When Leavitt was secretary of health and human services, he oversaw the worst imported-drug problem in recent years. The moderately strict medicine screening in place in 2007 failed to spot contaminated Heparin that killed 149 Americans. Luckily, the companies involved quickly identified the problem.
Of course inspections are important, and they catch some problems. But simply demanding FDA inspections and more paperwork, as much pending congressional legislation does, would increase costs, slow imports, and find only the most obvious problems.
As health-care costs rise, some manufacturers are probably cutting corners in their chemical procurement to remain competitive. The cutthroat pricing of generics means this problem probably affects generics more than brand-name drugs.
The only long-run solution is for our chemical sources, notably those in China, to improve their practices. And we can and should help. We can help educate and work more effectively with our Chinese partners to inculcate better systems and less corner cutting. Private industry and the U.S. Commerce Department are involved in programs to do so already.
The first step to prevent quality problems is for the industry to certify each step of production. The Western industry-led initiative RX-360 is attempting to overhaul outdated practices and improve all forms of surveillance and cooperation. Chinese companies make the cheapest chemicals in the world, but some are undoubtedly substandard.
Knowing where all our ingredients come from is the first step toward improving drug quality. Simply complaining about Chinese plants or demanding more FDA visits will not fix the problem.