Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) delivered the following opening remarks at a full Committee markup of six health bills today:
Today, the Committee convenes to mark up six bipartisan health bills, including legislation to reauthorize and improve programs at the Food and Drug Administration (FDA), address the mental health and substance use disorder crises, and establish President Biden’s ARPA-H initiative.
We will begin today by taking up the Food and Drug Amendments of 2022, comprehensive bipartisan legislation to reauthorize FDA’s user fee programs and improve FDA’s review of drugs, biologics, and medical devices.
The bill will also reduce drug costs, improve program integrity and oversight in the accelerated approval program, and improve diverse representation in clinical studies.
With the ongoing infant formula shortage, I am pleased the amendment in the nature of a substitute will extend an authority first provided in the 21st Century Cures Act that will allow FDA to retain top scientists and high-level professionals not just for its drug, biologic, and medical device centers, but also the Center for Food Safety and Applied Nutrition, and other product areas regulated by the agency.
While we certainly have more work to do in this area, including this provision today will improve the agency’s oversight of these products—including infant formula—and help avoid tragedies that led to the death of two infants due to contaminated formula.
This bill has been crafted with consensus in mind from the start, as it is critical we pass this on time, before FDA funding runs out.
Next, we’ll turn to the consideration of the Restoring Hope for Mental Health and Well-Being Act, which I introduced with Ranking Member Rodgers. This is a comprehensive bipartisan package that includes provisions from members of the Committee on both sides of the aisle. It reauthorizes more than 30 programs that aim to help Americans in need—providing access to critical mental health and substance use disorder support and care.
We will consider two amendments to the mental health package that represent months of bipartisan negotiation on two important bills, the MAT Act and the MATE Act.
Together, these policies will increase access to medication-assisted treatment for opioid use disorder and substance use disorder treatment, as well as help address some of the stigma associated with addiction. I am glad that we were able to work together between our Subcommittee markup and today’s markup on these two amendments, and I’m hopeful they will be included in our mental health package as it advances out of Committee.
We will also consider another amendment that will help strengthen mental health parity by providing funding to states to implement and enforce parity. This is critical in eliminating disparities in insurance coverage and treatment.
The committee will also vote on three bipartisan bills and the bipartisan Advanced Research Project Agency-Health Act, or “ARPA-H,” led by Chairwoman Eshoo. This legislation will create an independent ARPA-H that accelerates biomedical innovation and makes transformative breakthroughs in the most challenging diseases.
I look forward to advancing all six of the bipartisan bills before us today, and I thank Ranking Member Rodgers for her shared commitment to making this bipartisan markup possible.
Go to Source