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THE REGULATORY HORIZON . Pharmaceutical Education Associates Drug Delivery Conference San Diego, California June 6, 2007. Michael A. Swit, Esq. Vice President, Life Sciences. ANCIENT CHINESE CURSE. May You Live in Interesting Times …. THESE ARE INTERESTING REGULATORY TIMES.

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the regulatory horizon


Pharmaceutical Education Associates

Drug Delivery Conference

San Diego, California

June 6, 2007

Michael A. Swit, Esq.Vice President, Life Sciences

ancient chinese curse

May You Live in Interesting Times …


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


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
    • Deputies & Associates – many leave at end of 2006


the perfect storm
The Perfect Storm?
  • The Current FDA Regulatory Equation -- (Drug Safety Lynchpin) + (Leadership Vacuums) = an approval process mired in uncertainty, fear and decision paralysis


  • A Democratic Congress


  • September 30, 2007 – Deadline Day
    • PDUFA Reauthorization Sunsets
    • Pediatric Exclusivity and Pediatric “Rule” Sunsets


  • Congress in driver’s seat to drive change??
    • But, still have 2 more years of Bush


the result fdara
The Result -- FDARA
  • “The Food & Drug Administration Revitalization Act” – S. 1082
  • Introduced in Senate in April – Jointly by Kennedy (D-MA) and Enzi (R-WY)
  • Passed Senate on May 9 – Vote: 93-1
  • Hearings in House Expected in Next Weeks – although not yet introduced formally in House
    • Dingell may want to consider separately


key provisions for drug industry
Key Provisions for Drug Industry
  • PDUFA Reauthorization
  • Prescription Drug Advertising Review Fees
  • Drug Safety Provisions
  • Clinical Trials Registry & Results Data Base
  • Critical Path Initiative – Reagan-Udall Foundation
  • Antibiotic Development Incentives
  • Pediatric Exclusivity and Pediatric “Rule” Reauthorization
  • Tropical Disease Incentives
  • Citizen Petitions – limits FDA authority to delay approvals
  • DTC Advertising Penalties
  • Drug Importation
  • Biosimilars – “Sense of Senate” Endorsement


pdufa reauthorization title i
PDUFA Reauthorization – Title I
  • Goals
    • Expedite drug development process
    • Expedite application review process
    • Postmarket Drug Safety
  • Gross Fees
    • $392 MM annually in User Fees
    • $150 MM in fees over 5 years for Drug Safety
    • $6 MM for TV ad advisory reviews


prescription drug advertising advisory review fees
Prescription Drug Advertising “Advisory” Review Fees
  • Must pay if you submit a TV ad for “advisory review” (but, don’t have to submit for review)
  • “Advisory review” = “reviewing and providing advisory comments regarding compliance of a proposed advertisement
  • If required to submit, you do not have to pay, unless you say it’s for “advisory review”
    • No separate authority given FDA to require submission
  • FY 2008 – maximum fee is $83,000 per ad submission
  • Sunsets – October 1, 2012


drug safety title ii
Drug Safety – Title II
  • Risk Evaluation and Mitigation Strategies (“REMS”) – Section 202 of FDARA adds in a new clause in Federal Food, Drug, and Cosmetic Act (“FFDCA”) – Section 505(o)
  • If a REMS is OK’d for an application, must follow it
  • You can voluntarily submit a REMS
  • FDA may require if viewed as needed to assess a safety signal or to mitigate it
    • Decision to require a REMS must be made at or above the division director level in CDER


drug safety
Drug Safety …
  • Required Elements of a REMS
    • Labeling
    • Timetable for submitting assessments of ongoing strategy
      • NCE – no less frequently than 18 mos. and 3 years post-OK
      • Non-NCE – at frequency determined by FDA
    • Risk Evaluation Strategies
      • Post-approval studies (other than clinicals)
      • Post-approval clinical trials


drug safety12
Drug Safety …
  • Elements of a REMS … may include:
    • Communication Elements – such as:
      • Medguide – 21 CFR 208
      • Patient Package Insert
      • Communication Plan – to health care providers (e.g., via letters)
    • Pre-review of advertising – may be required by FDA if determined needed to ensure “fair balance”
    • FDA may order certain disclosures added to ads
    • Patient Registries


drug safety13
Drug Safety …
  • Elements of a REMS … may include …:
    • Patient monitoring
    • Certification of prescribers, pharmacies or health care settings
    • Restriction of dispensing to certain health care settings
    • Condition dispensing based on certain test results
  • Failure to “knowingly” comply
    • Drug misbranded
    • Civil Penalties -- $15M to $250M per violation to a cap of $1 MM per violations determined in a single adjudication
  • Applies to Biologics approved under Public Health Service Act


drug safety14
Drug Safety …
  • Duty on application holders to notify FDA of “new safety information” holder “believes should be included in the labeling” – and vice-versa (FDA to application holder)
    • Holder and FDA shall initiate discussions on labeling changes
    • FDA may request a supplement be submitted


post market drug safety information
Post-Market Drug Safety Information
  • Comprehensive website with information on approved drugs, including:
    • “easily searchable” info from Medline, etc.
    • Patient labeling and PPIs
    • List of drugs requiring MedGuides
    • Link to Clinical Trials Registry Data Bank
    • “most recent” FDA safety info


