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Senate Moves to Floor Phase for Innovation Bill .pdf



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Related Articles: 6

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Senate Moves To Floor Phase For
Innovation Bill; Postmarket
Surveillance, LDTs Could Get
Attention
By Sue Darcey / Email the Author
Regulatory & Policy News / Word Count: 1050 / Article # 01160411015 /
Posted: April 7 2016 4:25 PM

Executive Summary
The Senate HELP Committee passed more measures for its planned medical
innovation bill, including one affecting FDA's issuance of guidances versus
formal rulemaking, and another in support of the administration's Precision
Medicine initiative at an April 6 markup. Leadership also promised later floor
debate on laboratory-developed test regulations and a device postmarket
surveillance bill.

Lab Group Urges FDA To Wait
For Congress On LDT Issue
“The Gray Sheet” Apr. 7, 2016
Senate Bill Would Encourage
Adverse-Event Reporting
Experimentation
“The Gray Sheet” Mar. 22, 2016
Senate Panel Passes
Breakthrough Device, Other
Measures; FDA Funding Debated
“The Gray Sheet” Mar. 10, 2016
Commissioner Califf Touts Use
Of EHRs To Help End Clinical
Trial Disparities
“The Gray Sheet” Mar. 7, 2016
President Urges Breaking Down
Of Drug, Device Distinctions,
Regulatory Barriers
“The Gray Sheet” Feb. 25, 2016
Senate HELP Advances Device
Review Reform Bills
“The Gray Sheet” Feb. 9, 2016

Key Documents: 3
Click a document title to review.

A Senate committee approved a new round of medical innovation bills, including
one to help FDA and the National Institutes of Health to attract better medical
researchers and reviewers, and another supporting the Precision Medicine initiative,
during an April 6 markup. And during the Senate Health, Education, Labor, and
Pensions (HELP) Committee session, Chairman Lamar Alexander, R-Tenn.,
promised future floor debate "on the issue of lab-developed tests" and on
postmarket surveillance of devices, even though the committee has not addressed
those issues in its recent markups.
The chairman also said he was searching for an agreement with fellow senators on
funding for a "one-time funding surge" for NIH to help support all the medical
innovation priorities Congress approves. Ranking Member Sen. Patty Murray, DWash., and Sen. Elizabeth Warren, D-Mass., continued to insist that FDA also

RobertsS1onFDAguidances
FDA and NIH Workforce Authorities
Modernization Act
Precision Medicine_Managers

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needs additional funding to carry out additional responsibilities imposed by bills
under consideration.
The April 6 session was the committee's final markup of bills destined to be rolled
up into a larger innovation bill following sessions in February and March. Legislation
that passed through the committee during the earlier sessions included several
intended to smooth the path to market for devices and diagnostics, such as the
Device Accountability Act and a breakthrough device bill, as well as one piece of
device safety legislation that seeks to clarify when new 510(k) submissions are
needed for design changes. (See "Senate HELP Advances Device Review Reform
Bills" — "The Gray Sheet," Feb. 9, 2016.)

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Subjects
Legislation
Regulatory
Industries
Medical Devices
In Vitro Diagnostics
Molecular Diagnostics
Laboratory Testing Services

Other device reform bills approved by Senate HELP during a March 9 session
included a combination products bill and the digital-health focused MEDTECH Act.
(See "Senate Panel Passes Breakthrough Device, Other Measures; FDA Funding
Debated" — "The Gray Sheet," Mar. 10, 2016.)

Amendment Would Force Legal Justification For FDA
Guidance
The HELP panel also agreed to an amendment
that would call on FDA to
provide a legal explanation as to their use of a guidance, rather than formal
rulemaking, each time the agency drafts a new guidance. The amendment was
attached to S. 2700, the FDA and NIH Workforce Authorities Modernization Act,
before it was passed by the HELP panel on a voice vote.
"Guidance documents are increasingly used to affect policy changes, imposing new
requirements on those regulated by the agency even though these documents are
not legally binding. My amendment is simple – It asks the FDA to show its work,"
Roberts explained.
However, ranking member Murray said that FDA Commissioner Robert Califf would
oppose such a provision because it would slow down guidance work at the agency
by "throwing sand in the gears."

