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Overview of FDA's Regulatory Compliance Agenda

Overview of FDA's Regulatory Compliance Agenda. Daniel Meron, Esq. General Counsel Department of Health and Human Services August 22, 2007. Topics. Regulation of Drug Compounding Enforcement Regarding Unapproved Drugs Off-Label Promotion Investigations and Enforcement Preemption.

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Overview of FDA's Regulatory Compliance Agenda

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  1. Overview of FDA's Regulatory Compliance Agenda Daniel Meron, Esq. General Counsel Department of Health and Human Services August 22, 2007

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

  3. Drug Compounding • Traditional drug compounding • FDCA definition of “new drug”: • Any drug the composition of which is not generally recognized as safe and effective • FDA’s enforcement discretion policy • Traditionally defer to state regulation regarding compounded drugs • 1992 Compliance Policy Guide (CPG)

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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 • FDA’s amicus brief: • Use of different warnings would have violated federal law • CBE supplement would not have been appropriate

  10. 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

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