Tuesday, June 7, 2011

Vol. 1 No. 11: Did FDA Apply a Remedy Worse than the Disease in Refusing to Clear the Market of Unapproved Versions of Makena?

Did FDA Apply a Remedy Worse than the Disease in Refusing to Clear the Market of Unapproved Versions of Makena?

Sheldon T. Bradshaw, Partner, Hunton & Williams LLP
Kyle Sampson, Partner, Hunton & Williams LLP
Brian J. Wesoloski, Associate, Hunton & Williams LLP

The authors discuss the unapproved (compounded by pharmacists) versions of Makena that remained available after FDA approval and express concern that the agency did not take enforcement action against these drugs.

The authors specifically recommend that FDA should:
  • Publicly acknowledge that its decision not to take enforcement action against pharmacies marketing unapproved versions of Makena was erroneous and reverse that decision.
  • Reaffirm its long-standing position that “traditional pharmacy compounding” does not include the compounding of commercially available drug products.
  • Advise consumers to avoid compounded drug products when an FDA-approved product is available.
  • Clear the market of unapproved drug products that undermine 1) the value of ODA exclusivity and 2) the incentives to study orphan drug indications.

This article is available for download at http://fdli.org/pubs/policyforum/ now. All issues of FDLI's Food and Drug Policy Forum are free to FDLI members and can be purchased by non-members.

If you have any difficulty posting your comment, please contact Sarah Sansolo at sks@fdli.org.

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