The U.S. House Energy & Commerce Committee staff have asked the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO) to offset some or all of the cost of the proposed 21st Century Cures Act, according to individuals involved in the discussions.
According to a report in BioCentury The trade associations adamantly refused to consider the proposal in a conversation with E&C staff this week.
A discussion draft of the legislation released last week included $10 billion over five years to create an “Innovation Fund” at NIH. The draft employed unusual language to bypass the standard funding process, avoiding the need for approval by House and Senate appropriations committees. E&C Chairman Rep. Fred Upton (R-Mich.) has said the bill will be fully paid for, which means the committee will have to find revenue or savings to cover its costs and make the bill budget-neutral.
Industry objects to paying for the 21st Century Cures Act because companies feel the current discussion draft contains few provisions that would benefit them. Provisions in the first discussion draft that would have provided generous additional market exclusivity for many drugs were stripped out due to objections from Democrats.
Per BioCentury, Biopharma companies are also disappointed by language in the draft on biomarker qualification, a top priority for industry, because it codifies current FDA practice and is unlikely to increase the number of qualified biomarkers. Companies also do not want to set a precedent for industry funding of NIH. Industry is already paying directly for numerous FDA programs through user fees, and will certainly be asked to increase its contributions to cover the cost of the Breakthrough Therapies program in PDUFA reauthorization negotiations.