OP-EDS

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January 31, 2005

The FDA: profit-seeking or profitless?

In 1906, Upton Sinclair wrote The Jungle, the Food and Drug Act was passed, and the Food and Drug Administration (FDA) was born. Founded on the premise that consumers can't distinguish between a bottle of cough medicine and poison—or between a scientific drug study and an advertisement for a miracle cure—the FDA was meant to protect the American public against "the profit motive." Now, a century later, the media has begun a new mud-slinging campaign. This time it is not against companies, but against the FDA.

A CNN.com article offers a carefully worded implication that the FDA is receiving kickbacks from major drug companies. The article complains, "The agency also receives hundreds of millions of dollars from the drug companies, which pay huge fees to have new drugs expediently reviewed and approved. Most people agree that relationship is all too comfortable." If the media were going to attack the FDA, this is precisely the sort of attack one might expect. It's exactly the same profit-motive accusation that got the FDA established in the first place: If an entity—be it an individual, a corporation, or a government agency—is motivated by money, it must be corrupt. What's surprising is that the media is attacking the FDA at all. Isn't the FDA our protection against profit-seeking drug companies? The industry is regulated. Aren't we safe now?

Apparently not. The FDA, it seems, is no more immune to errors of judgement than drug companies are. In December, The New York Times reported on a defective line of FDA-approved defibrillators. Earlier in the year a scandal involving Merck's popular drug, Vioxx, shook the newspapers and inspired the current wave of anti-FDA sentiment. Senator Chuck Grassley of Iowa, leading that wave, states the problem succinctly: "The American people should be the number one and only client of the FDA." It couldn't be more true—but not in the way Grassley intends it.

The problem is not that the FDA is receiving kickbacks from drug companies. First of all, it isn't. Drug companies are forced, by a law called PDUFA, to pay the "huge fees" CNN talks about—not for having their drugs approved, but for having them reviewed at all. Second, because Grassley is right. The American public is not a client of the FDA. The FDA, in fact, does not have any clients. It does not engage in voluntary trade. The FDA is not a corporation with clients who will forsake it if it creates a bad product or sue if it perpetrates a fraud. It is a list of regulations enshrined in a government office. It creates no product, it has no clients, and it is accountable to no one.

In other words, the FDA has no vested interest in keeping harmful drugs off the market. If it slips up, it will weather a media storm. It has been weathering such storms since 1906. The PDUFA law won't change; the FDA will continue to receive its million dollar fees. It is drug companies who really stand to suffer from selling harmful drugs—precisely because drug companies are actually motivated by profit. The same CNN article that lambasts the FDA reports that "Merck's legal costs in the wake of the Vioxx fallout could reach $12 billion, and the company's liability could total $18 billion." And that's just for a painkiller that might or might not create a higher risk of heart disease. Drug companies can't get $1 billion—much less $12 billion—by taxing the American public; they can only get it by selling a product that people want to buy. It is drug companies that are motivated by profit; it is drug companies that truly care about keeping bad drugs off the market.

The media's proposed solution to the FDA problem is to create "an independent drug safety board" to review the decisions of the FDA. Thirty years down the line, when the next Vioxx scandal hits, who will review the reviews of the Independent Drug Safety Board that allowed the FDA to allow the drug to hit the market?

The answer is not a new level of disinterested review. The answer is to recognize that interest, i.e. profit, is the best safeguard against harmful drugs. The answer is to place sole responsibility for drug safety on the entities that have earned it, and stand to lose the most from shirking it: drug companies.