21st century cures - massmedic...title ii –breakthrough devices priority review for breakthrough...

21st Century CuresWhat's in it for MedTech?

Paul Kim

Partner, Foley Hoag

MassMEDIC Webinar

Monday, May 11 2015

© 2015 Foley Hoag LLP. All Rights Reserved. 2

Agenda

What is “21st Century Cures”?

Overview of Cures by Title

Key Provisions

Next Steps


What is 21st Century Cures?

In 2014, House Energy & Commerce

Committee Chairman Fred Upton (R-MI)

partnering with Diana DeGette (D-CO)

“[F]or the first time ever, we in Congress are going to

take a comprehensive look at what steps we can take

to accelerate the pace of cures in America. We are

looking at the full arc of this process – from the

discovery of clues in basic science, to streamlining the

drug and device development process, to unleashing

the power of digital medicine and social media at the

treatment delivery phase.”


Title I - Discovery

Authorizes NIH funding at $31.8B in FY2016 and

$34.85B in FY2018. In contrast, FY2015 NIH

appropriations of $30.3B and FY2016 Administration

request of $31.3B (§1001)

Creates NIH Innovation Fund – $2B per year from

FY2016-2020 for precision medicine, young emerging

scientists (§1002) – a National Pediatric Research

Network, ‘other transactions’ authority (§1026), and

allows NCATS to support Phase II/III trials

NIH ‘may’ require data sharing from NIH-supported

research (§1101)

Clinicaltrials.gov standardized search criteria (§1102)


Title II – Discovery (Rx)

Bayesian and adaptive trials (§2061), “utilize

clinical experience”/Sentinel (§2062), data

summaries to support supplemental NDAs

(§2063)

Expanded access ‘mandate’ (subtitle E)

Clarify dissemination of healthcare economic

information to P&Ts, payers (§2101)

[“Repurposing drugs for serious and life-

threatening diseases and conditions” (subtitle I)]


Title II – Breakthrough Devices

Priority Review for Breakthrough Medical

Devices (§2181)

- To provide FDA with “sufficient authorities to apply

efficient and flexible approaches to expedite the

development of, and prioritize the agency’s review of,

devices that represent breakthrough technologies.”

- Team supervised by senior personnel to “facilitate

efficient development review”, “provide for interactive

communication”, “expedite review of QSR

compliance”, advance disclosure of AdCom topics

- Early “binding agreement on protocols, but “nothing…

to alter [PMA and 510(k)] criteria and standards”


Title II – Device Improvements

[Third-Party Quality System Assessment

(§2201)]

Valid Scientific Evidence (§2202)

- “May include” registry data, studies published

in peer-review journals, and data collected in

countries other than US

Training And Oversight In Least-Burdensome

Means Concept (§2203)


Title II – Device Improvements

Recognition Of Standards (§2204)

[Notification Of Marketing Of Certain Class I

Devices (§2205)]

Advisory Committee Process (§2206)

Humanitarian Device Exemption Application

(§2207)

CLIA Waiver Study Design Guidance For In Vitro

Diagnostics (§2208)


Title II – Software and Clinical Trials

Software (subtitle M)

- Final regulations for “health software”

Streamlining Clinical Trials (subtitle N)

- Use of non-local IRBs for IDEs and HDEs

(§2242),

‘FDA Collaboration’ (subtitle O)

- Silvio Conte research opportunities (§2261), Reagan-

Udall Foundation (§2263)


Title III – Delivery

[Interoperability (§3001)]

Telemedicine (§3021)

[Disposable Medical Technologies (§3061)]

Improvements to Local Coverage

Determinations (§3081)

Medicare Site-of-Service Transparency

(§3131)


Criticisms

Public Citizen: “providing perks to the pharmaceutical

and medical device industries to approve medications

and devices faster based on weaker evidence.”

National Center for Health Research: [Breakthrough

devices] would be dangerous to patients... [Our research

finds] that companies making risky implanted devices

currently provide very little scientific research backing up

the 510(k) clearance process… The last thing patients

and doctors need is an even skimpier process."


Next Steps

Upton wants to enact legislation this year

DeGette says subcommittee and full committee mark-

ups scheduled soon to maintain momentum

FDA, other agencies giving technical assistance; final

Administration position?

Senate bipartisan hearings, discussions on their

parallel effort underway; Alexander-Burr white paper

2016 Presidential election will effectively shorten

legislative calendar next year

Over the horizon: Omnibus User Fee reauthorization

‘must pass’ in CY2017

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Thank you

Paul Kim

[email protected]

202.261.7360

mailto:[email protected]

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