Legal, Ethical and Regulatory Developments for Compounding IACP: Promoting, Protecting, Advancing Ph

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Legal, Ethical and Regulatory Developments for
CompoundingIACP Promoting, Protecting,
Advancing Pharmacy Compounding
LD King Executive Vice President www.iacprx.org 2
81-933-8400 ldking_at_iacprx.org

• International Academy of Compounding Pharmacists

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Regulatory Update

• Compounding regulated by State Boards of Pharmacy
• States continue to update regulations
• State regs for compoundingCA, CO, KS, MD, MO,
  NE, NV, PA
• More states pointing to USP
• 18 States adopt or reference USP797 (see IACP for
  a list)
• FDA seeks control

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FDA ACTION AGAINST BHRT

• Wyeth files Citizen Petition to FDA in 2005
• 70,000 comments sent to FDA
• Vast majority ask FDA to reject petition
• FDA responds January 7-9, 2008
• Press conference
• (WSJ, Reuters, AP, USA Today, CBS, ABC,
  etc)
• Consumer outreach Bio-Identicals Sorting Myths
  from Facts
• 72 warning letters sent to compounding
  pharmacies

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BHRT at Risk

• FDA sends letter to suppliers of compounding
  pharmacies
• FDA will take action if distributing estriol
• FDA Import Alert
• Reimbursement providers stop payment to patients
• FDA claims their efforts do not ban estriol FDA
  merely requires and IND application and approval
  by IRB

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We are on the RIGHT side

•  Estriol
• Hundreds of thousands of patients
• Not one adverse event reported to FDA
• Legal and appropriate under all pharmacy
  standards
• Estriol has a USP monograph
• Recognized as legal by USP, PCAB, state boards of
  pharmacy and by Congress under FDAMA
• Currently in phase III trials to treat MS
• Used in Asia and Europe for years well supported
  in literature
• Sold by Wyeth in Europe

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Pharmacy Introduces Resolution

• Senate Resolution 88
• House Resolution 342
• Cosponsors 59

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 Resources

• www.iacprx.org/bhrtresources
• Literature review on estriol
• Developed legal position for warning letter
  responsesEstriol and bio-identical
• Supplier outreach joint letter to FDA
• Patient handout and talking points
• Reaching out to members of Congress
• FOIA request on information related to citizen
  petition response and FDA campaign
• Why FDAs IND doesnt work
• www.compoundingfacts.org
• www.FDAOverload.org
• www.savemyBHRT.org

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5th Circuit Court decides Midland

• 9th Circuit Court was wrong. Advertising
  restrictions are severable from 503A, leaving
  503A in place minus the advertising restrictions.
• Compounded medications for humans would be
  subject to FDA approval process if it were not
  for the exemptions found in 503A.
• Compounded medications for animals are subject ot
  the FDA approval process unless exempted by
  AMDUCA law.
• Plaintiff pharmacies are in the process of appeal
• 503A in place in the 5th Circuit. 503A remains
  struck down in the 9th Circuit. Ambiguity in the
  rest of the US.

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What does this mean

• Supreme Court could hear the case.
• Most likely outcome would be restoration of 503A
  (maybe 2 years)
• 503A does specifically allow compounding of
  estriol
• No relief for compounding for animals from active
  ingredients

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503AA Potential Nightmare?

• Compromised Legislation
• Demonstrably Difficult to Compound List
• Sterile compounding, narrow-therapeutic index,
  slow release capsules
• Positive list
• Metronidazole benzoate, piracetam,
  4-aminopyridine
• Interstate Restrictions
• Interpreted prohibitions against all compounding
  for office-use

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Options

• Wait for unrestrained FDA action in all but the
  5th Circuit
• Wait for Supreme Court to resurrect 503A for the
  entire US
• Wait for another organization or critic to
  sponsor new compounding legislation that applies
  nationally to fix the Circuit split
• Seize the opportunity to define the regulation of
  pharmacy compounding through new legislation

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IACP UpdateProtecting, Promoting, Advancing
Pharmacy Compounding

• International Academy of Compounding Pharmacists