Looking at the Horizon:
Current & Future Regulatory Issues for the
Medical Device, Drug and Food Industries
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Our Team
Washington, DC
Chicago
Research Triangle Park
Portland
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The HHS and FDA Leadership Team
Under the Obama Administration
Gary L. Yingling
Partner
Washington, DC
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Secretary of the U.S. Dept. of Health and Human
Services - Kathleen Sebelius
Confirmed by Senate (65-31) and Sworn In by President on April 28th
Background:
Governor, Kansas ( 02 April 09)
State Insurance Commissioner ( 94 02)
State Legislator ( 87 94)
Dir. of Kansas Trial Lawyers Association ( 78
86)
Priorities (based on comments made during Confirmation hearings):
Health care reform
Food Safety Working Group Will co-chair group and advise President on methods for
examining and upgrading food safety laws, and enforcing existing and new laws
Creating a pathway for the approving of follow-on biologics
Increase foreign drug inspections
Improving FDA s regulation of medical product promotion
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Deputy Secretary of HHS
Bill Corr
Confirmed by Senate (unanimous consent) on May 6th
Background:
Executive Director, Campaign for Tobacco-Free Kids (anti-tobacco organization
that advocates FDA regulation of tobacco) ( 00 May 09)
Chief Counsel and Policy Director, Senator Daschle ( 98 00)
Deputy Assistant Secretary, HHS ( 93 to 96); Chief of Staff, HHS ( 96 - 98)
Staffer, Senator Metzenbaum ( 88 93)
Staffer, Representatives Rogers and Waxman ( 77 88)
Worked to limit the exclusivity provisions of the Orphan Drug Act
Priorities:
Will focus on health care reform
During confirmation, assured members of his recusal from tobacco-related
issues under the Obama Administration s ethics guidelines
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FDA Commissioner - Dr. Margaret Peggy Hamburg
Confirmed by Senate (voice vote) on May 18th
Background:
Physician (Internal Medicine)
Sr. Scientist, Nuclear Threat Initiative's Biological Programs ( 01
Assistant Secretary for Policy and Evaluation, HHS ( 97
May 09)
01)
Health Commissioner, New York City ( 91 - 97)
Assistant Director, The National Institute of Allergy and Infectious Diseases,
AIDS Research ( 89 - 90)
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Dr. Hamburg
Priorities (outlined during confirmation hearings):
Review FDA s work on the H1N1 influenza outbreak to evaluate the agency s
preparation and response.
Improve food safety by shifting to a prevention-first policy, focusing on import
safety and working more closely with our international allies.
Encourage advances in product safety by building safety considerations into
every aspect of product development, with close postmarket monitoring.
Foster industrial innovation, striving to appropriately balance this with regulation.
Assure accountability (FDA s work must be driven by the best possible science
and is undertaken with integrity, openness and credibility ).
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FDA Principal Deputy Commissioner - Dr. Joshua
Josh Sharfstein
Appointed on March 14th / Joined agency March 30th
Confirmation not required.
Background:
Pediatrician
Baltimore Health Commissioner ( 05 March 09)
Petitioned FDA to ban some pediatric OTC cough / cold meds.
Health Policy Advisor and Staffer, Rep. Henry Waxman and House Government
Reform and Oversight Committee ( 01 05)
Advocate for putting the tobacco industry under the regulation of the FDA.
Priorities:
Drug Safety
Food Safety (Orchestrated FDA s efforts with pistachio recalls)
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Senior Counsel to Deputy Commissioner - David
Dorsey, Esq.
Appointed by Sharfstein on 4/14/09.
Will oversee Office of Legislatives Affairs.
Will help develop agency policy and liaise with Congress.
Background:
Staffer, Sen. Kennedy (01/01
04/09)
Served as Senior Fellow on the Senate Health, Education, Labor, and
Pensions Committee
Worked on various pieces of legislation.
Associate Chief Counsel, FDA
Focused on medical devices, labeling and dietary supplements.
Has been on detail from FDA to Kennedy s staff.
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Deputy Commissioner for Scientific and Medical
Programs Jesse Goodman
Appointed by Sharfstein on 4/13/09.
Background:
Physician
Center Director, CBER ( 03- April 09)
Deputy Director, CBER ( 01- 03)
Sr. Advisor to FDA Commissioner Henney (1998)
Professor of Medicine and Chief of Infectious Diseases, University of Minnesota
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Acting Chief Counsel - Michael Landa, Esq.
Appointed by Sharfstein on 4/10/09.
Background
Regulatory Affairs Deputy Director, CFSAN (8/04
4/09)
Deputy Chief Counsel, FDA (1/00 - 7/04)
Acting Chief Counsel, FDA (3/01 - 8/01)
Partner, Heller Ehrman White & McAuliffe ( 93
99).
