This week consumer-product regulation has been on lawmakers’ minds. The Senate Commerce Committee approved on Tuesday the Consumer Product Safety Commission (CPSC) Reform Act of 2007 that would expand the CPSC’s authority and increase its budget and staff. On Thursday, the House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing on FDA’s Foreign Drug Inspection Program, putting Commissioner Andrew C. von Eschenbach in the hot seat over his agency’s inadequate inspection of foreign drug manufacturers.
All this Hill activity is certainly appropriate: consumer anxiety about the safety of the products we buy every day remains high and mainstream media reports about new potential dangers posed by Chinese-made products keep coming.
We’ve already highlighted the New York Times story this week that exposed the frightening reality of the Chinese pharmaceutical market. What does it mean for the American consumer? Over the last six years, manufacturing of active pharmaceutical ingredients (AIPs) has been increasingly moving to China and India, to the point that now, approximately 80 percent of the active pharmaceutical ingredients that go into the finished medicines Americans will consume are manufactured abroad, mostly in those two countries.

Neither China nor India has the same regulatory standards as the U.S. and the European Union. Moreover, U.S. regulators are not able to carry out the same degree of oversight at foreign production facilities as they do at home. By law, FDA has to inspect domestic drug manufacturers at least every 2 years. However, of the 700 FDA-registered firms in China, the agency was able to carry out inspections at only 17 last year.
Even more alarmingly, firms that are not registered with the FDA, such as Chinese chemical companies that are making pharmaceutical ingredients illegally, never get inspected. According to the Times, China has an estimated 80,000 chemical companies, but our FDA does not know how many sell ingredients used in drugs consumed by Americans.
The pharmaceutical industry stresses that there is a duality to the regulatory system: government oversight on the one side and the company’s own quality control on the other. Yes, the pharmaceutical companies try to ensure that their supply chains are not compromised, but how successful can they be when even the local authorities in countries like China have no idea who is producing what components for the medicines that end up on the world market?
The U.S. has a state-of-the-art regulatory system, but even our system has gaps. When manufacturing shifts to developing countries, the high quality and safety standards that the American consumers have come to expect from products made in America can no longer be guaranteed, as we have seen time and time again. When production shifts abroad, the costs of production may decrease, but society’s costs rise, whether to pay for better regulation, or to deal with the consequences of consumer exposure to inferior, or dangerous products.
We’ve already seen recalls of toys, pet food, toothpaste, and many other goods, that may be dangerous to consumers. If more medicines are imported from China, the health and lives of our most vulnerable citizens may be put at risk.
There’s no question that production quality, inspections, and the level of regulation need to be dramatically enhanced. But the only way to guarantee the highest possible quality standard for our pharmaceuticals is to manufacture more of them in the U.S. under our close scrutiny, rather than trust others to take the matter of consumer safety to heart.
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