Transcript SPOOS” The Do’s and Don’t of “Significant Payments of

The Medical Device User Fee and
Modernization
Act of 2002 -- “MDUFMA”
Overview of Key Provisions
Michael A. Swit, Esq.
Law Offices of Michael A. Swit
[email protected]
FDACounsel.com
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Background
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Two bills in Congress – both
introduced by James Greenwood (R-Pa.)
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H.R. 3580 – “Medical Device Amendments
of 2001”
H.R. 5651 – “MDUFMA”
Signed by President on 10/26/02
Public Law 107-250
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User Fees
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Title I of MDUFMA = User Fees
Adds new §§ 737, 738, et seq., of
Federal Food, Drug, and Cosmetic Act
On or after 10/1/02, types of
submissions triggering full fees for the
submitter:
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
PMA
“Premarket Report” – i.e., a report
under 515(c)
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User Fees …
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Submissions Triggering Full User Fees:
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“Panel Track Supplement” – i.e., one that
requests:
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either:
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a significant change in design or performance of device,
or a new indication for use; and
for which clinical data are generally necessary to provide
a reasonable assurance of safety and effectiveness
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User Fees …

Submissions Triggering Full User
Fees:

“Efficacy Supplement”
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Definition: a supplement to an approved
premarket application under section 351 of the
Public Health Service Act that requires
substantive clinical data
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User Fees …
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“Partial Fees” – types of submissions:
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“180-day Supplement” –
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Definition -- § 738 – one that requests a significant
change in components, materials, design, specification,
software, color additives, or labeling
BUT
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Is not a panel-track supplement
Fee amount – 21.5% of fee for a full PMA – or $33,110
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User Fees …
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“Partial Fees” – types of submissions:
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“Real-Time Supplement”
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Definition – a supplement requesting a minor change to
the device such as to the design of the device, software,
manufacturing, sterilization or labeling
and
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Where applicant has requested – and FDA granted – a
meeting or similar forum to jointly review the status of
the supplement
Fee amount – 7.2% of PMA fee -- $11,088
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User Fees …
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510(k)s – 1.42% of PMA fee or
$2,186.80
Exempt Submissions – no fees!!
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“Humanitarian Use Devices” –
Biologic devices where the application
seeks to get a license providing “for
further manufacturing use only”
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User Fees …
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Exempt Submissions – no fees!! …
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Filings by state, local or federal
governmental bodies.
510(k)’s submitted for third-party review
pediatric use only filings – must be
“solely” for pediatric labeling
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later “adult” filings – must pay appropriate
fee
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User Fees …
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Logistics
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Payment -- due on submission (if you
filed between 10/1 and 10/26, you will be
billed
Amounts – set by HHS going forward,
except for FY 2003, where Congress set
the PMA user fees as $154,000
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User Fees …
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Logistics …
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Refunds –
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“refused for filing” – get back 75%
application withdrawn before “filing decision” – get back
75%
application withdrawn before first FDA action – FDA
“may return some or all of fee” based on “level of effort”
FDA already expended
must request within 180 days of original fee due date
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User Fees …
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Small businesses – may be entitled to a
waiver or reduction in fees
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definition -- < $30 MM in sales
amount of reduction –
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PMA -- 38% of normal fee (= $58,520)
510(k) – 80% of normal fee (= $1,749) – but, does not
apply in FY 2003
Note – FDA, in 11/21/02 FR notice, includes
affiliate sales in calculating $30 mm “small” cutoff
– is consistent with MDUFMA
Need to file certified tax returns to qualify
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User Fees …
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Targets for FY Gross Fee Revenues
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2003 -- $25,125,000
2004 -- $27,255,000
2005 -- $29,785,000
2006 -- $32,615,000
2007 -- $35,000,000
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User Fees …
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What if you don’t submit?
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Application will be considered incomplete
and shall not be accepted for filing
Other Requirements Under
MDUFMA
Title I:

