ARTICLE | Politics & Policy

Vermont sues FDA over reimportation

August 20, 2004 7:00 AM UTC

The state of Vermont said it filed suit against FDA in the U.S. District Court for the District of Vermont claiming that the agency's decision not to authorize a state-run pilot drug reimportation plan was "arbitrary and capricious" and in "direct violation of" the Medicare Prescription Drug, Improvement and Modernization Act (MMA). Under the act, the federal government is required to establish rules to allow the reimportation of drugs from Canada for wholesalers, pharmacists and state benefit programs.

According to the suit, FDA has said that such rules would be ineffective until the Secretary of Health and Human Services (HHS) certifies to Congress that imported drugs will not pose a risk to public health and safety. Vermont also alleges that FDA violates the U.S. Constitution by "improperly delegating legislative power to the Secretary of HHS, an official of the Executive Branch. Once FDA is served with the suit, the agency will have 60 days to respond. ...