BioMarin Faces DOJ Scrutiny over Sponsored Testing Programs

Rare Daily Staff

Rare disease drug developer BioMarin said it received a subpoena from the U.S. Department of Justice requesting that it produce certain documents regarding its sponsored testing programs relating to two of its enzyme replacement therapies.

The company reported the subpoena in its annual report filed with the U.S. Securities and Exchange Commission. The testing programs relate to Vimizim, the company’s enzyme replacement therapy for the lysosomal storage disorder mucopolysaccharidosis type IVA and for Naglazyme, the company’s enzyme replacement therapy for the lysosomal storage disorder mucopolysaccharidosis VI.

BioMarin said it has produced documents in response to the subpoena and is cooperating fully.

The company noted that in the United States, the federal Anti-Kickback Statute makes it illegal for any person or entity, including a pharmaceutical company, to knowingly and willfully offer, solicit, pay or receive any remuneration, directly or indirectly, in exchange for or to induce the referral of business, including the purchase, order or prescription of a particular drug, for which payment may be made under federal healthcare programs, such as Medicare and Medicaid.

Under the federal Anti-Kickback Statute and related regulations, certain arrangements are deemed not to violate the federal Anti-Kickback Statute if they fit within a statutory exception or regulatory safe harbor. However, the exceptions and safe harbors are drawn narrowly, and practices that involve remuneration not intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor.

The company said it seeks to comply with safe harbor requirements, but that there is no assurance that such sponsored testing programs, or our other operations or programs, will not be found to violate such laws.