Senate HELP Committee to mark up 21st Century Cures legislation
- The Senate Health, Education, Labor & Pensions (HELP) Committee will hold a mark-up of seven bills Wednesday morning as part of its effort to build counterpart legislation to the House's 21st Century Cures Act.
- Normally more bipartisan, the committee's members have been split on NIH and FDA funding, as well as on Republican efforts to expedite the FDA approval process. The bills on the slate for tomorrow will also touch on drug pricing and post-marketing surveillance.
- Democrats have proposed $5 billion in new funding for the NIH and FDA and want to limit the prices of several classes of drugs. On the other hand, Republicans are focused on streamlining the regulatory approval path, which Democrats feel goes to far in compromising FDA oversight.
While the House passed its 21st Century Cures Act, there has been notable division among members of the Senate on the best path forward for its version.
The Democrats would like to increase funding for the NIH and the FDA by $5 billion each year for 10 years through a special fund. This would support Vice President Joe Biden's Cancer MoonShot 2020 Initiative and the Precision Medicine Initiative. Republicans also support funding these initiatives, but at a lower level.
Chairman Lamar Alexander (R-TN) is focused on speeding up the FDA approval process for drugs and medical devices, according to the Wall Street Journal.
One interesting bill on the agenda for tomorrow would add Zika to the list of diseases eligible to receive a priority review voucher. This could further incentivize companies to devote more resources to developing a Zika vaccine. Upwards of 15 companies are currently involved in some time of work on a vaccine, although Sanofi, the NIH, and India-based Bharat Biotech appear to be the farthest along.
However, the priority review voucher system has come under criticism for rewarding companies who merely pushed a drug across the regulatory finish line, rather than developing a new product.
The next mark-up is on April 6, so the HELP Committee does have more time to work through partisan conflicts. But the process could be messy.
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