Associate, FDA s Chief Counsel Office (various periods between 78
93)
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Medical Devices:
Recent Developments and Regulatory Challenges
Suzan Onel
Partner
Washington, DC
Center for Devices and Radiological Health (CDRH)
2008-2009 Operative Words:
Upheaval
Under Siege
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Snapshot
Recent GAO Reports Related to Medical Devices
Status of 510(k) Review Program and Current Controversies
Financial Conflicts of Interest- Federal and State Activity
Federal Preemption
Pending Legislation
CDRH Enforcement Trends
Review Time Trends
Other Notable Developments
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2009 GAO Reports
Medical Devices: FDA Should Take Steps to Ensure that High-Risk
Device Types Are Approved Through the Most Stringent Premarket
Review Process
GAO Adds FDA Oversight of Medical Products to its 2009 High
Risk List
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510(k) Review Program
Review Process
Slower decisions and more questions
Brain drain
Fewer experienced reviewers- 70% new hires since 2005
Shuffling of reviewers within CDRH Divisions
Increased emphasis on clinical trials
Increased complexity of devices
Increased scrutiny of science and predicates
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510(k) Review Program
CDRH whistleblower letters to Hill and Administration question the
scientific basis for clearance decisions and integrity of review
process and leadership
Increased scrutiny of applications
Less open to creative predicates
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510(k) Review Program- Current Controversies
25 Class III Pre-Amendment Devices- Call for Data
Deadline: August 7, 2009
Currently allowed on market with 510(k); potential reclassification to
Class II or III
Modification Decisions
Edwards Lifescience Myxo ETlogix 5100 treatment for degenerative
mitral valve
Choices of Predicates
Vaginal Sling
Ophthalmic Lasers
Potential Rescission of 510(k)s
ReGen Biologics Menaflex Meniscus Collagen Scaffold for knee repair
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Conflicts of Interest Recent Federal and State Activity
Current FDA Disclosure Requirements
Voluntary Codes of Ethics
IOM Report
Recommends Congress create a national program requiring device
makers and foundations to report payments to healthcare providers
Recent NJ Attorney General Activity
Synthes - settlement
Stryker - ongoing investigation
Proposed Federal Legislation
State Activity: Massachusetts, Vermont; pending legislation in
Texas and Oregon
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Federal Preemption Potentially Challenged?
Medical Device Amendments of 1976
Express preemption recognized for PMA devices, not 510(k)
devices
Riegel v. Medtronic, Inc. (2008)
Increasing interest in reversing precedent by legislation
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Legislation Affecting Medical Devices
The Physician Payment Sunshine Act of 2009, S. 301
The Medical Device Safety Act of 2009, H.R. 1346 and S. 540
The National Pain Care Policy Act of 2009, H.R. 756 and S. 660
The Patient Access to Critical Lab Tests Act, H.R. 1699
The Protection for Participants in Research Act of 2009, H.R. 1715
The FDA Globalization Act of 2009, H.R. 759
The National Nanotechnology Initiative Amendments of 2009, H.R.
554
The Patent Reform Act of 2009, S. 515 and H.R. 1260
The National Neurotechnology Initiative Act, S. 589, H.R. 1483
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CDRH Enforcement Trends
Fiscal 2008
No seizures
No injunctions
No civil money penalty cases
134 warning letters
2472 recalls
Fiscal 2007
4 seizures
4 injunctions
1 civil money penalty case
155 warning letters
1279 recalls
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FDA Decisions and Average Review Time Trends
510(k)
FY 2008:
FY 2007:
FY 2006:
FY 2005:
Data not available
3168 decisions; review time unavailable
3447 decisions; 95 days (54 FDA days)
3344 decisions; 87 days (54 FDA days)
PMA
FY 2008:
FY 2007:
FY 2006:
FY 2005:
Data not available
35 decisions; review time unavailable
50 decisions; 335 days (283 FDA days)
51 decisions; 438 days (366 FDA days)
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Other Notable Developments
CDRH to move to White Oak Campus by July 31
Address, Phone, and Fax will change
ClinicalTrials.gov- registration of applicable device clinical trials as
of September 2008
Certification form (FDA-3674) must accompany FDA
submissions that include clinical trials
Penalties for failure to register
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Any questions or comments?
Suzan Onel, Partner (DC)
(202) 778-9134 (ph)
(202) 778-9100 (fax)
suzan.onel@klgates.com
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Short Break
Next Presentation:
Looking Backward & Looking Ahead: NDAs, ANDAs, DESI Drugs
Looking Backward & Looking Ahead:
NDAs, ANDAs, DESI Drugs
Rebecca L. Dandeker
Of Counsel
Washington, DC
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NDA REVIEWS
PAST
Collaborative
User Fee System Creates
Stakeholders
NOW
Congress highlighting safety
problems
Industry viewed as bad actors
Media hyping FDA s lost
reputation = No Collaboration
But Sharfstein reported to be
collaborator will it trickle down
to reviewers?
