By Rachel Sachs
Earlier today, the House Energy and Commerce Committee released the most recent draft of the 21st Century Cures Act, in time for it to be marked up by the Health Subcommittee tomorrow. At 300 pages, the new draft adds back in a number of provisions that were excised from the previous, 200-page iteration of the draft. I haven’t had time to uncover all of the new additions just yet, but given that this is my third blog post on the subject, I wanted to highlight some of the ways in which this version differs (and doesn’t differ) from the last draft.
First, many parts of the draft have remained the same from the last version. The Medical Product Innovation Advisory Commission I had expressed excitement about in my first blog post about the Act remains absent. And today’s draft retains the last version’s addition to the NIH budget of an extra $2 billion each year for five years beginning in fiscal year 2016, which I blogged about last month.
Second, the new draft has added back in some of the exclusivity provisions that were excised from the previous version. The first of the exclusivity provisions provides for an additional six months of exclusivity for drugs which are approved for a new indication for a rare disease or condition (section 2151). The second is a reauthorization of an existing exclusivity system, the Priority Review Voucher for Rare Pediatric Diseases (section 2152), which previously contained a sunset provision of March 17, 2016. For those who are interested, Alexander Gaffney has a lengthy regulatory explainer of the FDA’s authority to issue Priority Review Vouchers for both pediatric diseases and neglected tropical diseases over at RAPS. But importantly, the new draft still does not contain the 15-year exclusivity period for “dormant therapies” present in the first draft of the Act.
Third and finally, the Act contains a section under the heading of “Encouraging the Development and Responsible Use of New Antimicrobial Drugs” (section 2123). This is not actually a new provision – it was in both of the previous drafts – but I’ve just now noticed it. It’s particularly interesting because the way in which the Act proposes to encourage the development of new drugs is to provide for higher Medicare payments for certain antimicrobial drugs. Kevin Outterson has previously addressed the question of insurance reimbursement for antibiotics, and I’ve just finished a draft of a paper on the broader potential of prescription drug reimbursement to serve as a prize-like innovation incentive, rather than simply as a mechanism for achieving access to medicines. This proposal employs a number of the strategies I lay out as possible advantages of reimbursement over other statutory or regulatory reforms, and I will be watching it closely as the draft moves forward.
This draft is changing and moving extremely quickly. I’ll be very interested to continue tracking its progress through the Committee!