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KV Sues FDA over its Interpretation and Application of Orphan Drug Exclusivity, Drug Compounding, Unapproved Drugs, and Import Provisions

Brian C. Stone

16 July 2012
K-V Pharmaceutical Company (“KV”) and its wholly-owned subsidiary, Ther-Rx Corporation (“Ther-Rx”) filed suit in the U.S. District Court for the District of Columbia on July 5, 2012 against the FDA seeking declaratory and injunctive relief to “restore” KV’s 7-year orphan drug exclusivity for MAKENA (hydroxyprogesterone caproate or 17P) Injection, 250 mg/mL. 
KV Sues FDA over its Interpretation and Application of Orphan Drug Exclusivity, Drug Compounding, Unapproved Drugs, and Import Provisions

By way of background,

  • MAKENA was approved on February 3, 2011 to decrease “the risk of certain preterm births in women who have had at least one prior preterm birth” MAKENA was also granted orphan drug exclusivity under 21 USC § 360CC.  Therefore, KV has a 7-year period of drug exclusivity set to expire on February 3, 2018.
  • Following approval and the grant of exclusivity, MAKENA was initially priced at $1,500 per dose or approximately $300,000 for each pregnancy, even though 17P had been available for many years from pharmacist who compound the sterile injectable drug for individual patients when medically necessary. 
  • There was a public outcry regarding the price of MAKENA, KV lowered the price to $690 per dose.
  • On March 30, 2011, the FDA issued a press release declaring FDA’s policy “to support access” to HPC injections by not taking enforcement action against pharmacists who compound the drug. 
  • On the same day, CMS released a statement informing States and Medicaid payers that they “can choose to pay” for the compounded 17P notwithstanding the availability of MAKENA. 

The government’s actions lead to KV filing suit.  KV’s lawsuit is worth keeping a close eye on because it challenges FDA in four key areas:

  1. Orphan Drug Exclusivity: KV alleges the FDA’s enforcement policy violates the orphan drug seven year period of market exclusivity by giving de facto approval to non-medically necessary compounded versions of 17P;
  2. Drug Compounding: KV alleges the compounding policy is contrary to the express statutory limitations on compounding which permits a licensed pharmacist may compound a drug product for an “identified individual patient based on the unsolicited receipt of a valid prescription order” that states the compounded product is necessary for that patient.  21 USC § 353A
  3. Unapproved Drugs: KV alleges the FDA’s policy “approve, authorize, invite, encourage, and permit the introduction, and delivery” of unapproved new drugs in interstate commerce, violates FDC Act §§ 505(a) and 301(d), which prohibit the marketing of a new drug without an effective approval; and 
  4. FDA’s Enforcement Discretion Regarding Imports: KV alleges that all or nearly all of the bulk material used to compound 17P is imported into the US from factories in China, and such importation violates violate FDC Act § 801(a), which states FDA “shall” prevent importation of unapproved drugs into the United States.  This challenge to FDA’s importation enforcement discretion is notable because it comes on the heels of Beaty v. FDA.  In Beaty, the D.C. District Court held FDC Act § 801(a) requires FDA to deny admission of imported drugs appearing adulterated, misbranded, or unapproved; a decision FDA is likely to appeal.

The Government’s brief is due July 20, 2012, and KV’s reply is due July 27, 2012, so stay tuned for further updates. The hearing is currently scheduled for August 7, 2012.

Brian C. Stone

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