By Reps. Fred Upton (R-MI), Joe Pitts (R-PA) and Michael C. Burgess, M.D. (R-TX) Chairman, Committee on Energy and Commerce; Chairman and Vice Chairman, Subcommittee on Health
For decades, the United States has led the global medical device and biopharmaceutical industries. With the U.S. serving as the life sciences innovation capital of the world, patients have gained access to life-saving devices and drugs while our economy has reaped the benefit of hundreds of thousands of high-paying jobs.
Our life sciences sector – from basic research to widely used treatments – is an American success story. Yet it is a story that is not complete. Experts agree we have merely scratched the surface of the medical breakthroughs that could come in the future. The question is, will the United States continue to be home to the latest innovations?
The life sciences sector is at a crossroads. Bureaucratic rules have caused the sector to grow sluggish. We are falling behind our global competitors. Some estimates show that medical devices may be approved almost four years earlier in Europe than in the U.S. This has led American patients and their doctors to travel overseas to access the newest innovations, and the U.S. device jobs have followed.
Congress took bipartisan action last year to break down barriers to health innovation, and the Food and Drug Administration will see changes as a result. It was an important first step, but challenges remain. For the good of patients, and to retain our global leadership and the economic benefits that come with it, it’s time to breathe new life into the life sciences sector.
Following are a series of policy concepts designed to restore and retain America’s leadership position in the life sciences. We look forward to discussing these concepts at the Health Subcommittee during the 113th Congress.
Solutions for Patients: Clearing the Path to New Treatments and Cures
1. Protect health-related “apps” from medical device taxes and bureaucratic red tape.
Innovation in mobile medical applications, wireless health technology, and health information technology can improve patient care, lower healthcare costs, and create American jobs. However, FDA has recently taken steps to regulate this area, which could significantly harm innovation. In addition, the Patient Protection and Affordable Care Act (PPACA) established a new tax on medical devices, and the administration has not been clear about whether it intends to impose this new tax on medical apps, wireless technologies, and other innovative products. The result is a cloud of uncertainty hanging over a sector that holds great promise for patients and our economy. To clear up the uncertainty, we will ensure Obamacare taxes and onerous pre-market approval requirements are not imposed on these innovative tools. Instead, we will pursue a health system that can quickly embrace technological advancements, making the most of rapidly developing tools while protecting patient safety.
2. Empower the sickest patients to pursue new treatments.
Innovative new drugs and therapies are constantly being developed to combat debilitating and deadly illnesses. However, it takes time to bring these treatments to market – sometimes years, as drugs undergo rigorous testing and review to ensure patient safety when in widespread use. Yet for some of our nation’s sickest patients, they cannot wait for years to learn about potential treatments. To empower the sickest patients to pursue available treatments, we will take steps to improve patient education and doctor communication about potential treatments.
3. Incentivize development of new antibiotics to address emerging threats.
It can take years of research and cost billions of dollars to develop a single new drug. Add to that the regulatory risk that comes from unpredictability at the FDA and a limitation on opportunities to recoup research investments, and it becomes clear that drug innovators are being pushed away from developing treatments that patients desperately need, including in the antibiotic space. While the GAIN Act was a great first step, we will pursue additional ways to foster investment in antibiotics. We will encourage FDA to collaborate with innovators to use improved and transparent standards for approval to make sure that safe and effective drugs for the 21st century get to patients in a timely fashion. Further, incentives should be applied across technologies so that we do not unintentionally discourage life-saving treatments from getting into patient hands.
4. Create an FDA Board of Directors and make “innovation” part of the agency’s mission.
Patients and innovators are on the front lines in the fight against diseases like Alzheimer’s and cancer, yet their voices are not always heard by FDA. There are two ways Congress can address this problem. First, we need to create an “FDA Board of Directors” comprised of patients. innovators and scientific experts that will evaluate FDA performance and make recommendations on how FDA can improve its performance. This will help in providing the oversight necessary to further correct FDA’s current problems. Second, we will embed innovation in FDA’s statutory mission statement. In 2012, the President’s Council of Advisors on Science and Technology recommended including “encouraging innovation” as part of the FDA’s mission statement in order to ensure that FDA understood its role in helping new innovative treatments reach patients.
5. Strengthen the security of our nation’s drug supply chain.
As drugs are manufactured and shipped across the country, patients want to know that the product they will eventually use is safe. At the same time, a fragmented or overly burdensome regulatory system for monitoring the drug supply chain could drive up costs and put treatments out of reach. To protect patient safety and access, and to provide clarity to drug makers, distributors and pharmacies, we will create a single, streamlined framework for drug supply chain tracking.