More Device-Related Bills Could Be Added On Senate
Floor
A second amendment to S. 2700, sponsored by Sens. Pat Roberts, R-Kan, and
Amy Klobuchar, D-Minn., that would "increase transparency on review of medical
devices" was ultimately withdrawn. Roberts said he would work with Alexander and
Murray on the language, which would ease FDA acceptance of device consensus
standards and calls for pilot projects on new modes of adverse-event reporting, with
the goal of bringing it up on the Senate floor later. (See "Senate Bill Would
Encourage Adverse-Event Reporting Experimentation" — "The Gray Sheet," Mar.
22, 2016.)
Chairman Alexander appeared to run out of time to reach committee consensus on
S. 2737 and two other amendments that would impact the device and diagnostics
industry – one on medical device postmarket surveillance and another related to
oversight of lab-developed tests. (See "Lab Group Urges FDA To Wait For
Congress On LDT Issue" — "The Gray Sheet," Apr. 7, 2016.)

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Page 3 of 4

He said, "I would like to take the proposals we've passed here today, along with a
bipartisan agreement on the NIH innovation fund with Senator Murray, and put them
in Senator McConnell's [the Senate Majority Leader] hands as the Senate's
contribution to a 21st Century Cures Act." He added, "We'll have an opportunity for
more debate on the floor," including on additional bills to address:
• Improving postmarket monitoring of medical devices, a priority of Murray
and a "top priority" for FDA Commissioner Dr. Robert Califf, Alexander said;
• The regulation of lab-developed tests; and
• A proposal by Sens. Mark Kirk, R-Ill., Joe Manchin, D-W.Va., and Susan
Collins, R-Maine, to create a first-time conditional approval for regenerative
medicine treatments.

FDA and NIH Workforce Act
As approved by Senate HELP, the FDA and NIH Workforce Authorities
Modernization Act, S. 2700
, would permit the two agencies to recruit a cadre of
biomedical research experts – not to exceed 2,000 – to conduct clinical research
evaluations or biomedical product assessments, and could be compensated at
higher pay levels compared to existing scientists, physicians and engineers at FDA
and NIH.
Those eligible for the "expert" designation would have to have obtained doctoral- or
master's-level degrees in engineering, bioinformatics, or a related or emerging field,
the proposed legislation says.
The bill would help FDA and NIH "attract and retain the talent they need to handle
all the exciting developments headed their way for research and review," Alexander
said.

Advancing Precision Medicine
The Advancing Precision Medicine Act
(S. 2713) would establish the necessary
authorities to carry out President Obama's Precision Medicine Initiative. (See
"President Urges Breaking Down Of Drug, Device Distinctions, Regulatory Barriers"
— "The Gray Sheet," Feb. 25, 2016.) Specifically, the bill is focused on:
• Developing a network of scientists to help carry out the initiative;
• Developing new approaches for addressing scientific, medical, public health
and regulatory science issues;
• Applying genomic technologies to provide data on the molecular basis of
disease; and
• Collecting information voluntarily provided by a diverse cohort of individuals
that can be used to better understand health and disease.
The bill would allow HHS, NIH, FDA and the Office of the National Coordinator for
Health Information Technology to coordinate with the Energy Department, private
industry and others to identify and advance any advanced supercomputing needs
for the initiative, and would protect the private health records of individuals who
contribute genomic information to the effort.
The committee also approved on April 6 a bill to shorten the development time for
antibiotics to treat "superbugs" that have become resistant to most antibiotic drugs;
a measure by Alexander and Murray to cut down on NIH researchers' paperwork;

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and a bill sponsored by Sens. Collins, Kirk, Murray and Alexander, and Sen.
Tammy Baldwin, D-Wisc., calling on NIH to include more women and minorities in
clinical trials and research. (See "Commissioner Califf Touts Use Of EHRs To Help
End Clinical Trial Disparities" — "The Gray Sheet," Mar. 7, 2016.)
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