News

FDA Waiting for Permanent Drug Manufacturing Injunction to Actavis

The FDA released that it filed a consent and is awaiting the entry of a permanent injunction against Actavis Totowa, LLC, Actavis, Inc., and their officers, Sigurdur Oli Olafsson and Douglas Boothe, from manufacturing and distributing drugs at the Actavis Totowa facilities. The injunction is to remain in effect until Actavis Totowa meets compliance with the United States Good Manufacturing Practice (cGMP) requirements, and then seeks to obtains the Food and Drug Administration's approval to again manufacture and distribute drugs in to the U.S.

The defendants had to sign a decree that permits them to resume operations for only three categories of drugs. Only after an expert certifies that the drugs comply with the CGMP requirements will they then be able to:

A) Have the approval of the Food and Drug Administration.
B) The Food and Drug Administration inspects to confirm compliance with the law.

The decree also mandates the defendants to comply with the destruction of any and all remaining pharmaceuticals which were recalled from the months of April to July 2008, that they are currently in possession of.

Janet Woodcock, M.D., and director for the Center for Drug Evaluation and Research, FDA. stated,

"The FDA will not allow manufacturers to put the public's health at risk ... These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks ..."

The consent decree also authorizes FDA to order the defendants to cease operations in the event of future violations. It further subjects the defendants to liquidated damages of $15,000 per day if they fail to comply with any of the provisions of the decree, and to the payment of an additional $15,000 for each violation, up to $7 million per year.

"The FDA will carefully monitor the provisions of this injunction to ensure compliance ... "

said Michael Chappell, FDA acting associate commissioner, Office of Regulatory Affairs.

"Companies should know that FDA will investigate and take action against other marketers of unapproved drugs ... "

The government's complaint, filed Nov. 14, 2008, by the U.S. Department of Justice in the District Court for the District of New Jersey, alleged that the defendants violated the Federal Food, Drug, and Cosmetic Act by not complying with cGMP requirements and failing to obtain FDA's approval of some of its drugs, two requirements designed to ensure the safety, effectiveness, and quality of pharmaceutical products.