Presentation to the LARTA (www.larta.org) NIH-CAP Workshop in October 2007 on how to develop FDA-regulated products, with a focus on planning, working with FDA, regulatory pitfalls, clinical studies, etc.

1. FDA Regulatory Considerations
for the Biomedical Companies
Michael A. Swit, Esq.
Vice President, Life Sciences
LARTA
NIH-CAP COMMERCIALIZATION WORKSHOP
Marina Del Rey, California
October 17, 2007

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ANCIENT CHINESE CURSE
May You Live in Interesting Times …

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THESE ARE INTERESTING
REGULATORY TIMES
• September 30, 2004 – the beginning of the
current era of drug regulation
– Vioxx
– SSRI’s and suicidal ideation
• Since then:
– Tysabri
– Avandia
• New Lynchpin of Regulatory Process –
Drug Safety

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INTERESTING REGULATORY
TIMES …
• FDA Leadership
– Top -- In disarray
• 2004 -- McClellan left to go to CMS; Crawford interim
Commissioner
• Summer 2005 – Crawford confirmed by Senate
• Sept. 2005 – Crawford abruptly resigns
• 2006 – Andrew von Eschenbach becomes acting
• December 2006 – von Eschenbach confirmed
• Sept. 2007 – General Counsel resigns
– Deputies & Associates – many leave at end of 2006

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The Perfect Storm?
• The Current FDA Regulatory Equation -- (Drug Safety
Lynchpin) + (Leadership Vacuums) = an approval process mired
in uncertainty, fear and decision paralysis
PLUS
• A Democratic Congress
PLUS
• September 30, 2007 – Deadline Day
– PDUFA Reauthorization Sunsets
– Pediatric Exclusivity and Pediatric “Rule” Sunsets
EQUALS
• Congress in driver’s seat to drive change??
– But, still have 2 more years of Bush

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The Result – FDAAA
• FDAAA -- Food and Drug Administration
Amendments Act of 2007 -- H.R. 3580 (422
pages)
• Negotiated compromise – passed House on
September 20 and Senate on September 21
• Signed by President on Thurs., September 27,
2007
• Public Law 110-85

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Key Provisions for Drug Industry
• PDUFA Reauthorization
• Prescription Drug Advertising Review Fees
• DTC Advertising Penalties
• Drug Safety Provisions
• Clinical Trials Registry & Results Data Base
• Critical Path Initiative – Reagan-Udall Foundation
• Pediatric Exclusivity and Pediatric “Rule” Reauthorization
• Citizen Petitions – limits FDA authority to delay
approvals
• Biosimilars – NOT COVERED by FDAAA

8. FDA's Three Key Development
Roles:
• "Gatekeeper" to the marketplace -- the new drug
approval process
• "Cop on the beat" or "Enforcer" -- ensuring
quality compliance via inspection and
enforcement actions (e.g. criminal charges)
• "Sentinel" of Safety Concerns - during
development and post-approval
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9. What Data – Quantity & Quality –
Will FDA Require?
• Will vary -- FDA has extensive discretion
here
• Key task -- try to get clarity as soon as
possible in the process -- Ways to do so:
– Pre-IND or Pre-IDE meeting -- encouraged by FDA
prior to start of human clinicals
– End of Phase 2 Meeting - also encouraged -- here's
where you want to "lock" them in
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10. What Data – Quantity & Quality
– Will FDA Require?
• FDAMA § 119(a) --
– FDA must meet with you on design of studies; and
– Any agreement on study design must be written and
can't be changed later w/o your consent unless a
new safety or effectiveness issue arises later
– “Special Protocol Assessments” – FDA process for
implementing – aka “SPA” (see Slide 7)
• FDAMA § 115(a) -- data from one adequate and well-
controlled study and confirmatory evidence can be used
to show substantial evidence of effectiveness
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11. What Data – Quantity &
Quality – Will FDA Require? …
• "Pure" proof of clinical effectiveness
may not be needed -- e.g., under “Fast
Track,” may be able to use:
– Surrogate endpoints
– Clinical endpoints
– Phase IV study will be needed usually
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The SPA – Panacea or Pablum?
• Good news – you theoretically have FDA
locked in
• Bad news – FDA is locked in to your plan and,
if problems arise in clinicals, are you boxing
your firm in to a lack of flexibility?

