Low Generic Profit Margins May Cause Drug Shortages, GAO, HHS Say

Despite FDA prioritizing review of generic drug and supplement applications for sterile injectable drugs, shortages are ongoing due to a decline in the number of suppliers, agency warning letters that lead to supply disruptions and low profit margins for generic drugs, the Government Accountability Office said in a report. HHS agreed with Congress' investigative arm that there may be a link between low-profit margins and product access, but defended its inspection process as a public health necessity. HHS also stressed...