House Energy and Commerce Committee releases white paper on 21st Century Cures initiative
WASHINGTON — The House Energy and Commerce Committee on Tuesday released a discussion document in the 21st Century Cures initiative, outlining many of the ideas submitted over the past year, including ideas from both Republicans and Democrats.
This release marks the beginning of the #Cures2015 legislative phase. In conjunction with the discussion document, the committee is releasing a new white paper, continuing its request for feedback on the ideas outlined in the discussion document to accelerate the discovery, development and delivery of new cures and treatments.
The Generic Pharmaceutical Association expressed "disappointment" with the discussion draft. “GPhA is deeply disappointed in today’s 21st Century Cures discussion draft. While we appreciate that it is a draft, in its current form, the bill would upset the important balance between creating competition and encouraging innovation in the pharmaceutical marketplace, putting savings at risk and limiting access to affordable medicines for millions of American patients," stated Ralph Neas, GPhA president and CEO. "[T]he Dormant Therapies provision of the bill would potentially grant brand drug companies an unprecedented increase in exclusivity for a curiously broad category of new drugs, delaying the competition from generic drugs and biosimilars that promotes beneficial innovations in treatments."
According to Francis Collins, director of the National Institutes of Health, it now takes “around 14 years and $2 billion or more” to develop a new drug and “more than 95% of [such] drugs fail during development.”
The committee is circulating this discussion document with the intent of continuing the national dialogue. "While the legislative language released today is neither perfect nor complete, with the aforementioned goals in mind the committee has included provisions that would: (1) incorporate patient perspectives into the regulatory process and help address their unmet medical needs; (2) build the foundation for 21st century medicine; (3) streamline clinical trials; (4) support continued innovation at our federal public health agencies; and (5) modernize medical product regulation. The discussion is ongoing, and continued feedback in this collaborative effort is critical," the white paper stated.
"We appreciate the opportunity to review the discussion draft released today and look forward to providing feedback to the House Energy and Commerce Committee," commented John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America. “PhRMA supports the Committee’s goal of accelerating the discovery, development and delivery of new medicines for patients.”
In April 2014, Energy and Commerce Committee Chairman Fred Upton, R-Mich., partnered with Rep. Diana DeGette, D-Colo., to conduct a comprehensive look at the cycle of cures — from discovery to development to delivery and back to discovery.