Today’s Wall St. Journal describes how quality control problems in pharmaceutical manufacturing plants are causing shortages of critical medicines, including methotrexate, which is used to treat leukemia in children.
For those of us working in the industry, it’s not surprising news. During the 1990s, the pharmaceutical industry focused on marketing and to a lesser extent R&D. Manufacturing was neglected. According to the Pharmaceutical Research and Manufacturers Association of America (PhRMA), from 1990 to 2000 marketing employment grew 57%, R&D 11%, and production/quality control shrank by 1%.
Regulatory agencies are none too happy about the situation, and have been moving more aggressively to cite offending plants and even seize products. The FDA’s Dr. Janet Woodcock has called manufacturing, “the poor stepchild” of the pharmaceutical industry and it’s easy to see why.