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PRODUCT DEVELOPMENT
PAST
NDAs
Long IND Times
Short Review Times
10-12 Month Approval
Times
ANDAs
Short Development Times
Long Review Times
17-24 Month Approval
Times
Domestic Inspections
NOW
NDAs = same
ANDAs = same
More Pressure for User Fees
Industry Can t Withstand the
Delays Anymore
OGD Reported a 17 Month
Median Time to Approval in
2006 Then Stopped
Reporting
Foreign Inspections
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RISK MANAGEMENT
PAST
Adverse Events collected,
reviews were slow
FDA struggles with its
authority
Cautious Implementation
Approvals with Labeling
Limitations
NOW
Adverse Events reviewed,
more FDA-initiated labeling
changes
Full Statutory Authority of
REMS
But Pendulum will still swing
between company-sponsored
product withdrawals vs. Use of
REMS
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BASIC APPROVAL PROOFS FOR THE MARKET
(BEYOND FDA)
PAST
NOW
Safety & Efficacy
State Formulary Inclusion
Pharmacy Benefit Managers
Pediatric Data
Past Items, Plus:
Post-market studies
Reimbursement Decisions
(CMS and Private Insurers)
Comparative Effectiveness
REMS
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NON-NDA DRUGS
PAST
Slow Movement on DESI
drugs, whether approval or
enforcement action
NOW
Increased enforcement actions
to remove DESI drugs
Significant efforts to convert
DESI drugs to approved NDAs
Product development
requirements?
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OTC MONOGRAPH DRUGS
PAST
10-20 Years with Monographs
Ongoing (Tentative Final
Monograph)
Very slow progress
NOW
More Activity, but still slow
Finalizing Monographs (or
parts), e.g., cough cold
combos, pediatric labeling,
internal analgesics
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PACE OF FDA WORK
PAST
Slow
Then slightly faster due to
Congressional interest
Via efficiencies but not a
change in FDA culture
White House oversight
NOW
Sharfstein Fast Pace
24/7 blackberries
Quick decisions on enforcement
actions
Faster turnaround for documents
(NDA, guidance, press releases,
letters)
Collapse the Timeline
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SAFETY-RELATED ENFORCEMENT ACTIONS
PAST
Voluntary Recalls, Followed
By Negative Publicity from
FDA
Recall Announcements viewed
by pharmacists, some
physicians
NOW
More Pressure for Recalls
from FDA
More Negative Publicity by
FDA
Recall Announcements viewed
by many more, e.g.,
shareholders, media,
competitors, contractors,
customers
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PURPOSEFUL ADULTURATION (ECONOMIC)
PAST
Not on FDA s Radar
More concerned about
counterfeiting
Government led
investigations
NOW
DMF, Source Material (foreign)
Bad Actors are expected by
FDA
Highlighted by Congress
Industry s responsibility to
investigate and guard against,
per suppliers
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PhRMA
PAST
Accepted
Then Watched and
Reported but Permitted
Patient Groups as
Proponents of Change
PHYSICIAN TIES
NOW
Automatically Suspect
Ties Being Cut
With States Leading in
enforcement and change
Congress Also a Proponent of
Change
Sharfstein also a proponent of
change (?)
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TRANSPARENCY
PAST
Lip Service Only
FDA would not disclose
confidential and proprietary
product information, NDAs
NOW
Announced Goal of Obama
Administration (?)
FDAAA of 2007 FDA must
post drug labeling, drug
approval package, clinical trial
registry data summaries,
brand/generic agreements
(authorized generics)
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CONGRESSIONAL FOCUS
PAST
Faster Drug Approvals
Underrepresented Patients
(Orphans)
Industry As Useful
NOW
Safety, REMS
Limitation to Patients
Industry as Detrimental
FDA failing to fulfill its mission
of protecting the public
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CHANGES TO STATUTE
PAST
NOW
Infrequent
1906, 1938, 1962, 1984
Frequent
1992, 1996, 1997, 2002, 2003,
2006, 2007, 2008
But takes FDA 5 years to
implement each change
Unfunded mandates
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CONCLUSION
Pendulum swings throughout history between an emphasis on
safety, and an emphasis on finding and approving new therapies
quickly
Successful companies will accept this fact, and move projects back
and forth between short term and long term categories, based on
the pendulum
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Any questions or comments?
Rebecca Dandeker, Of Counsel (DC)
(202) 778-9409 (ph)
(202) 778-9100 (fax)
rebecca.dandeker@klgates.com
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Lunch and Speaker
Introduction:
George Burditt, K&L Gates, Chicago
Lunch Speaker:
Scott MacIntire, District Director, Food & Drug Administration
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