Food and Drug Amendments of 2022

Floor Speech

Mr. Speaker, I rise today in support of the Food and Drug Amendments of 2022, introduced by Chair Eshoo and myself. This legislation recently passed the full Energy and Commerce Committee unanimously.

The bill will protect access to lifesaving cures, promote innovation, secure our medical supply chains, and lower costs for patients. It would also reauthorize the Food and Drug Administration's medical product user fee programs through 2027.

User fees allow the FDA to collect fees from industry in exchange for timely review of their drug or device applications. Importantly, these fees not only permit the FDA to carry out drug or device application reviews, but they also represent significant percentages of FDA's total operating budget without costing the taxpayer.

Additionally, according to the Congressional Budget Office, sections of the bill will save close to $600 million by promoting increased access to generic drugs. Some of these savings will be used for deficit reduction and other amounts can be put toward preserving access to critical services in the Medicaid program, such as telehealth.

Not only do these agreements help save taxpayer dollars, but they also yield significant returns on investment since they were originally authorized by Congress decades ago. For example, in 2021 alone, 38 of 50 of the world's novel drugs were first approved in the United States. This was made possible by the Food and Drug Administration Amendments of 2017.

I am proud to say that the legislation includes two of my bills, the Pre-approval Information Exchange Act, which will help reduce the time in which patients wait for a drug or a device to be covered by the insurer after it is approved by the FDA.

The bill before us today also includes legislation that Chair Pallone and I have been championing for several years to help facilitate the transformation of drug manufacturing processes, so they are more efficient, less costly, and result in improved drug quality. The use of continuous manufacturing technology will not only serve as an incentive for U.S. drug manufacturers to bring their production back to American soil but will also help reduce drug shortages.

Other important components of the Food and Drug Amendments of 2022 require guidance on the collection of real-world evidence for companies with products authorized under emergency use authorization during the COVID-19 public health emergency. This can serve as a strong foundation for the regulatory community in addition to drug or device companies to best understand how products can get approved more quickly and safely in the future.

Finally, the Food and Drug Amendments of 2022 preserves access to lifesaving therapies approved under the accelerated approval pathway. By preserving the pathway, we are giving patients hope to one day find cures to currently incurable diseases, such as Alzheimer's disease or terminal cancers.

As the Chair said, usually when you come to the floor on suspension bills, they are ones that have great unanimous consent with Congress. This has gone through the regular process, and it has gone through a lot of hard work by Members, but I have to say a lot of hard work, significant hard work, by the men and women who work with us here on the committee. We really appreciate the staff's hard work.

Although we are here in a suspension moment on the floor, I emphasize to my colleagues, there has been a lot of work, a lot of committee work, a lot of subcommittee work, a lot of Member work, and a whole lot of staff work to make this move forward. I really appreciate that.
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Mr. GUTHRIE. Mr. Speaker, I was incorrect. I said Mr. Bucshon. Dr. Bucshon; his words on healthcare are certainly very important to all of us.

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Mr. GUTHRIE. Madam Speaker, I yield myself such time as I may consume.

Madam Speaker, through the years, since this medical device fee has been put into place, has Congress taken action to make sure an agency is efficient; that it does its job to make sure that our drugs and medical devices have efficacy, but also are safe? So we make them more efficient and we have drug companies, device companies, other companies, generic companies, trying to get their devices or their pharmaceuticals approved so they can bring them on the marketplace that are safe and efficient. So this is really an example of Congress working together to move this process forward.

And the innovations that have come out in the last few years, if we look at what has gone on in the diabetes world with the artificial pancreas, all the pumps and insulin devices, to hepatitis C, pharmaceuticals and other ways, and just so much more, what is going to happen in the next 5 years as we continue to move this process forward?

We had a hearing in the Subcommittee on Health on ALS, and we had an ALS patient before us who just wants hope. So all of that is accounted for in this process.

We, as Members of Congress, we, as members of the Committee on Energy and Commerce have worked together to make the process streamlined, to make sure we have efficient, efficacy, and safe products. Our hope and our prayers from this is the science will come into place so those who testified before our committee with rare diseases will have the opportunity and hope to be healed.

I urge my colleagues to support this piece of legislation. A lot of hard work went into it. A lot of lives can be affected by it. I encourage everyone to vote for it.

Madam Speaker, I yield back the balance of my time.

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