13. The FDA Review -- Priority
and Speed
• "Fast Track" -- FDAMA § 112
– treats a "serious or life threatening condition"
– shows "potential to address unmet medical
needs for such condition"
– If so, FDA must "facilitate the development and
expedite and review" of the drug
– Request at time of or after IND filing
See 1998 Guidance on Fast Track
http://www.fda.gov/cder/guidance/2112fnl.pdf
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The FDA Review – Key Issues
Impacting Speed & Criteria
• Vioxx Backlash –
– FDA –
• Now Very Risk adverse
• Slower
• Leadership fragmented – Crawford resignation
– “New” or “Renewed” “Regulators”
• Congress – as now seen via FDAAA
• Products Liability Lawyers
• U.S. Attorneys
• States Attorney General
• “Qui Tam” relators

15. Tips to avoid problems & speed
review
• Make sure R&D and Sales & Marketing are talking
early on -- ensure the indication being studied is one you
want to sell
• Understand, that an approval is not enough – you need
to get Medicare &/or private payer reimbursement
– Start the reimbursement qualification process early
– Design clinical protocols to address payer expectations
• Private & Government
• Example -- study your drug in Medicare-age patients
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16. Tips to avoid problems & speed
review…
• Make sure you are ready to go to “D” from “R” –
– Internally – people and systems
– Formulation has been rigorously reviewed so as to optimize your
chances when going into humans
• Study and file electronically, if possible
• Respond to FDA deficiency letters during review
promptly, fully, and honestly
– Know how the system works – if you don’t agree with a
reviewer’s decision, work up the chain of command
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17. Tips to avoid problems & speed
review…
• If outsourcing, audit aggressively your "vendors:”
– CROs, clinical investigators, contract manufacturers, API makers
– IRBs – they have been shut down in past
– Joint venture partners – e.g., Cialis® – Lilly manufacturing plant
problems – delayed about one year
– Remember – even when you outsource, you are still ultimately
responsible for what happens and you still need to have systems
and people in place to ensure your vendors are working correctly
• Don't bury your head to problems -- investigate and
disclose promptly
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Tips to avoid problems & speed
review…
• Don’t fall madly in love with your technology –
understand that you have to prove safety and
effectiveness – “I just know it works” is not the
standard
• The process is very complex – this is a mere overview
– build the right team to tackle
– But, be careful with involving lobbyists,
Congressmen/women, etc., at any stage

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Call, e-mail, fax or write:
Michael A. Swit, Esq.
Vice President, Life Sciences
THE WEINBERG GROUP INC.
336 North Coast Hwy. 101
Suite C
Encinitas, CA 92024
Phone 760.633.3343
Fax 760.454.2979
Cell 760.815.4762
michael.swit@weinberggroup.com
www.weinberggroup.com
Questions?

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About your speaker…
Michael A. Swit, Esq., is Vice President, Life Sciences at THE WEINBERG GROUP, where he develops and ensures
the execution of a broad array of regulatory and other services to drug and biologics clients seeking to market
products in the United States. His expertise includes FDA and CMS development strategies, compliance and
enforcement initiatives, recalls and crisis management, submissions and related traditional FDA regulatory activities,
labeling and advertising, and clinical research efforts.
Mr. Swit has been addressing critical FDA legal and regulatory issues since 1984. His multi-faceted experience
includes serving for three and a half years as corporate vice president, general counsel and secretary of Par
Pharmaceutical, a prominent, publicly-traded, generic drug company and, thus, he brings an industry and commercial
perspective to his work with FDA-regulated companies. Mr. Swit then served for over four years as CEO of
FDANews.com, a premier publisher of FDA regulatory newsletters and other specialty information products for the
FDA-regulated community. His private FDA regulatory law practice has included service as Special Counsel in the
FDA Law Practice Group in the San Diego office of Heller Ehrman White & McAuliffe and with the Food & Drug
Law practice at McKenna & Cuneo, both in the firm’s Washington office and later in San Diego. He first practiced
FDA regulatory law with the D.C. office of Burditt & Radzius.
Mr. Swit has taught and written on a wide variety of subjects relating to FDA law, regulation and related commercial
activities, including, since 1989, co-directing a three-day intensive course on the generic drug approval process and
editing a guide to the generic drug approval process, Getting Your Generic Drug Approved. A former member of the
Food & Drug Law Journal Editorial Board, he also has been a prominent speaker at numerous conferences sponsored
by such organizations as RAPS, FDLI, and DIA. A magna cum laude graduate of Bowdoin College, he received his
law degree from Emory University Law School and is a member of the California, D.C. and Virginia bars.

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