Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) delivered the following remarks on the House floor today on reauthorizing the Food and Drug Administration user fee programs included in the continuing resolution:
In June, House Democrats and Republicans came together to pass, by an overwhelming supermajority, a sweeping package of reforms at the Food and Drug Administration. That bipartisan legislation would strengthen the integrity of the Accelerated Approval program, foster innovation, improve clinical trial diversity, and reauthorize the agency’s medical product user fee programs. Those user fee programs help fund FDA reviews for safety and efficacy of drugs and medical devices.
While the House completed its work in June, the Senate failed to act.
As soon as we passed our legislation through the House, I reached out to Ranking Member Rodgers and the Democratic and Republican leaders of the Senate HELP Committee to begin bipartisan, bicameral conversations to come to an agreement on a package of mutually agreeable FDA reforms. After weeks of negotiation, our talks hit a temporary roadblock with Senator Burr, the Republican Ranking Member of the Senate HELP Committee. But we stayed at the table, and eventually the negotiations were fruitful. We were able to come together to find common ground across several meaningful policy areas.
Unfortunately, despite this progress, Senate Minority Leader McConnell decided to stand in the way of enacting bipartisan policies to improve public health. Senator McConnell threatened to hold up government funding if our FDA reforms were included in the continuing resolution we are debating today.
While I am pleased that we are reauthorizing user fees, which will prevent layoffs at the agency and allow FDA to continue its mission, I will continue pushing for the widely supported improvements at the agency.
I have secured commitments from Senators Murray and Burr, as well as Ranking Member Rodgers, to continue working to finalize a package of FDA reforms before this continuing resolution expires in December, and I look forward to taking meaningful action in the near future. For now, I encourage members to support continuing the work at FDA by voting in favor of the continuing resolution.
And with that I yield back the balance of my time.
Original source can be found here.
