The Food and Drug Administration, created in 1906, has been one of the most successful regulators in history—carrying out the monumentally complicated task of keeping America’s pantries and medicine cabinets free of harmful products even as the food and drug businesses have grown exponentially more complex. But as the drug business in particular has gone global in the past few decades, the FDA’s job has moved from extremely difficult to well-nigh impossible. Unless, of course, it can make some radical changes.
The drug business has been an international market for a very long time. Until recently, this has just meant that many of the most familiar drugs in your pharmacy have come from France or Switzerland—countries whose regulators work closely with the FDA. No one really worries about the quality of imported Canadian or European drugs, and the FDA is well positioned to inspect and certify those drugs.
But as the Washington Post reported on Sunday, the Euro-American character of the drug industry is rapidly changing. India has become a major pharmaceutical power, and China is increasingly a source of ingredients and chemicals used by drug companies worldwide. As the Post notes:
In 1999, India did not appear on an FDA chart of master files [applications to sell pharmaceutical ingredients in the U.S.]. By 2004, almost half of the reviewed files for drug ingredients destined for U.S. patients came from Indian companies. More recently, Indian companies have moved more aggressively into making finished drugs, and Chinese companies—which expect as many as 4,000 international buyers at a series of drug ingredient conferences in Shanghai this month—have expanded their share of the market in active ingredients.
The FDA is supposed to inspect foreign sites that produce significant amounts of food or drugs sold in America. But there are very few inspectors in India and China, and for the most part the FDA relies on each nation’s internal quality control measures.
So far, there has not been a major safety scare with drugs from India or China; these problems, for the moment, lie under our consumer radar. But given long enough our luck will run out. The pet food scandal earlier this year, which involved ingredients from China, offered a tiny hint of what a major international drug scare would look like. It would reveal the thin strands of our drug safety net, and the extremes to which the FDA is now being stretched.
The drug industry looks nothing like it did in the year of the FDA’s birth. The time has come for the agency to change as well. It is simultaneously too stringent in reviewing domestic drug development and too lax in assuring the basic safety of drugs and ingredients imported from abroad. The former problem could be addressed by a greater focus on the post-approval testing of new drugs, while the latter would benefit from much more oversight of the countries that are becoming the main suppliers of our drugs and drug ingredients. The agency needs to return to its founding mission as a guarantor of essential safety and efficacy, which means doing both far more and far less than it does now.