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Keep Your Laws Off My Meds! August 25, 2006

Posted by federalist in Healthcare, Regulation.

More evidence that prescription drug regulation is more about politics than consumer protection:

Plan B consists of two pills taken 12 hours apart within three to five days of sexual intercourse. The dosage of contraceptive drug in these pills is 12 to 15 times that of a regular contraceptive pill. Remember: Plan B is now cleared to be sold OTC, yet the lower-dose conventional Pill still requires a prescription. Odd. Never before has a higher dose of a particular drug been made available OTC while a lower-dose preparation still requires a prescription.

The contrast is, as Homer Simpson might say, “Ovuliscious.”

Why not just get government out of our medicine cabinet, and let adults buy whatever pharmaceuticals they want?


1. federalist - June 15, 2007

David Henderson and Charles Hooper offer compelling arguments in their May 17 WSJ essay, “Our Lawless FDA”:

The Food and Drug Administration spends your money and acts in your name to regulate medicines. It has been acting badly.

The FDA is supposed to judge whether a drug is safe and efficacious and that’s all. In its literature, the FDA even agrees with this role, saying that, “Once a new drug application is filed, an FDA review team — medical doctors, chemists, statisticians, microbiologists, pharmacologists, and other experts — evaluates whether the studies the sponsor submitted show that the drug is safe and effective for its proposed use.” But the FDA slyly added a third requirement: Is Arcoxia [the latest reject] better than what’s currently on the market?

The fact that we’re talking about drugs often causes us to forget what we know about other products whose safety and efficacy are important. We shouldn’t. Imagine that Saturn had to prove that its new car, Aura, is safe, works well, and is better than Accord and Camry before a single Aura hits the showroom floor. If the evidence is too costly for Saturn to collect, Aura will be rejected regardless of the facts. To prove superiority, what manner of tests would Saturn run? How much would this cost and how long would it take? What if five years later Saturn presented its evidence and, on some attributes Aura was better, on some it was equal, and on some it was worse than Accord and Camry? Is it a better car?

There’s no right answer.

The FDA knows that it can make two types of errors. If it approves a drug later found to be dangerous, bad things happen. As one former FDA employee, Hoover Institution’s Henry Miller, put it, “This kind of mistake is highly visible and has immediate consequences — the media pounces, the public denounces and Congress pronounces.” If the FDA fails to approve a good drug, few bad things happen — to the FDA.

Americans would protest a government agency that prevented the sale of Saturn’s new Aura in favor of established competitors. Why should we let the FDA get away with such behavior?

2. federalist - November 20, 2007

Don’t miss Alex Tabarrok’s detailed study, “Assessing the FDA via the Anomaly of Off-Label Drug Prescribing.”

Richard Merrill, a former chief counsel of the FDA, wrote that “it is always safer for agency officials to prevent the marketing of products that entail physical risk—regardless of what benefits they provide. No FDA official has ever been publicly criticized for refusing to allow the marketing of a drug. Many, however, have paid the price of public criticism, sometimes accompanied by an innuendo of corruptibility for approving a product that could cause harm.”

Patients and doctors do not face the same biased incentives as the FDA and thus tend to pay more attention to the costs of not using a drug that could save a life.

From his conclusion:

Studies of the FDA’s post-1962 powers consistently find few benefits and large costs. … [A]nalysis of off-label prescribing strongly suggests that the FDA’s authority over new drugs, particularly the requirement that new drugs be tested for efficacy, is detrimental to the public’s health and welfare and therefore should be abolished.

3. federalist - December 18, 2007

Just found a good essay published in Reason, “Locking Up Life-Saving Drugs,” on the history of drug regulation that explains the bizarre origins of our prescription system.

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