Gottheimer Amendment to H.R. 3 Passes House, Protecting R&D for Rare and Life-threatening Diseases, Boosting North Jersey Life Sciences Innovation

Dec 12, 2019
Press

Gottheimer H.R. 3 amendment will support high-reward drugs -- Ensures we never give up hope that the next cure is within reach

Today, Thursday, December 12, 2019, U.S. Congressman Josh Gottheimer’s amendment to H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act, passed the U.S. House of Representatives. Gottheimer’s amendment requires the Department of Health and Human Services (HHS) to identify conditions without an FDA-approved treatment where the development of a treatment would fill an unmet medical need for a serious or life-threatening condition or rare disease. The amendment also requires HHS to identify appropriate incentives that would lead to the development of such treatments.

Today, Gottheimer spoke on the House floor in support of his amendment.

“My amendment will ensure continued innovation and research to further the development of life-saving medicines for rare diseases, including cancers, Alzheimer’s, ALS, and rare disorders. The Congressional Budget Office and other studies have shown potential reductions in the number of drug approvals each year as a potential risk of H.R. 3. This amendment helps address that concern,” said Congressman Josh Gottheimer (NJ-5) on the House floor today. “Targeted therapies and medicines serving smaller populations stand to lose the most from this blow to R&D. These are areas where the science is the most difficult, but also the most important, such as cancers and other rare diseases. In the greatest country in the world, where we innovate like no one else, it’s critical we never give up hope that the next cure is within reach. My amendment today will help us reach that goal of curing our most life-threatening diseases.”

Gottheimer has noted that his amendment to H.R. 3 is vital due to the bill’s potential impact on research and development efforts for early-stage drug applications that could provide cures for critical conditions such as cancer, Alzheimer’s disease, ALS, and rare disorders.

In New Jersey alone, the biopharmaceutical industry supports more than 300,000 jobs and $83 billion in economic output every year. There are approximately 139 manufacturing plants in New Jersey that are involved in the production of medicines for patient use.

Watch Gottheimer’s remarks on the House floor HERE.

Gottheimer’s remarks as prepared for delivery are below.

I rise today in support of my amendment to H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act of 2019.

My amendment will ensure continued innovation and research to further the development of life-saving medicines for rare diseases, including cancers, Alzheimer’s, ALS, and rare disorders.

The challenge now is that at best only one out of every twenty clinical trials results in a cure. This of course means that manufacturers invest billions before they find a medicine that can go to market to help save lives. They don’t just bet on the winners, they have to also bet and take a lot of risks that don’t turn out to succeed and get to market. America has the best medical innovators in the world. When our health is on the line, we can’t stop taking those risks to make sure that we find those cures. We can’t risk falling behind.

My amendment provides investment in qualified clinical testing for drug applications that address unmet medical needs to treat rare and life-threatening diseases — diseases that may go unaddressed without extra incentives.

The amendment requires HHS to conduct a study to identify diseases without an FDA-approved treatment and where the development of a treatment would fill an unmet medical need for serious or life-threatening conditions or rare diseases.

The amendment also requires HHS to identify appropriate incentives that would ensure the continued investment in the development of these treatments — treatments that will save lives. of children and adults, of seniors, of our families.

The Congressional Budget Office and other studies have shown potential reductions in the number of drug approvals each year as a potential risk of H.R. 3. 

This amendment helps address that concern.

Targeted therapies and medicines serving smaller populations stand to lose the most from this blow to R&D. These are areas where the science is the most difficult, but also the most important, such as cancers and other rare diseases.

Cures for these conditions could always be just around the corner, but not if we are forced to abandon what might be the next cure.

While I appreciate the intention of H.R. 3 to re-invest savings in medical research, including at NIH and the FDA, without this amendment there would still no clear answer to explain what might happen to the incredible research and development work that occurs every day in the private sector. This amendment addresses that.

I know how critical NIH funding is and have consistently advocated for increasing the investment in research there. However, NIH does not manufacture medication. And neither does the FDA. The private sector, including all the research being done every day in my home state of New Jersey, manufacture the life-saving medications that Americans rely on every single day.

It’s also why my colleague, Republican Fred Upton, and I – Fred from Michigan – we introduced bipartisan legislation this week, the Protecting America’s Life Saving Medicines Act, to ensure that life sciences companies continue to invest in these innovative drugs, with a tax credit for qualified clinical research. Again, to ensure that this research keeps getting done, that they keep making the bets on moon-shot drugs, that, without those investments, might not save lives like they do today.

Again, in the greatest country in the world, where we innovate like no one else, it’s critical we never give up hope that the next cure is within reach. My amendment today will help us reach that goal of curing our most life-threatening diseases.

Thank you, Mr. Chairman, and I reserve the balance of my time.

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