action package for approval
Action Package for Approval
  • FDA must publish within 30 days of approval of an NCE
  • Summary Reviews – within 48 hours of NDA approval – must note any critical issues and disagreements with the applicant and how resolved
  • Reviewer’s review – can not be altered once finalized (but, “finalized” is not defined)
  • Disagreements among review staff and supervisors must be documented


critical path initiative reagan udall foundation
Critical Path Initiative – Reagan-Udall Foundation
  • Section 221 of FDARA
  • Not part of U.S. Government, but funded in part by FDA budget
  • “To advance mission of FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.”
  • Promote research into unmet needs in those areas


expanded clinical trials registry data bank
Expanded Clinical Trials Registry Data Bank
  • 18 months after enactment, regulations required to require submission of “clinical trial information” on any drug or biologic in a Phase 2 or above study
  • Information – consistent with that required by WHO, plus:
    • Contact information
    • Information on whether “expanded access” possible


clinical trial results database
Clinical Trial Results Database
  • Applies to clinical studies “forming the primary basis” for an efficacy claim or conducted after approval
  • Required info includes:
    • Any FDA advisory committee deliberations
    • FDA Action Package on NDA/BLA
    • Links to Medline data


antibiotic drug development incentives
Antibiotic Drug Development Incentives
  • Liberalizes ability to get exclusivity for “older” antibiotic products


pediatric provisions
Pediatric Provisions
  • “Reauthorizes” the Best Pharmaceuticals in Children Act (“BPCA”) through FY 2012 – Section 505A of the FFDCA
    • FDA may request preclinical studies
    • Exclusivity changes:
      • 3 months limit if annual U.S. sales > $1 billion
      • No exclusivity grant if less than 9 months left on existing
      • FDA must disclose detailed reviews of the studies


pediatric provisions22
Pediatric Provisions …
  • “Pediatric Research Improvement Act” – Section 411 of FDARA
    • Reauthorizes the 2003 Pediatric Research Equity Act (PREA) through FY 2012
    • Calls for FDA to establish an internal committee for evaluating actions under PRIA including requests by FDA for pediatric assessments and deferral/waiver requests by industry
    • Pediatric labeling supplements deemed “priority” reviews
    • “Meaningful therapeutic benefit” standard (relates to waivers) changed
      • FDA must “determine” – was “estimate”
      • Drug “could” (was “would”) represent a significant improvement over existing labeled therapies
  • Caution – don’t promise the sun, start with a few meteors (e.g., PK studies)


hiv and tropical disease incentives
HIV and Tropical Disease Incentives
  • Adds Section 524 of FFDCA
  • Applies to drugs for HIV, malaria, TB, and “any other infectious disease that disproportionately affects poor and marginalized populations” including tropical diseases
  • “Priority Review Voucher” created
    • Does not relate to the NDA for the tropical disease itself (which arguably gets priority review status anyway)
    • Can be transferred or sold to a third party
    • Original recipient or third party can use for any NDA


citizen petitions
Citizen Petitions
  • Adds a new Section 505(s) to the FFDCA
  • FDA cannot delay approval based on a citizen petition unless FDA determines, within 25 business days of receipt, that a delay in necessary to protect the public health
  • If FDA so determines, must:
    • Put detailed statement of reasons on FDA website
    • Must give 505(b)(2) or generic applicants chance for a meeting – send notice of chance for meeting within 10 days of making determination
  • Petition decisions must be made in 180 days unless delay needed to protect public health


dtc advertising civil penalties
DTC Advertising – Civil Penalties
  • Adds Section 303(g) to FFDCA – civil penalties for false or misleading DTC ads for a prescription drug (not a device)
  • Penalty –
    • Up to $150,000 on first offense in a 3-year period
    • Up to $300,000 on later offenses
  • FDA must give a chance for a hearing


drug importation
Drug Importation
  • “Pharmaceutical Market Access and Drug Safety Act of 2007” – adds Section 804 to FFDCA
  • Allows importation under limited circumstances
    • Drug must be identical to an approved U.S. drug (API, dosage form, etc.); excludes:
      • Controlled substances
      • Biologics
      • Infused, injected or sterile ophthalmic drugs
      • Listed drug for which there are 2 approved ANDAs in U.S.
    • For personal use
    • For commercial use
      • By “registered importers”
      • From “registered exporters”
      • Directly obtained from the make and made in registered facilities
    • From a “permitted country” – Australia, Canada, Japan, New Zealand, Switzerland, most EU countries, and other countries cleared by FDA


biosimilars sense of senate endorsement
Biosimilars – “Sense of Senate” Endorsement
  • Section 504 of FDARA
  • Legislation should be enacted
    • to give FDA authority and flexibility to approve biopharmaceuticals subject to an abbreviated approval pathway
    • ensure patient safety remains paramount
    • establish a pathway that is “efficient, effective and scientifically-grounded and includes measures to ensure timely resolution of patent disputes
    • provides appropriate incentives for R&D of biopharmaceuticals


stay tuned
Stay Tuned …
  • If not PDUFA reauthorization not passed by end of July, FDA must send out RIF notices
  • We are in interesting times ….




Call, e-mail, fax or write:

Michael A. Swit, Esq.

Vice President, Life Sciences


336 North Coast Hwy. 101

Suite C

Encinitas, CA 92024

Phone 760.633.3343

Fax 760.454.2979

Cell 760.815.4762

D.C. Office 202.730.4123


about your speaker
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, 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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