There is a pattern shaping up - the FDA scrambles to hold a briefing on the latest twist in the Heparin investigation, and Congress raises the stakes by firing off more letters. Now, though, the House Energy and Commerce subcommittee on Oversight and Investigation will hold an April 28 hearing to learn more about how a contaminated batch of the Heparin blood thinner made its way from China to the US. Of course, we know one reason - the FDA failed to inspect the plant due a paperwork mix-up.
Earlier today, the FDA acknowledged that a chemically altered substance called over-sulfated chondroitin sulfate is probably the contaminant that the FDA believes is linked to nearly 800 serious adverse events and 19 deaths. “FDA’s recent finding on the heparin-like contaminant only heightens my suspicions about deliberate illegal conduct and reinforces my concerns about the need for closely examining Chinese manufacturers that ship FDA-regulated products to the United States,” Joe Barton, a Texas Republican and rRanking member of the House committee, says in a statement.
The subcommittee also plans a hearing on April 22, to ask FDA commish Andy von Eschenbach to explain the agency's efforts to inspect foreign plants making ingredients and drugs for the US market.
"The FDA should establish a schedule by which all Chinese firms exporting to the US that haven't been inspected in the past three years re-inspected in the next three," says Michigan Democrat Bart Stupak, who chairs the subcommittee. Andy "should be prepared to submit such a plan to Congress to assure the American public that steps are being taken to ensure the safety of food and drug imports. The sad reality is that FDA’s inability to inspect foreign facilities has put American lives at risk."