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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
© 2015 Foley Hoag LLP. All Rights Reserved. 3
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.”
© 2015 Foley Hoag LLP. All Rights Reserved. 4
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)
© 2015 Foley Hoag LLP. All Rights Reserved. 5
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)]
© 2015 Foley Hoag LLP. All Rights Reserved. 6
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”
© 2015 Foley Hoag LLP. All Rights Reserved. 7
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)
© 2015 Foley Hoag LLP. All Rights Reserved. 8
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)
© 2015 Foley Hoag LLP. All Rights Reserved. 9
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)
© 2015 Foley Hoag LLP. All Rights Reserved. 10
Title III – Delivery
[Interoperability (§3001)]
Telemedicine (§3021)
[Disposable Medical Technologies (§3061)]
Improvements to Local Coverage
Determinations (§3081)
Medicare Site-of-Service Transparency
(§3131)
© 2015 Foley Hoag LLP. All Rights Reserved. 11
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."
© 2015 Foley Hoag LLP. All Rights Reserved. 12
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
© 2015 Foley Hoag LLP. All Rights Reserved. 13Proposal or event name (optional)
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Subtitle or Company Name
Month Day, Year
Thank you
Paul Kim
202.261.7360