§103 – Annual reports to Congress on FDA
progress toward meeting performance
goals in the “letters”
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User Fees …
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Other Title I Requirements …
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§104 – additional appropriations for post-market
surveillance –
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2003 – an increase of $3 MM
2004 – an increase of $6 MM
Study on various aspects of FDA’s ability to conduct
postmarket surveillance
Study Report – Due Jan. 10, 2007
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User Fees …
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Other Title I Requirements …
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§105 – “Consultation” – relative to reauthorization
after FY 2007, the Secretary is to consult with:
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House Energy & Commerce Cmte.
Senate Health, Ed., Labor & Pensions Cmte
“scientific and academic experts, health care
professionals, reps of patient and consumer advocacy
groups” and
regulated industry
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User Fees …
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Other Title I Requirements …
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§106 – Effective Date – 10-26-02, but applies to
filings made between 10-1 and 10-26
§107 – Sunset – midnight on September 30, 2007.
§738(g) – “Early Sunset” aka “Eclipse” provisions
– complicated formula; if FDA doesn’t meet goals,
early sunset after FY 2005
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User Fees …
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FDA Implementation – 11/21/02
Federal Register – 67 Fed. Reg. 70228
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lays out fees
FDA can’t collect until there are “enabling
appropriations”
Interim procedures:
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Title II – Selected Key Amendments
on Medical Devices
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§204 – “Combination Products” -- Amends
§503(g) of the Act to:
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Establish, at the Commissioner’s office level, an
office on Combination Products
Office duties:
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to promptly assign FDA “Center” with “primary
jurisdiction” to the product
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note: “primary jurisdiction” not changed
coordinate reviews among centers
ensure consistency among similar reviews
Annual report to Congress on implementation
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Title II – Amendments re Regulation
of Medical Devices …
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§205 – “Report on Certain Devices” –
by 10/26/03, Secretary to report to
Congress on “the timeliness and
effectiveness of device premarket
reviews by centers other than
[CDRH]…”
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detailed logs
recommendations on how to improve
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Title II – Amendments re Regulation
of Medical Devices …
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§209 – “Modular Review” – amends
§515(c) of Act to formalize the modular
review process.
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Note – is a permanent change to FFDCA;
however, is not applicable if fees are not
being collected due to either:
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Eclipse under §738(g); or
Full sunset after FY 2007 (i.e., no
reauthorization)
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Title II – Amendments re Regulation
of Medical Devices …
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§210 – Pediatric Expertise Regarding ClassificationPanel Review of Premarket Applications – amends
§515(c) of FFDCA to require that, “where
appropriate”, panels include or consult with “pediatric
experts.”
§212 – IOM Study on Postmarket Surveillance re
Pediatric Populations – study to see if system
“provides adequate safeguards” on device use in
pediatric populations.
 will include focus on implanted devices
 Congressional report of study due in 4 years
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Title II – Amendments re Regulation
of Medical Devices …
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§213 – Guidance on Pediatric Devices –
within 270 days of enactment, Secretary
“shall issue” guidance on:
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type of information necessary to provide
reasonable assurance of the safety and
effectiveness of medical devices intended for
pediatric use; and
protections of pediatric subjects in clinical
investigations of the safety or effectiveness of
such device.
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Questions?
Call, e-mail, fax or write:
Michael A. Swit, Esq.
Law Offices of Michael A. Swit
539 Samuel Ct., Suite 229
Encinitas, California 92024
760-815-4762 ♦ 760-454-2979 (fax)
[email protected]
http://www.fdacounsel.com
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About the speaker ...
Michael A. Swit has extensive experience in all aspects of FDA regulation with a particular emphasis on
drugs and medical device regulation. In addition to his regulatory law experience, Mr. Swit also
served for three and a half years as vice president and general counsel of Pharmaceutical Resources,
Inc. (PRI) a prominent generic drug company and, thus, brings an industry and commercial
perspective to his representation of FDA-regulated companies. While at PRI from 1990 to late
1993, Mr. Swit spearheaded the company’s defense of multiple grand jury investigations, other
federal and state proceedings, and securities litigation stemming from the acts of prior management.
Mr. Swit then served from 1994 to 1998 as CEO of Washington Business Information, Inc. (WBII) a
premier publisher of FDA regulatory newsletters and other specialty information products for the
FDA publishing company. Before starting FDACounsel.com, he was with Heller Ehrman from
May 2001 to May 2003, and also twice in private practice with McKenna & Cuneo, from 1988 to
1990 and, most recently, from 1999 to 2001, first in that firm’s D.C. office and most recently, in its
San Diego office. He first practiced FDA regulatory law with the D.C. office of Burditt & Radzius
from 1984 to 1988. Mr. Swit has taught and written on a wide variety of subjects relating to FDA
law including, since 1989, co-directing a three-day intensive course on the generic drug approval
process, serving on the Editorial Board of the Food & Drug Law Journal, and editing a guide to the
generic drug approval process, Getting Your Generic Drug Approved, published by WBII. Mr. Swit
holds an A.B., magna cum laude, with high honors in history, in 1979, from Bowdoin College, and
earned his law degree from Emory University in 1982. He is a member of the California, Virginia
and District of Columbia bars.
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