I wonder how many of you have ever heard of H.R. 6? It was passed on July 10th of this year. I didn't hear about it until I was speaking to Senator Pete Sessions in late September. I meant to research it then, but kept forgetting. I heard its name again this week. Because I am once again putting aside my public speaking fears and speaking in Fort Worth next week, I decided it was time to learn a little something about this act.
Purpose
The purpose of the 21st Century Cures Act is "expediting research and development on debilitating diseases, and making it easier to get important treatments to the patients who need them." (http://www.theatlantic.com/politics/archive/2015/07/21st-century-cures-act-bipartisan/398369/)
Major highlights of the Act include:
- increasing research collaborations (imagine! working together to find cures!!)
- promoting personalized drug treatments (think biomarkers, targeted therapies)
- streamlining clinical trials by making it easier for pharmaceutical companies to bring drugs to market (will this help reduce the exorbitant cost of drugs? Or, as critics warn, weaken the safety standards?)
- creating incentives for the development of treatments for uncommon but deadly diseases (this surely gets two thumbs up)
- encouraging young scientists to stay in the research field (huge!)
- providing more funding to National Institutes of Health (NIH) ($1.75 billion per year for the next five years) and the Food and Drug Administration (FDA) ($110 million per year)
Facts
Here are some facts, according to an article in The Atlantic and a FAQ from the Energy and Commerce Committee:
- Passed through House Energy and Commerce committee with a 51-0 vote (nearly unheard of in today's climate, especially for a bill that is termed "substantive and substantial")
- Funding will come, in part, from a modest reduction of the Strategic Petroleum Reserve (SPR)
- Bringing new drugs to the market can cost hundreds of millions of dollars (or more), meaning promising ideas are abandoned or tabled.
- For every 5,000 to 10,000 promising treatments, only one or two end up in the marketplace
- Finding a cure or effective treatments for the more than 5 million US citizens who suffer from Alzheimer's could cost the federal government $15 trillion over the next 40 years; currently the disease accounts for nearly $140 billion per year in Medicare and Medicaid payments.
- The FDA would be required to listen to patient voices/experiences when approving experimental drugs and devices
- Patient-generated registries would be used to recruit participants in clinical trials
- Genetic testing would determine a patient's predisposition to respond to targeted therapies
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