Ben Venue Reaches Agreement with FDA

February 1, 2013

913181_long_corridor_in_a_factory.jpgBen Venue Laboratories and the FDA entered into a consent decree that will allow the company to manufacture Doxil, a chemotherapy drug in dangerously short supply. The company voluntarily shut down in 2011 due to quality and manufacturing concerns.

Ben Venue is a sterile injectable drug product manufacturer based in Bedford, Ohio and owned by Boehringer Ingelheim. The voluntary shut down was the direct result of numerous FDA and European Medicines Agency violations. Before the 2011 shutdown, Ben Venue was the world's exclusive Doxil supplier. Doxil is an injectable chemotherapy drug by Johnson & Johnson for patients with complex or recurring ovarian cancer, AIDS-induced sarcoma, and multiple myeloma. After the shut down, the FDA attempted to import the chemotherapy drug from India, however, the demand was fast outpacing the supply, and a critical shortage loomed. In mid-2011, Johnson & Johnson was forced to start placing patients on a waiting list for the drug. Dangerously ill patients were forced to defer the treatment or use other, less effective, therapies.

Since 2002, Ben Venue has been subject to nearly 40 drug recalls, nine of which were due to serious negative health effects and risk of death. In 2010, the FDA inspected Ben Venue and found that a leaky roof was contaminating the facility. This contamination resulted in two products infected with stainless steel, mold in manufacturing areas, rusty equipment, and bacterial infections in some batches of other drugs. Other quality issues included glass contamination and the discovery of a ten-gallon bucket later determined to be filled with urine.

The consent decree, which is subject to approval by U.S. District Judge Lesley Wells, requires Ben Venue to take numerous actions to correct its citations and make sure they will not occur again. The company will also be able to manufacture and distribute more than 100 drugs going through a shortage, if the decree is approved. Before each batch will be allowed to distribute, however, an independent expert must review and certify that the drug was manufactured under all proper standards. This expert will inspect and approve Ben Venue's facilities and quality control plan before any manufacturing may take place.

In addition to the 40 recalls, Ben Venue was subject to about 35 FDA inspections since 1997. The U.S. District Court accused the company of violating the Food, Drug, and Cosmetic Act by initiating contaminated drugs into interstate markets. Ben Venue neither admitted nor denied the federal allegations.

Under the consent decree, Ben Venue will be able to continue drug development and may file applications for generic drug manufacturing. If the company's remedial efforts progress to the FDA's satisfaction, Ben Venue will receive approval to manufacture the generic drugs, among other products. The company has currently invested more than $300 million to upgrade its facilities and remedy the manufacturing and quality issues.

Johnson & Johnson has already cleared the patient waiting list for Doxil and began to replenish the supply, but the damage caused by shortages of vital medications such as Doxil is yet to be disclosed. One joint inspection by UK, French, and US officials in late 2011 resulted in the recall of Busilvex, Velcade, and Vidaza, which are three oncology drugs. The European Medicines Agency also recalled certain batches of an anti-fungal medicine and a diagnostic agent. Phamaceutical companies such as Pfizer have developed exit strategies for its products manufactured at Ben Venue.

Drug recall attorneys at Pintas & Mullins hope that the quality and manufacturing concerns at Ben Venue are remedied quickly. The drugs manufactured at the Ohio plant are of critical importance to patients with cancer and other life-threatening illnesses, and must be manufactured in accordance with all federal standards. If you or someone you love was seriously injured by a dangerous prescription drug, you may be entitled to compensation and should seek legal guidance.