The House Energy and Commerce Committee http://energycommerce.house.gov has discussed the 21st Century Cures Initiative with providers, consumers, patients, regulators, and experts. Many of the discussions and hearings have centered on precision medicine so the right patient can receive the right treatment at the right time.
The “21st Century Cures Act” has been under development since 2014, and recently on April 29th, the bipartisan Energy and Commerce Committee released an updated draft of a piece of the legislation. One of the main goals in the new updated draft is to see FDA www.fda.gov approve new medicines at a faster pace to treat medical conditions that presently lack cures
Some of the other goals in the draft include working in the telehealth space, moving forward on an interoperable healthcare system, streamlining, standardizing, modernizing clinical trials, incorporating innovative statistical methods in clinical protocols, plus effectively examining products used outside of clinical trials.
To move the legislative process forward, the House Energy and Commerce Subcommittee on Health held a hearing to discuss the draft legislation. FDA’s Dr. Janet Woodcock, Director, of the Center for Drug Evaluation and Research, and Dr. Jeff Shuren, Director of the Centers for Devices and Radiological Health both report they are pleased that provisions are included to help incorporate patients and their ideas in the decision-making process as regards to the benefits and risks of new products.
On May 6th, the Alliance for Health Reform www.allhealth.org held a briefing at the National Press Club with Dr. Andrew von Eschenbach former Commissioner of the FDA to discuss in- depth the new draft legislation pertaining to the “21st Century Cures Initiative”.
As a former Director of the National Cancer Institute www.cancer.gov, Dr. Eschenbach thinks that the legislation when passed has the potential to be one of the most transformational pieces of legislation that has come along since the National Cancer Act of 1971.
The new draft bill contains a section requesting a definition of a precision drug since that was not in the original draft. The bill directs FDA to provide guidance on the definition of a precision drug targeted to treat patients with a specific genotype of a disease. The guidance would also help sponsors develop these drugs.
The draft bill seeks funding to increase for NIH www.nih.gov and to establish the NIH Innovation Fund with $2,000,000 in funds each year from 2016 through 2010. The funding would help support precision medicine and be used to attract young emerging scientists.
The draft does address some provisions on coverage although it does not cover access to high cost medications. However, the draft does contain greater clarity on coverage as it pertains to CMS www.cms.gov. Two of the provisions would provide for reimbursement for certain telehealth services and create care coordination networks to help children with complex medical conditions.
The Energy and Commerce Committee view the draft as an initial step that will probably change over the next weeks ahead. However, the thinking is that the House will be aggressive in moving the bill forward.