Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) delivered the following remarks as prepared for delivery today on the House floor during consideration of H.R. 7667, the Food and Drug Amendments of 2022:
I rise today in strong support of the Food and Drug Amendments of 2022, a bill that recently passed out of the Energy and Commerce Committee with unanimous support. This bill will provide the Food and Drug Administration (FDA) the funding it needs to ensure drugs and devices are safe and effective. It also promotes development of new medical products to treat every American, reduces the cost of prescription drugs, and strengthens program integrity at the agency.
Primarily, the user fee reauthorizations’ main purpose is to give the agency funding to conduct product reviews, facilitate the development of new products to treat rare diseases, inspect facilities to ensure they are compliant, and monitor medical products on the market for continued safety and effectiveness.
It is essential that the House pass this legislation today because funding that comes from these user fees expires in September. At hearings earlier this year, senior FDA officials told us that failure to pass this legislation well before the September deadline could be catastrophic to the agency’s operations, and more importantly, could limit our ability to get patients the medical products they and their doctors rely on.
I am very pleased that in addition to coming together to reauthorize this funding, we have worked across the aisle to come to agreement on a wide-ranging package of programs to improve biomedical research and development, give FDA more tools to conduct quality inspections, improve the medical product supply chain, improve generic drug competition and access, and bring greater transparency and program integrity to FDA’s operations.
While I do not have time to discuss all the provisions in FDA22, I want to highlight a few. First, the bill includes reforms to the accelerated approval program, which I first introduced in Congress earlier this year. Under the accelerated approval pathway, drugs may be approved based on a surrogate endpoint, such as an improved lab measurement or visualization on an MRI, even though additional evidence is still needed to show a clear clinical benefit for patients. If a drug is approved under this pathway, the sponsor must conduct studies after the product is on the market to show that the drug actually provides a benefit to patients. This approval pathway has led to patients having access to groundbreaking treatments for cancer, HIV, and other illnesses faster than they otherwise would have.
However, in recent years, it has become clear that some drug sponsors have failed to conduct their post-approval studies in a timely manner, while others have conducted studies that indicate that the drug is not effective but are able to keep the product on the market for years afterward.
Patients deserve to know the drugs they are taking are safe and effective. FDA22 ensures that the products patients are taking are providing a benefit by allowing FDA to require that sponsors begin adequate and well controlled post-approval studies before the drug goes on the market. The legislation will provide greater transparency in drug labeling. And it streamlines the process for FDA to remove products from the market when the sponsors have failed to act with due diligence to conduct studies, or where studies have failed to show a benefit to patients.
Second, this legislation ensures that clinical trials for drugs and medical devices are representative of the people who will use the products. The lack of diversity in clinical trials is an urgent problem. It compromises our ability to understand how drugs and diseases affect populations differently, compounds health disparities, and can also hinder innovation and add cost burdens onto the health system.
FDA22, for the first time, will require drug and device sponsors to develop a clinical trial diversity action plan early in the development process, and submit the plan to FDA. This will help improve our understanding of these products and lead to better outcomes for all Americans.
FDA22 will also help lower drug costs by making it easier for generic drugs to come to market. Under current law, generic drug sponsors sometimes need to play a guessing game of the ingredients in brand drugs. This can add months onto the generic drug development process. Under FDA22, we are making it easier for FDA to communicate this information to drug sponsors, thereby speeding up development time for generics. The bill will also make it easier for generics to come to market when a brand drug changes its label at the last second in an attempt to limit competition. Together, these provisions will produce millions of dollars in savings for American families and the overall health care system.
This legislation also takes concrete action to address the infant formula crisis American families are currently facing and will prevent future problems related to food safety and supply.
Currently, FDA is operating its food safety and other divisions with one hand tied behind its back when it comes to hiring and retaining highly qualified scientific and regulatory staff. Today, FDA can hire technical staff in its drug and medical device centers under streamlined processes and compete with the private sector in terms of salary, but those same flexibilities do not extend to other centers, including those overseeing food, at FDA. Our bill would extend these to the oversight of food, tobacco, and other products regulated by the agency. While we must do more in this area, I am pleased that we are able to move forward on a bipartisan basis here today.
Mr. Speaker, I want to thank my colleagues on the Energy and Commerce Committee for their cooperation and bipartisan work on this package. As I said, it passed unanimously out of the Committee last month thanks to the leadership of Health Subcommittee Chairwoman Eshoo, Ranking Member Guthrie, and full Committee Ranking Member Rodgers. I encourage all members to support this legislation, and I reserve the balance of my time.
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