FDA launches project to cut quality control lapses at drugmakers
On January 12, the FDA launched its Office of Pharmaceutical Quality, in order to establish consistent quality standards for all drugs and to cut quality control lapses at pharmaceutical manufacturing facilities.
Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research, will oversee the office until a director is found. The FDA plans to propose a set of quality metrics for drugmakers. Afterwards, a public comment period will take place, and the FDA will produce a final rule.
Between 2013 and 2014, the number of drug recalls fell by 20 percent, according to Todd Harris, VP of Recalls at Stericycle Inc. Woodcock claims that, up until now, the FDA has only had a general sense of the state of manufacturing quality. Now, the FDA will have quantitative information.
