Medical Bill Aims to Cure Diseases Nationwide (21st Century Cures Act)

[JPV]

Medical Bill Aims to Cure Diseases Nationwide

(WBNG Binghamton) A medical research bill, if signed by President Obama, will allow nearly $9 billion in extra funds to be used for biomedical research.

The bill is known as the 21st Century Cures Act, and it has been passed by the House of Representatives-- 344 to 77.

If made into a law later this year, funding for it will help find cures and speed the delivery of treatments for a variety of diseases.

Funding for the National Institutes of Health will increase by almost $9 billion over the next five years. Additionally, the FDA will receive an additional $550 million.

Rep. Chris Gibson (R) was a co-author on this bill, which includes provisions to combat Lyme disease.

If passed, Lyme disease-- and other tick borne illnesses-- will be top priority for research.

 

[Sasha]

This is great news - Brian Vastag (@viggster) said in his letter to NIH Director Collins in the Washington Post on Monday:

Earlier this year, the Institute of Medicine made a strong call for a robust ME research program. And just last month, an NIH-appointed panelurgently made the same recommendation. With the bipartisan 21st Century Cures Act poised to pass Congress -- giving NIH an extra $8.75 billion over five years -- you could do so without pulling money from existing programs.​

So it's just become political very easy for Dr Collins to act.

 

[Snow Leopard]

"If signed"... with baited breath.

 

[JPV]

The bill seems to have a lot of support from both parties.

I get the impression that a big component is some sort of deregulation of pharmaceuticals, which is kind of a double-edged-sword. We might get more drugs faster but they probably won't be as well tested...

Rep. McMorris Rodgers continues work on 21st Century Cures Act

U.S. Republican Rep. Cathy McMorris Rodgers of Washington State authored six major provisions in the 21st Century Cures Act, which the U.S. House of Representatives overwhelmingly approved this month by a bipartisan vote of 344-77.

Throughout the summer, McMorris Rodgers plans to keep forward motion progressing as part of a bipartisan coalition of supporters. The Congresswoman says the bill package helps modernize federal HIPAA [Health Insurance Portability and Accountability Act] laws, accelerates the discovery of new cures, creates research consortia to treat pediatric disorders, and brings the regulatory framework into the 21st Century by embracing technologies that focus on patient-specific therapies and the potential for powerful indicators, like Biomarkers.

“Innovation and discovery should be accelerated; treatments should be quickly available; and we should be curing diseases here in the United States,” the Congresswoman said. “This legislation helps achieve that.”

The 21st Century Cures Act, H.R. 6, was introduced May 19 by Rep. Fred Upton, R-Mich. On a fast track, the bill passed the House July 10. On the Senate side, the bill has been referred to the Senate Health, Education, Labor, and Pensions Committee.

 

[Nielk]

Has it already been decided which diseases will be covered? Can we still advocate for inclusion?

 

[Nielk]

Here is the summary of the bill:

21st Century Cures Act

This bill amends the Public Health Service Act to reauthorize the National Institutes of Health (NIH) through FY2018. The NIH Innovation Fund is established to fund a strategic plan, early stage investigators, and high-risk, high-reward research.

The NIH may require scientific data to be shared if the research is fully funded by the NIH.

The NIH and the Food and Drug Administration (FDA) must implement a system that allows further research on clinical trial data.

The Centers for Disease Control and Prevention must expand surveillance of neurological diseases.

The Council for 21st Century Cures is established to accelerate the discovery, development, and delivery of innovative cures, treatments, and preventive measures.

The Department of Health and Human Services must monitor the use of antibacterial and antifungal drugs and resistance to these drugs.

Requirements are established for interoperability and certification of health information technology. Practices that discourage the exchange of electronic health information are prohibited.

This bill amends the Federal Food, Drug, and Cosmetic Act to revise the drug approval process, including by: (1) allowing patient experience data to be considered in the risk-benefit assessment of a new drug, (2) requiring the FDA to qualify drug development tools, (3) allowing the FDA to rely upon data previously submitted for a different purpose to expedite the development of certain drugs, and (4) establishing a streamlined data review program for approval of a drug for an additional indication.

Manufacturers and distributors of investigational drugs for serious conditions must publish their policies on compassionate use requests.

The marketing exclusivity period is extended by six months for a drug approved for a new indication that is a rare disease or condition.

The priority review voucher program for rare pediatric diseases is revised and extended.

The FDA must: (1) establish a program for priority review of breakthrough medical devices, (2) identify types of devices that do not require a report preceding introduction, and (3) rely on a third-party to determine the safety and effectiveness of changes to medical devices.

Regarding medical devices, this bill defines “valid scientific evidence” and makes changes to classification panels and the humanitarian device exemption.

“Health software” is defined and, with certain exceptions, exempted from FDA regulations.

This bill amends title XVIII (Medicare) of the Social Security Act to require the Centers for Medicare & Medicaid Services (CMS) to: (1) increase certain payments for new antimicrobial drugs, (2) establish a payment methodology for certain medical devices, and (3) publish online estimated payments for certain outpatient items and services.

A pharmaceutical and technology ombudsman within the CMS must respond to complaints from manufacturers of medical products.

Medicare prescription drug plan sponsors may limit the access of certain beneficiaries to frequently abused drugs.

This bill amends the Controlled Substances Import and Export Act to allow exported controlled substances to be re-exported within the European Economic Area.

 

[duncan]

I'm pretty sure Lyme is in there. Lots of grass roots efforts from the Lyme community to ensure that it happens. I think it's passed the first hurdle.

 

[Violeta]

Those are both government agencies, if Obama doesn't sign it I will be very surprised.

 

[Nielk]

It passed in the House. Next is the Senate, then the President.