New Discussion Draft of 21st Century Cures Act Released (Again)

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!

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This entry was posted in FDA, Health Law Policy, Medicare/Medicaid, Pharmaceuticals, Rachel Sachs, Research Funding by rachelsachs. Bookmark the permalink.

About rachelsachs

Rachel Sachs is an Associate Professor at the Washington University in St. Louis School of Law. Previously, she was an Academic Fellow at the Petrie-Flom Center. Rachel earned her J.D. in 2013 magna cum laude from Harvard Law School, where she was the Articles Chair of the Harvard Law Review and a student fellow with both the Petrie-Flom Center and the John M. Olin Center for Law, Economics, and Business. Rachel has also earned a Master of Public Health from the Harvard School of Public Health, during which she interned at the United States Department of Health and Human Services. Rachel's primary research interests lie at the intersection of patent law and health law, with a particular focus on problems of innovation and access and the ways in which law helps or hinders these problems.

3 thoughts on “New Discussion Draft of 21st Century Cures Act Released (Again)

  1. Sorry, I am not impressed with this.This “bill, act, beaurocratic bullshit” slaps the face of Dr. Bruzinski of Texas. I am not sheeple; I became logical long before I entered school earning myself only a certificate and forward of that – professionally certified. The old boys and girls on the hill depress medical progresses by allowing the FDA and related entities to denounce, secretly threaten and completely dismiss sensibility and research pertaining to serious disease processes of the human. So they passed an Act. The operative word here is act, whether capitilized or not. Washington doesn’t Act or act for the good of civilization. Furthermore – why does paperwork have to be passed to ALLOW for medical related research to secure viability (or ultimately – the existance of) the human race?

  2. Not sorry to inform, but this is obvious beaurocratic bullshit. Why does an “act” have to “pass” to progress medical studies of disease processes that threaten human life? Again – not sorry to inform: tell/share this waste of paper, valuable time on the hill (pondering significance of said “act”) to Dr. Bruzinski of Texas (unless he and his family are in hiding from the US Government and no longer existing in Texas). This act likely serves only to ultimately proport and/or channel monies. From a quite simplistic point of view – securing the viability of the human race is understood by unprovoked individuals such as (Dr. Bruzinski). But the US economic interests is more pressing than cures for horrible human disease. Additionally – sheeple are not aware their government suppresses and threatens honorable and learned peoples (because they are misinformed or not informed at all) (per government control put upon news media) about such serious matters. This beurocratic bullshit wastes the time of humanity. One must always keep in mind that in Amerika – one can go to prison for securing cannibus (illegally of course) to afford some definition of comfort to an individual suffering of a disease process their own government purposely diverted recognition of and support of, a sound or logical pathway possibly resulting a cure of. In Amerika – human suffering is big bucks baby. I firmly believe a cure or near cure of (example – cancer) could be achieved or substationally progressed, but, those on the hill need human time to write into, and/or economically budget balance (one of only two) economic engine drivers left in this country i.e. medicine and insurance.ured a way to write into or balance the economic benefit/interest of)

  3. I will summarize my opinion. This is another (do not pardon my french) – I’ll repeat – another bullshit bill, act, or law passing or trying to pass by the boys and girls on the hill. Think about it – why does or would humanity (regulate so to speak) progress to cure or substantially lessen discomforts born of human disease? Economics? Case and point: Dr. Bruzinski and his forward motion and thinking regarding a cancer cure. Amerikan economics would plummet so bad, hard and fast – the global community would be aghast.
    If not for medicine and insurance – what economic engines are left in Amerika? Explain my point of view or better – represent Dr. Brunzinski in a court of law regarding his interests.

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