Drugs

FDA ‘Cut Corners’ to Approve Hetlioz ANDA: Vanda

David McFarland

— 2 min read
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Vanda Pharmaceuticals says it has uncovered a “striking example of … generic corner-cutting and regulatory looking-the-other-way for an ANDA application submitted by MSN Pharmaceuticals seeking to market a generic equivalent to Vanda’s product Hetlioz (tasimelteon).” In a suit against FDA and HHS filed in DC federal court, the company says that although FDA has consistently informed ANDA applicants that an appropriately designed bioequivalence study must include subjects reflecting the demographic of the intended population, MSN only tested its generic form of Hetlioz in 44 Indian males.

“MSN did not include any females or any non-Asian males,” the suit says, “despite seeking to market its generic tasimelteon product to men and women in the United States. In complete disregard of its own policies and requirements reflected in its guidance and accepted principles of bioequivalence, FDA rubberstamped MSN’s bioequivalence study. It turned a blind eye to further deficiencies in the study design, such as a failure to blind the study, and to serious discrepancies in the data that indicate that either MSN’s reference product in its study was not Hetlioz or systematic errors infected the study.” The suit also says the MSN product was not approved by an individual with political accountability for approving generic drugs, in direct contravention of the Appointments Clause in Article II of the U.S. Constitution.

Vanda argues that the authority to approve or deny an ANDA application is an exercise of significant authority under U.S. law and thus approvals and denials should be by officers of the United States. Its suit says the MSN ANDA was signed on letterhead by CDER Office of Regulatory Operations director Edward Sherwood, while the actual signature on the approval is by John Ibrahim, the Office of Regulatory Affairs associate director for regulatory affairs, who reports to Sherwood. Vanda’s position is that since neither Sherwood nor Ibrahim were appointed by the President with the advice and consent of the Senate, they cannot lawfully approve an ANDA.

Vanda says the agency’s approval of the MSN ANDA was unlawful and poses serious safety risks to public health. “Absent the information necessary to establish bioequivalence in the entire patient population,” the suit says, “the safety and effectiveness of MSN’s drug cannot be assumed, and may result in less effectiveness and greater and more severe adverse events than in patients taking Hetlioz.”

Vanda asks the court to:

  • declare that FDA’s approval of the MSN ANDA was unlawful and a violation of the Federal Food, Drug, and Cosmetic Act and FDA regulations;
  • declare that FDA’s approval of the ANDA was arbitrary and capricious;
  • declare that FDA’s approval of the ANDA was contrary to law or constitutional power;
  • vacate FDA’s approval of the MSN ANDA;
  • compel FDA to order MSN to immediately recall all shipments or sales of its generic form of Hetlioz and cause the product to be destroyed or relabeled in a way that complies with the law and regulations; and
  • award Vanda such further and additional relief as the court deems just and proper.

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