Many drugmakers had supplies interrupted when Boehringer Ingelheim closed its Bedford, OH plant in 2011 because of serious quality issues, but it was a shortage of Johnson & Johnson's ($JNJ) ovarian cancer drug Doxil that grabbed public attention. Because the facility was the sole supplier of Doxil, J&J and the FDA started jumping through hoops to get supplies of the essential treatment to patients when the problems hit. Now J&J wants something from Boehringer as compensation.
J&J has sued a unit of Boehringer, Bloomberg reports, saying the company breached its 2009 agreement with J&J to make Doxil. "BI's breach of the agreement cannot be seriously disputed," J&J said in the lawsuit, according to Bloomberg, which was unable to get a comment from Boehringer.
The action is trying to force Boehringer into arbitration over the debacle. The interruption cost J&J sales and added to expenses as it scrambled to find ways to supply the drug whose popularity remains high despite generics in the market. "Although sales of most brand drugs rapidly diminish when a generic version is introduced, utilization of Doxil has remained high," the suit reads.
Manufacturing and sterility problems at Ben Venue Laboratories, the unit of Boehringer Ingelheim that makes Doxil, forced the contractor to suspend operations in November 2011 and later to sign a consent decree with the FDA. By February 2012, FDA Commissioner Margaret Hamburg had turned to India's Sun Pharma to import Lipodox, a Doxil substitute that the FDA had not approved. The company manufactured the injection at an FDA-approved facility in India. Earlier this year, the FDA approved a generic version of Sun's drug for the U.S. market to help ease the shortage. J&J also started looking for an alternate supplier but devised a multi-step process in which Boehringer did some of the production, but the drug was finished at another facility. The steps paid off and shortages abated.
The drug shortages caused by the production interruptions at Ben Venue caught the attention of the public and lead some in Congress to criticize the FDA for being too aggressive with its enforcement actions. The FDA countered by saying that poor-quality manufacturing puts patients at risk. The agency has gotten more proactive in helping companies and patients find alternatives when drug shortages appear imminent. In fact, the consent decree Ben Venue signed in January was uncharacteristic. It barred the plant from manufacturing some drugs until upgrades are made, but it also allowed the company to continue to produce 100 drugs during remediation because they were considered "essential for patient care."
- read the Bloomberg story