The FDA: Corporate Stooge or Coercive Stodge?

In 1906, Upton Sinclair wrote The Jungle, the Food and Drug Act was passed, and the 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 Food and Drug Administration 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 article offers a carefully worded insinuation 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 unexpected 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 judgment 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, leapt to the headlines and inspired the current wave of anti-FDA sentiment. Senator 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 Senator 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 the Prescription Drug User Fee Act (PDUFA), to pay the “huge fees” CNN talks about–not for having their drugs approved, but for having them reviewed at all. Second, because Senator Grassley is right. The American public is not the one and only client of the FDA. The FDA, in fact, could not have any clients: it does not engage in voluntary trade. The FDA is not offering a product to clients who will forsake it if it offers nothing of value, or sue if it perpetrates a fraud; it is accountable to no one. It does not sustain itself as a productive enterprise, but by government decree.

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 distrust of the people who are meant to benefit by it does not matter–the FDA’s existence does not depend on those people’s choice. It is drug companies who really stand to suffer from selling harmful drugs–precisely because drug companies are actually motivated by profit. Drug companies, in a free market, stand or fall based on the voluntary actions of consumers. A company’s profit is the measure of the extent to which people choose to trade with it. The FDA do not work to create a product that consumers see the value of and therefore purchase. No individual chooses to trade with the FDA. The public is forced to accept their reviews–irrespective of whether they judge them to be even honest, let alone correct.

The same CNN article that lambastes 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 a billion dollars–much less 12 billion–by taxing the American public. They can only get it by creating 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.

Were the FDA disbanded, however, it would not be merely the fear of lawsuits that would motivate drug companies to offer effective and safe drugs. It would be–surprise–the profit motive. How priceless would a reputation for impeccable caution be in a free market drug company? How much more care a company would take to insure drug safety knowing that a lawsuit would destroy its credibility, not that of the eradicable FDA? How effectively would private review boards, like those that exist for cars and appliances, publish studies by which the consumer could easily educate and inform himself? How willingly would a drug company spend billions on R&D for a cure for cancer or Alzheimer’s, if it had to rely only on the freedom and independent judgment of the consumer to ensure a fair return?

The media’s proposed solution to the FDA problem is to create “an independent drug safety board” to review the decisions of the FDA. But 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 private sector, to allow whatever corporation is up to the task of production to stand or fall based on the quality of its products.

Rebecca Knapp is a junior at the University of Chicago. She is studying classics and plans to go to law school.

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