FDA Admits Failing To Inspect China Supplier

Today's leap year surprise is the prominent front page article in The New York Times proclaiming "A Blood Thinner Might Be Linked To More Deaths." The article is a surprise because the FDA has been underfunded and undercommitted with respect to inspections of drug manufacturers and suppliers outside the United States for years, and the Times just got around to noticing it.

Several years ago I (and several others) met for breakfast with the then Director of the FDA who told us pointedly that the FDA was incapable of inspecting pharmaceutical manufacturing facilities outside the United States because there was no political will to do so (as demonstrated by failure of several administrations to propose such inspections)and Congress neither demanded nor budgeted the FDA to conduct such inspections. The FDA had difficulty in obtaining funding for its mandates in the United States and was incapable of taking on a sophisticated international role.

Folks, there aren't earmarks for FDA international pharmaceutical quality, safety and effectiveness inspections. Without money, staff, training and commitment, the FDA is incapable of safeguarding our pharmaceutical supply. The next time your Congressperson offers to build a new road for your community, why not ask for a safe traceable medication supply policed by a well-funded and competent FDA instead?