OP-ED ON THE NEW YORK TIMES:
A flood of fraudulent medicines sold mostly in the developing world is threatening the health of hundreds of thousands, if not millions, of people in those nations and consumers in more advanced nations as well.
International organizations, national drug regulators and the drug industry itself have been struggling for years to curb sales of phony or poorly prepared medicines. But articles in a special issue of the American Journal of Tropical Medicine and Hygiene, published online last month, show that efforts to control this problem have had only modest success over the past decade.
The number of outright fakes — pills containing no active ingredients at all — may have declined. However, the problem of substandard medicines that have some, but not all, of the active ingredient they are supposed to contain has worsened. Sometimes a medicine degrades because it has not been stored or handled properly. But often the manufacturer deliberately reduces the amount of active ingredients to save money while increasing inert ingredients to keep the weight and shape the same.
HHS OIG confirms better FDA inspection performance for generics manufacturers
May 08, 2015
But is bioavailability sufficiently monitored by FDA for generic products on the market?
Dating back to the FDA Safety and Administration Act of 2012 (FDASIA), Congress had taken a more critical look at FDA inspection practices generally, and the specific problem of fewer inspections of manufacturing sites outside the US than inside it. A 2010 GAO report had found that 40% of domestic manufacturers had been inspected, but only 11% had been during 2007-2009 (not all manufacturers have to inspected all the time; and since then FDA has instituted a risk-based evaluation process to target certain sites). Now, HHS’ Office of Inspector General has found that FDA is getting closer to parity in US/non-US “surveillance” (routine) inspections; in FY2013, 57% of inspections were of non-US facilities. However, the parity based on risk evaluation is still to be met, as well as comparable “depth and rigor” of the inspections.