September 26, 2007
Pharmaceutical Costs

The NYTimes reports that WalMart and increased acceptance of generic drugs have slowed the rate of inflation for pharmaceuticals:

As overall health care costs continue to rise sharply, prescription drugs have emerged as a surprising exception.

Economists say the slowdown has come about because more people are turning to generics and because generic versions of some of the most common drugs have recently come on the market.

Another factor could be the so-called Wal-Mart effect. Last fall, Wal-Mart began offering many generic prescriptions at $4 a month. Target quickly announced a similar plan, and Kmart expanded its program, which offers a 90-day supply of generic drugs for $15. Other retailers have followed with their variations. Publix, a grocery store chain with 684 pharmacies in five states in the Southeast, announced last month that it would not charge for prescriptions for seven commonly used antibiotics.

Now, if only producers of legacy drugs were allowed to add to this pressure. But, as the Wall Street Journal reports, the FDA is moving in the opposite direction:

In a little-noticed program announced last June, the Food and Drug Administration is cracking down on remedies like quinine. These belong to a class known colloquially as legacy drugs: That is, they are generally recognized as safe and effective, and have been prescribed by physicians for decades, in some cases before the modern FDA regime was created in 1962. But since they lack a formal FDA stamp of approval, they're being yanked from the market.

In a more rational political world, legacy drugs might be "grandfathered in," since the risks they pose are so few. The FDA, however, remains under intense scrutiny for handling of pharmaceutical safety in the aftermath of the Vioxx furor. So the agency is pulling out all the bureaucratic stops to mollify its Capitol Hill critics like Pete Stark and Chuck Grassley.

Legacy drugs form about 2% of the total pharmaceutical market, and they're generally prescribed not to cure illness but to relieve symptoms -- cough, cold and allergy, as well as other specialty medications. They're manufactured by several hundred small- and medium-sized companies; the active ingredients and compounds are approved by the FDA and the drugs are synthesized in FDA-licensed facilities.

Legacy drugs, then, aren't medical moonshine cooked up in somebody's bathtub; nor are they new or experimental drugs. Nonetheless, the FDA is requiring them to be put through the same regulatory wringer. Some must complete a New Drug Application, which requires clinical trials and can cost between $5 million and $10 million per legacy drug.

Posted by Wilson Mixon at 03:45 PM in Economics

The statesman who should attempt to direct private people in what manner they ought to employ their capitals would not only load himself with a most unnecessary attention, but assume an authority which could safely be trusted, not only to no single person, but to no council or senate whatever, and which would nowhere be so dangerous as in the hands of a man who had folly and presumption enough to fancy himself fit to exercise it. -Adam Smith

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