FDA seeks closure of Actavis facilities for producing unapproved drugs
ROCKVILLE, Md. The Food and Drug Administration on Friday announced that it is awaiting the court entry of a permanent injunction against Actavis Totowa, following the filing of a Consent Decree on Dec. 23.
FDA is seeking to shut down three Actavis manufacturing facilities for not complying with good manufacturing practice requirements, stating that the drugs manufactured in those facilities are unapproved drugs. “The injunction will remain in effect until Actavis Totowa comes into compliance with U.S. current Good Manufacturing Practice requirements, and obtains FDA’s approval to manufacture and distribute drugs in the United States,” the agency said.
“The FDA will not allow manufacturers to put the public’s health at risk,” Janet Woodcock, director, Center for Drug Evaluation and Research, FDA said. “These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks.”
Actavis signed a consent decree that permits them to resume operations with respect to three categories of drugs only after an expert certifies that the drugs comply with the CGMP requirements and have FDA approval, and FDA inspects to confirm compliance with the law. The consent decree also requires defendants to destroy any remaining drugs that they recalled in April-July 2008, that are currently in their possession.
FDA advised patients who have been using Actavis products to discuss alternative therapies with their healthcare provider. Pharmacists should discontinue dispensing all unapproved drugs manufactured by Actavis Totowa, the agency added.
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.
Actavis Totowa manufactures, processes, packages, labels, holds, and distributes drugs from two sites in Totowa, N.J., and one in Little Falls, N.J. FDA inspected Actavis Totowa’s Riverview Drive facility in Totowa from March-May 2008, and found that the company had significant cGMP violations and continued to manufacture unapproved drugs. As a result of this inspection, Actavis Totowa recalled all products manufactured and distributed from its three facilities. Actavis Totowa is a wholly owned subsidiary of Actavis, the manufacturing and marketing arm of Actavis Group, a generic pharmaceutical company based in Reykjavik, Iceland.
“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.”
Liquidia partners with Abbott on genetic disease treatment research
RESEARCH TRIANGLE PARK, N.C. A pharmaceutical company and a nanotechnology company will collaborate to develop particles to deliver short interfering RNA particle therapeutics.
Liquidia Technologies and Abbott announced the collaboration Wednesday, in which they will use Liquidia’s PRINT technology to fabricate nanoparticles of precise shape, size and chemistry to shut off genes associated with certain diseases.
“Delivery has been the most significant hurdle to realizing the broad potential of siRNA therapeutics,” Liquidia CEO Neal Fowler said in a statement. “We are very pleased to form a partnership with Abbott, which we hope will enable significant progress in addressing this problem.”
Under the agreement, Liquidia will provide Abbott with certain rights to PRINT technology for developing and commercializing siRNA therapeutics. The two companies did not disclose financial terms.
PhRMA, health organizations release video ad pushing healthcare reform
WASHINGTON Six organizations representing a broad portion of the U.S. healthcare industry unveiled an advertisement Thursday to promote healthcare reform as a top priority for the incoming Obama Administration and the next Congress.
The Pharmaceutical Research and Manufacturers of America, Regence BlueCross BlueShield, the American Medical Association, the Service Employees International Union, the American Cancer Society Cancer Action Network and Families USA showed the 30-second ad at a press conference at the American Medical Association’s headquarters in Washington Thursday.
The ad focuses on the country’s manufacturing industries, opening with shots of decrepit factories and cobwebbed equipment, followed by shots of working factories with employees. It opens with the line, “At a time when American businesses are hurting, why should we worry about fixing health care? Because quality, affordable health care can save money and make businesses more competitive.”
The organizations plant to run the ad until Feb. 5, possibly later.
“Expanding access to quality and affordable health insurance is good for patients and good for our economy,” PhRMA president and CEO Billy Tauzin said in a statement released with the ad. “Improved access means we can do more to promote prevention and more to detect and treat conditions at an early stage, when we can do the most to avoid poor health outcomes and costly complications of chronic diseases, which account for seven out of every 10 deaths in America.”