FDA's Jensen Says Drug Shortages Largely Result Of "Quality Issues"

submitted by Luis Kun

HealthDay (10/3, Gardner) reports, "Prescription drug shortages in the United States, which reached a record high last year, are getting worse, the US Food and Drug Administration said Friday." Valerie Jensen, associate director for the Drug Shortage Program within FDA's Center for Drug Evaluation and Research, said that "so far this year, some 200 drug shortages have occurred compared to 178 in all of 2010." Jensen added that "many of the scarce drugs are injectables...used to treat serious conditions such as cancer. Some are only given in hospitals and are 'absolutely critical.'" Causes listed for the shortages include "quality issues, such as sterility or drug impurities," "delays or manufacturing capacity problems," "discontinuation" and "raw material shortages." The first is the largest cause by far responsible for over half of the shortages.

        Medscape (10/3, Lowes) also reports on Jensen's Webinar explaining that "in 2010, sterile injectables constituted 74% of the 178 drugs deemed to be in short supply by the FDA," and "product quality and manufacturing issues such as glass and metal particulates, impurities, and bacterial and mold contamination accounted for 54% of sterile injectables in short supply." She added, "There's not enough backup capacity." Jensen said, "We can't tell a manufacturer how much to produce," but the FDA "can expedite review of new manufacturing sites, new suppliers of raw materials, or changes in specifications," and "has helped some companies salvage injectables containing particulates by letting them be distributed with filters."

        WebMD (10/3, Rubin) reports that Jensen said that "only seven companies produce most sterile injectables."

        Drugmakers Cite Raw Material Shortages, Communications, And Regulations. American Medical News (10/3, Trapp) reports on drug shortages with a focus on the September 23 hearing before the House Energy and Commerce health subcommittee. The story notes that "fewer than 10% of drug shortages are due to a shortage of raw materials." Teva Health Systems executive Jonathan Kafer is cited saying that "FDA has needed up to three years to approve an alternative source for active ingredients or to approve a new manufacturing site or method." Generic Pharmaceutical Assocation President and CEO Ralph G. Neas blamed "insufficient supplies of raw materials to meet demand, delayed communications about shortages, and changes in clinical practices that have altered production volume." Rear Adm. Sandra Kweder, MD, deputy director of the Office of New Drugs at the FDA's Center for Drug Evaluation & Research, is cited saying that "in most cases, manufacturers knew about drug shortages in advance but did not notify the FDA."