Troubled Boehringer Ingelheim Corporation Unit Gets a Consent Decree

Two years after quality-control problems caused severe shortages of several medicines and later prompted manufacturing to be suspended at a troubled facility in Ohio, Ben Venue Laboratories has entered into a consent decree with the FDA. Among the many drugs for which shortages were caused by the difficulties was the Doxil cancer medication sold by Johnson & Johnson. Under the terms of the decree, the Boehringer Ingelheim unit cannot make or sell certain drugs, but there are exceptions. Ben Venue can continue manufacturing and distributing more than 100 drugs deemed “essential for patient care,” as well as continue drug-development activities. The drugmaker may also file abbreviated new drug applications and, possibly, win ANDA approvals, according to a company statement and court documents. The Bedford, Ohio, facility has had a very troubled record. The FDA found 10 violations of good manufacturing practices during a late 2011 inspection and 48 violations in May 2011. In fact, the agency conducted 35 inspections since 2007 and Ben Venue initiated some 40 recalls since February 2002, including nine considered to be Class I, which is the most serious type of recall because it can lead to potential harm, according to court documents (here is the government lawsuit and the consent decree). Despite dozens of inspections, a warning letter and numerous conferences, Ben Venue repeatedly failed to comply with manufacturing regulations, the government lawsuit notes. The drugmaker, however, tried to avoid letting its failings become public. When we first reported the many difficulties in 2011, Ben Venue publicly blamed capacity constraints and did not acknowledge ongoing quality control problems.