Posted on December 19th, 2016
by Jeffrey Bacha
Last week, President Obama signed the 21st Century Cures Act into law. The Cures Act, which charged through the House and Senate fueled by significant bi-partisan support, may very well be the last law enacted by the President during his term in office.
The $6.3 billion Cures Act contains $4.8 billion in spending over 10 years for new research at the National Institutes of Health, including $1.8 billion for the cancer research “moonshot” championed by Vice President Joe Biden.
The Cures Act also contains significant elements that are geared to accelerating how drugs and medical devices are reviewed and authorized by the FDA. Ultimately, this will result in new life-saving and life-improving therapies.
The American Society for Clinical Oncology (ASCO) recognized this in its official statement noting, “This landmark legislation will spur development and delivery of promising new treatments for patients.”
The Cures Act will make it easier for drug companies to win approval for new indications of previously approved drugs, directing the FDA to develop policies to allow for expanded approvals based on “real-world” patient outcomes (rather than rigorous clinical trials). This concept seems in line with comments made by Jim O’Neill, one of president-elect Trump’s candidates to head the FDA.
The Cures Act also takes a big step toward making drugs being developed for “serious diseases” available to patients under expanded access or compassionate use programs. Drug companies must, within 60 days of the law’s enactment, post on their website their policies for making investigational drugs available to patients who are not in their clinical trials.
Another major impact of the Cures Act is the extension of the FDA’s pediatric priority review voucher program until September 30, 2020. Under the law, a developer of a treatment for a neglected or rare pediatric disease will receive a voucher for priority review from the FDA to be used with a product of its choice or sold to another developer. Priority Review Vouchers have significant market value: In August 2015, United Therapeutics sold its PRV to Abbvie for $350 million.
Critics of the new law, including Senator Bernie Sanders, expressed disappointment that the Cures Act does not take steps to curb drug pricing. That issue undoubtedly will remain in the forefront, but for now, we can revel in the fact that in a time of significant political divide our elected representatives came together in overwhelming bipartisan fashion to support new initiatives for better treatments and ultimately, we can hope, cures.
Forward Looking Statements
Any statements contained in this blog that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company's products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in our filings with the SEC, including, our current reports on Form 8-K.
This Blog is official and sanctioned by DelMar Pharmaceuticals, Inc.