Security of imported drugs is lagging, deserves attention
Few give it a second thought — you see your doctor and pick up a prescription, often a generic version of a name-brand drug. There’s comfort in knowing the federal Food and Drug Administration is there to oversee pharmaceutical manufacturing.
Earlier this month, though, F.D.A. inspections of drug-making factories in India resulted in a ban on importation of three popular generic medicines. The more that’s learned about the realities and risks of drug manufacturing, the more concerns grow.
In today’s global economy, products are made all over the world and many, or most, items found in American stores come from overseas. But while people are used to wearing clothes made in China, Indonesia or Bangladesh, it’s another thing when it comes to medicines we put in our bodies or need to stay alive.
The recent F.D.A. action has prompted news stories that are real eye-openers for most Americans. It’s something of a shock to learn that 80 percent of the prescription drugs Americans take originate in China or India. Beyond that, the unease grows with reports that F.D.A. inspections have only begun to examine the safety of drugs coming from overseas.
A 2012 law passed by Congress mandated more inspections of overseas drug manufacturing facilities and funded the extra staffing with a fee on generic drug sales. Last year, F.D.A. inspectors checked 160 Indian drug plants — three times the inspections in 2009. The stepped up inspections revealed some troubling conditions. The inspections found some Indian drug plants are top-quality, but revealed others are not. Inspections found unhealthy conditions in some factories and also evidence of adulterated drugs, which led to the ban on generic versions of the acne drug Accutane, the antibiotic Cipro and the pain drug Neurontin.
Today’s global economy presents serious challenges to federal regulators, given that the vast majority of drugs sold here come from overseas. It’s also worth remembering that 80 percent of the seafood consumed in the U.S. is imported as is about 50 percent of our fresh fruit. More inspections are essential, but only a small percentage can be checked and risks will remain.
It’s one thing to understand that nearly all computers, televisions and children’s toys are made in China or other countries. But these are not products we consume or take to maintain our health. With the majority of all drugs having foreign origins, and inspections only ramping up now, health experts’ concerns are real — and should be better understood by the public.
Life-saving antibiotics and steroid medicines administered in U.S. hospitals every day all come from overseas factories. The last U.S. antibiotic manufacturing facility, located in Syracuse, N.Y., was closed in 2004.
Some heatlh experts view this reliance on factories in China and India as a national security issue, suggesting the U.S. healthcare industry would be in chaos if a political or military dispute resulted in the supply of these critical drugs being cut off.
While it’s encouraging to see the F.D.A. doing more inspections of overseas manufacturers, the news is not all good. In addition to troubling conditions and adulterated drugs being found in some Indian factories, the expanded inspection effort in China has not even begun. Two years ago, the F.D.A., needing to add to staff in China for more inspections of drugs being brought into the United States, requested the necessary visas. But the agency’s requests for visas for inspectors has so far been rejected by the Chinese government.
It’s unclear how long the expanded efforts by the F.D.A. will need to be in place before Americans — patients and doctors — can be more confident in the quality of many of the lifesaving medicines on which we depend. Congress and President Obama should be addressing this issue publicly, despite the doubts and fears it raises about the federal government’s effectiveness in keeping Americans safe.
