In its effort to bring more competition and lower prices to the prescription drug market, the Food and Drug Administration approved 763 generics, a record, in fiscal 2017, and it expects to top that number this year. “But getting more low-cost medicines to pharmacy shelves could strain a global supply chain already confronting questions about quality and safety -- especially in India, where about 40 percent of generic drugs taken by Americans are made,” Bloomberg’s Anna Edney reports.
FDA staffing shortages and efforts by drug company workers to evade or mislead regulators have resulted in “oversight gaps” that could get worse.
FDA inspections of the more than 500 facilities in India registered to manufacture drugs for the U.S. dropped 27 percent in fiscal 2017.And the inspection reports that were produced “read like mystery novels full of deleted data, shredded documents and evasive employees,” Edney writes.
Read the full story here for more disturbing details.