourage Innovation and Improve Oversight.”

This hearing reviewed over 20 different bills intended to improve drug development processes, including HR 4472 the BENEFIT Act. Congresswoman Matsui used her time to ask witness, Cartier Esham, Ph.D. Chief Scientific Officer, Biotechnology Innovation Organization (BIO), about the importance of incorporating patient experience data into drug reviews and whether it would be helpful to know more about whether and how the patient experience data submitted to FDA was useful.

Dr. Esham commented that BIO is in support of the legislative concept and looks forward to working with the committee on such language. We thank BIO for their support and leadership in Patient Focused Drug Development.

A Recording of Today’s Remarks

About the BENEFIT Act

The BENEFIT Act would require FDA to include in the risk-benefit assessment framework of a new drug application clarity around how patient experience data was considered in the review process.

What happens next?

The path of legislation through Congress into law can be long and complex, but the holding of a congressional hearing by the House Energy and Commerce Committee is a critical first step in its consideration.

Next steps can include the bill being “marked up” and voted on by the Energy and Commerce Committee before consideration on the House floor, as well as potential parallel consideration in a hearing and markups by the Senate Health, Education, Labor, and Pensions (HELP) Committee.

There are two likely legislative vehicles by which the BENEFIT Act could possibly be passed into law this year:

• It could be included in the Prescription Drug User Fee Act (PDUFA) authorization currently moving through Congress. Today’s hearing was held to look at bills like the BENEFIT Act related to FDA that could potentially be included PDUFA. This is considered “must pass legislation” by Sept 30th of this year.
• It could be passed into law as stand-alone legislation. The BENEFIT Act passed the Senate on its own in 2017, but did not advance further at the time.

Regardless of the path by which the bill might follow and where it is in the process, support from more Members of Congress can always help! Please reach out to your members of Congress and ask them to cosponsor the BENEFIT Act.

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We will keep the community updated on progress with the BENEFIT Act.