Overview of FDA's Regulatory Compliance Agenda

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Overview of FDA's Regulatory Compliance Agenda

• Daniel Meron, Esq.
• General Counsel
• Department of Health and Human Services
• August 22, 2007

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Topics

• Regulation of Drug Compounding
• Enforcement Regarding Unapproved Drugs
• Off-Label Promotion Investigations and
  Enforcement
• Preemption

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Drug Compounding

• Traditional drug compounding
• FDCA definition of new drug
• Any drug the composition of which is not
  generally recognized as safe and effective
• FDAs enforcement discretion policy
• Traditionally defer to state regulation regarding
  compounded drugs
• 1992 Compliance Policy Guide (CPG)

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Drug Compounding

• FDCA Section 503A exempted compounded drugs from
  certain requirements of the FDCA, including new
  drug approval, if
• Drugs compounded in response to a valid
  prescription for an identified patient
• Prepared in limited quantities in advance of
  prescriptions based on a history of receiving
  prescriptions for that product
• Prohibited advertising the availability of
  specific compounded drugs or soliciting
  prescriptions

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Drug Compounding

• Thompson v. Western States Med. Center
• Speech provisions of 503A are unconstitutional
• Ninth Circuit Speech provisions cannot be
  severed
• 2002 Compliance Policy Guide
• Medical Center Pharmacy v. Gonzales
• District Court holding
• Section 503A is valid
• FDCA implicitly exempts compounded drugs from the
  definition of new drugs
• On appeal to the Fifth Circuit

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Unapproved Drugs

• Prevalence of unapproved drugs
• 2006 CPG on unapproved drugs
• Risk-based enforcement strategy
• Factors that FDA will consider
• Drugs with potential safety risks
• Drugs that lack evidence of effectiveness
• Drugs that are fraudulently promoted
• Drugs that challenge new drug approval process
• Recent enforcement examples

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Off-Label Promotion

• Legal background
• Drugs must be approved for each intended use
• Promotion of a drug for an unapproved use can
  cause it to be misbranded, unapproved
• Example Investigation into off-label promotion
  for Evista
• Improper use of reprints to promote off-label
• Improper use of consultant meetings

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Preemption

• FDA approves labeling for a drug, including the
  precise wording of warnings
• Manufacturer must use FDA-approved labeling
• Use of non-FDA-approved labeling could misbrand
  product
• CBE supplement provision is a limited exception
  to general rule of advance FDA-approval

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Colacicco v. Apotex

• Plaintiff alleged that manufacturer should have
  provided different warnings regarding suicide
  risks for paroxetine hydrochloride
• FDA had previously considered and rejected
  stronger warnings
• FDAs amicus brief
• Use of different warnings would have violated
  federal law
• CBE supplement would not have been appropriate

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Potential Preemption Cases Before the Supreme
Court

• Riegel v. Medtronic
• Device preemption
• Certiorari granted
• Levine v. Wyeth
• Drug preemption
• Court considering whether to grant certiorari