VT Loses Rx Drug Importation Fight

September 28, 2005 (PLANSPONSOR.com) - Vermont's lawsuit against the federal Food & Drug Administration (FDA) over its imported prescription drug policy has been thrown out.

BNA reports that US District Judge William Sessions, III of the US District Court for the District of Vermont dismissed the suit, saying the FDA did not act improperly in denying Vermont’s petition to allow it to set up a drug importation plan that would import cheaper drugs from Canada since drug importation is illegal under federal law.

The judge said in his opinion, according to BNA, that, in addition to being illegal under the Federal Food, Drug, and Cosmetic Act, the Medicare Prescription Drug, Improvement and Modernization Act (MMA) does not provide authorization for Vermont’s plan since the secretary of the Department of Health and Human Services (HHS) has not certified to Congress that importation is safe and effective, which is a prerequisite to importation under the act.   The court rejected Vermont’s argument that the certification required by MMA was only intended to apply to commercial importation rather than importation by individuals.

In addition, BNA reports, the court rejected the argument that the certification provision was unconstitutional since it improperly delegates legislative power to the executive branch.   Sessions also found that the HHS secretary had not unreasonably delayed action on the certification provision of MMA.

The suit filed in August 2004 was the first move by a state to sue the federal government regarding importation of prescription drugs (See  Vermont Sues FDA Over Drug Importation ).   The FDA had denied  Vermont’s December 4, 2003 citizen petition requesting FDA’s permission to establish a program for the importation of prescription drugs from Canada, BNA reports.   The state sought a court order requiring “prompt adoption of regulations and waiver guidance and appropriate consideration of Vermont’s proposed program.”

The opinion was issued in re: Vermont v. Leavitt, D. Vt., No. 2:04-cv-00206 (WKS), 9/19/05.

Despite the legality of the issue, many states have already passed measures to allow importation of prescription drugs from Canada and other countries (See  Illinois Becomes Fifth State to Import Prescription Drugs from Abroad ).