SILVER SPRING, Md. Drug maker Forest Pharmaceuticals will pay more than $300 million to the federal government as part of a plea agreement over alleged improper drug distribution and obstructing a Food and Drug Administration inspection.
The FDA said Wednesday that Forest Pharmaceuticals, a subsidiary of New York-based Forest Labs, had entered a plea agreement whereby it would accept criminal responsibility for distribution of an unapproved drug, distribution of a misbranded drug and obstruction of an FDA inspection. The total payment of $313 million includes $164 million in criminal penalties.
One charge centered around the marketing of Levothroid (levothyroxine sodium), an unapproved drug used to treat hypothyroidism. A 1997 Federal Register notice announced that Levothroid is a “new drug,” and that manufacturers who wish to continue marketing it would have to obtain approval from the FDA by August 2000.
The company also is charged with alleged off-label promotion of the antidepressant Celexa (citalopram) for use in children; the drug is only approved for use in adults. The charge of obstructing an FDA inspection relates to an alleged 2003 incident in which Forest employees made false statements to the agency.
“We are pleased to bring closure to this long-running investigation,” Forest chairman and CEO Howard Solomon said. “We remain dedicated to ensuring that we operate in full compliance with all laws and regulations and that our employees uphold the highest principles of integrity, honesty and ethics.”