Why the FDA wants to limit your freedom

By Henry I. Miller Copyright 1998 The Washington Times July 6, 1998

Let's suppose you're picking up a prescription at the drug store. Responding to your inquiry about the drug having been prescribed for what seems an unlikely use - say, a blood pressure-lowering drug for muscle pain - the pharmacist gives you a copy of an article from a prominent medical journal. Well, it's possible that under a new federal policy, such an action by the pharmacist would not only be illegal but that the drug's manufacturer would also be held legally responsible.

The FDA is already the most powerful regulatory agency in the federal government, and now the agency's reach could extend considerably further.

The FDA recently published a draft guidance document aimed at regulating "medical product promotion" among health care providers and professionals. While its stated goal is to deter pharmaceutical manufacturers from promoting their own products through health care organizations and insurers, the FDA proposal could reduce industry competition, increase drug prices and damage public health.

This draft plan could also exert a chilling effect on the beneficial exchange of information among various segments of the health care industry and eventually between health care providers and patients. Moreover, it is hopelessly vague, duplicates regulatory functions already being performed by other government agencies and exceeds the FDA's statutory mandate.

The FDA's statutory authority covers a manufacturer's product labeling and advertising, primarily to deter labeling or advertising that is false or misleading. That is plausible. But this new action would extend the agency's regulatory authority to any "relationships" it deems promotional that occur between different members of the health care profession.

For example, the FDA argues that if any "subsidiary" of a drug manufacturer promotes a drug, the parent company bears full legal responsibility. But the agency says that "subsidiary" is "to be interpreted in its broadest sense to include any corporate relationship," no matter how remote, and that a company which has a relationship with "an independent contractor or agent becomes responsible criminally for the failure of the person to whom he has delegated the obligation to comply with the law."

In theory, that could make the manufacturer share the legal "blame," were a pharmacist to give a patient a medical journal article that was circulated by a health care organization and contained current information about the use of an FDA approved drug, but for a purpose not yet sanctioned by the FDA.

Sound far-fetched? Actually, the FDA has often prohibited the distribution of textbooks and journal articles to health care professionals because they alluded to off-label uses.

Like any other profession, people in the health care field talk to one another. But under the new FDA proposal, even the most basic and innocuous health care communications between people in the industry could be labeled "promotional." Health care organizations might well decide what information to distribute to patients not on the basis of its accuracy and usefulness, but according to their perceived "relationship" with manufacturers.

The ambiguous yet imperious nature of the FDA proposal could stifle competition and drive up costs. Organizations that deliver health care depend on peer-reviewed clinical information about drugs' effectiveness. They also use their purchasing power to get discounts from manufacturers. Under the draft proposal, sharing this kind of information or having such volume-based discount arrangements could constitute a suspect "relationship."

The FDA proposal wanders into areas where other agencies already protect the consumer; the FDA cannot, therefore, claim to be filling a regulatory void. State attorneys general and the Federal Trade Commission set industry standards for disclosure of a manufacturer's relationships, for example. Clinical programs are regulated by state boards of medicine and pharmacy. The federal Health Care Finance Administration regulates reimbursement, discounting, self-referral, kickbacks, fraud and abuse under rules that bind all health care organizations. These regulatory bodies are better suited to monitor health care communications than the FDA.

Vague directives are particularly dangerous because they allow the government wide discretion (read "capriciousness") about what is regulated and what is prohibited. The FDA draft proposal is an example of what economist Milton Friedman has called a government agency contravening the free market because it mistrusts freedom itself. The pity is that the FDA will probably get away with it because so few Americans now cherish that freedom.

Henry I. Miller is a senior research fellow at Stanford University's Hoover Institution and the author of "Policy Controversy in Biotechnology: An Insider's View."

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