Troubled US pharmaceutical major Schering-Plough has reached an agreement with the US Food and Drug Administration to correct the firm's manufacturing compliance problems, which led to a $500 million fine last year.
S-P's failure to meet current Good Manufacturing Practice standards at its facilities in Kenilworth and Union, New Jersey, and Manati and Las Piedras in Puerto Rico led to significant delays in bringing some of its pipeline drugs to market, notably the new-generation antihistamine Clarinex (desloratadine). The company now says that the FDA has agreed with a two-year plan to bring the four facilities up to the required standard.
FDA inspectors said that S-P's facilities had failed on a number of counts, including manufacturing, quality assurance, equipment, laboratories and packaging and labelling.
In the meantime, the company is facing criminal charges in the US over charges alleging that it has illegally promoted some of its medicines for off-label uses and providing inducements to doctors and managed care organizations in return for prescribing its drugs.