Food and Drug Administration Safety and Innovation Act

Floor Speech

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Mr. WARNER. Mr. President, I rise today to add my voice to the bipartisan support for the Food and Drug Administration Safety and Innovation Act, S. 3187.

In addition to continuing the fee-based funding system for timely FDA reviews, S. 3187 also calls for strengthening early scientific dialogue and transparency, promotion of innovation through enhanced communications, and modernization of regulatory science.

These provisions, including enhancing dialog between the FDA and medical device, pharmaceutical, generic and biotechnology companies early in their new product development cycle, will facilitate a clearer understanding of the specific criteria the FDA will require in its review process and provide a succinct roadmap for successful product approval.

The ultimate goal is to reduce misunderstandings and expensive superfluous testing, with the hope of reducing the time and costs to bring new medical technologies safely to patients in need.

I want to commend the chairman of the HELP committee, my friend Senator Harkin, and the ranking member, Senator Enzi, who worked to find bipartisan consensus on these provisions.

By creating a more user friendly and accessible FDA, innovative U.S. companies built on the principle of American ingenuity, will be attracted and encouraged to develop new medical devices, technologies and pharmaceuticals.

With this new cooperation, together we will extend the quality of life for our citizens, reduce healthcare complexities and costs, create new U.S.-based jobs, and move this current national crisis to a financially manageable level for individuals, employers and tax payers.

For example, in my State of Virginia, medical and bioscience research and development is vibrant in our academic institutions and among our companies, both large and small. The biopharmaceutical companies employ nearly 77,000 workers in Virginia, both directly and indirectly. In the bioscience field alone employment has grown by 23 percent, compared to 6 percent total growth statewide and 3.5 percent across all sectors in the U.S.

We have a number of companies rushing to develop and market new products and technologies that are focused on improving healthcare delivery at a lower cost premium--companies like Engineered BioPharmaceuticals in Danville, VA, who is focused on repositioning current and future pharmaceutical therapeutics to be more effective at lower doses, with longer shelf-lives and better consumer compliance.

To help these companies, and encourage more innovation, I am glad to see that the FDA has committed to being more open with applicants about using more appropriate data, but also communicating why certain data is not able to be used. I look forward to working with stakeholders and the FDA in monitoring this issue.

One of the most exciting innovations in health care is related to mobile and health IT markets. Estimates indicate that the number of smartphone consumers using medical apps will grow to 500 million by 2015.

How these innovations are regulated matters a great deal. It is important to balance market creativity, with patient safety issues and the intended use of the medical software.

A number of agencies have jurisdiction over pieces of mobile medical applications, including FDA, Office of National Coordinator, ONC, and the Federal Communications Commission, FCC,--to properly regulate health information technology as well as address proper regulations of mobile medical applications.

I am pleased that language has been included in this bill which asks for the Secretary to work across the different agencies--the FDA, ONC, and FCC--to come up with guidance that makes sense. It also encourages an outside stakeholder group to be consulted.

I would like to thank my colleagues Senator Bennet, Senator Burr, Hatch and Coburn for their leadership on this as well.

I would also like to briefly acknowledge language in the FDA bill regarding the use of data from clinical trials conducted outside the United States. As many in industry will tell you, there are a number of countries around the world that have comparable safety standards as the U.S.

I have been interested in learning more about the application of appropriate clinical data across borders. I believe that if the FDA can do more to establish comparability between its guidelines for clinical trials and those set by countries in the European Union, for instance, we may be able to reduce the need for duplicative work and we may be able to get safe products to market sooner.

The FDA has committed to being more open with applicants about using this type of data. They have agreed to provide applicants with more information about why certain data is not appropriate for use in the U.S. The FDA will also report on regulatory science, which will specifically indicate which specific metrics can be used to determine comparability.

I am hopeful that there will soon be measurable improvement on this issue, and I look forward to working with interested stakeholders and the FDA to do more in this area in the future.

One final point I would like to make is about something that is not directly included in this bill, a new innovation--biomarkers.

Preeclampsia is a disorder that affects hundreds of thousands of pregnant women every year which undiagnosed can put a woman at risk for death and the fetus at risk of still-birth.

Doctors currently use a mix of imprecise signs and symptoms to diagnose it but oftentimes such signs and symptoms are wrong. However, researchers have found a biomarker--a particular biological process or sign--that can accurately identify women with preeclampsia that are at risk for pregnancy complications.

Unfortunately, tests for novel biomarkers are taking 5 or more years to get approved by the FDA, delaying patients from receiving the benefits of more accurate diagnoses and treatments.

I was pleased that a recent commitment letter between FDA and industry specifically mentions the FDA's commitment to work together with industry to create a transitional IVD, or ``T IVD'' process for the development of tests for novel biomarkers.

I look forward to seeing how this T IVD process develops in discussions between FDA and industry and am interested in progress towards its implementation which supports advances in the sciences and promotes access to these emerging diagnostics.

If reducing healthcare costs is a national priority, we need to act today. I encourage my colleagues to pass S. 3187 and allow the FDA to work more closely with the medical industry to safely bring new technologies to the marketplace.

Let's increase the quality of life of our citizens, structurally reduce healthcare costs without increasing risks to patients and stimulate the growth of American ingenuity and U.S.-based jobs.

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