FDA oversteps bounds with vague, new rule

July 15, 1998|By Henry I. Miller

STANFORD, Calif. -- Let's suppose you're picking up a prescription at the drugstore.

Responding to your inquiry about the drug's having been prescribed for an unlikely use -- say, a blood-pressure drug to treat your 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, not only would the pharmacist's action be illegal, but also the drug's manufacturer would be held legally responsible. No good deed goes unpunished by the government.

The Food and Drug Administration is the most powerful regulatory agency in the federal government. It oversees products that account for more than 25 cents of every consumer dollar, more than $1 trillion annually, including cardiac pacemakers, X-ray machines, condoms, home pregnancy-testing kits, drugs, vaccines, artificial sweeteners and fat substitutes.

An overreaching proposal

A proposal by the agency would extend that reach considerably. The FDA recently published a draft of regulations aimed at controlling "medical product promotion" among health-care providers and professionals.

While the 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.

It could also exert a chilling effect on the beneficial exchange of information among various segments of the health-care industry and could eventually interfere with essential communication between health-care providers and patients.

Moreover, it is hopelessly vague, duplicates regulatory functions performed by other government agencies and exceeds the FDA's statutory mandate.

The agency's authority covers a manufacturer's product labeling and advertising, primarily to deter what's false or misleading.

But this new action would extend the agency's regulatory authority to any "relationships" between members of the health-care profession that it deems promotional.

Not only is this a giant step beyond the FDA's legal authority, but the proposal's wording is so deliberately vague that it could effectively shut down vital communication between professionals and patients.

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.

A company that 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."

A tough law

In plain English, the manufacturer is responsible, even if it neither approved nor knew about the actions in question.

This could, in theory, make the manufacturer share the legal "blame" were a pharmacist to give a patient a medical journal article with current information about using a drug for a purpose not yet sanctioned by the FDA, if the article had been circulated by a health-care organization.

Some 40 percent to 50 percent of all drugs are prescribed for such "off-label" uses, including 60 percent to 70 percent of drugs used to treat cancer and 90 percent of drugs administered to children.

Does all this sound far-fetched? It's not. The FDA has often prohibited distribution of textbooks and journal articles to health-care professionals because they alluded to off-label uses.

Anti-business stance

The agency has even prohibited manufacturers from holding focus groups prior to a drug's approval. These groups could help the drug companies determine how to make their labeling and packaging more user-friendly for doctors and patients.

As in any other profession, people in the health-care field talk to one another.

But under the FDA proposal, even the most basic and innocuous communications between people in the industry could be labeled "promotional" and prohibited by FDA censors.

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 to enhance the quality of health care and to lower costs.

They also use their purchasing power to get discounts from manufacturers, bringing competition into the marketplace.

Under the proposal, sharing this kind of information or having volume-based discount arrangements could constitute a suspect "relationship." And that could eliminate these cost-saving competitive influences, ultimately raising costs.

The proposal plainly wanders into areas where other agencies already protect the consumer. The FDA cannot 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, whose mission is to assure the safety and efficacy of products.

Vague directives are particularly dangerous because they allow the government wide -- even capricious -- discretion about what is regulated and what is prohibited.

The pity is that the FDA will probably get away with it because so few Americans now cherish that freedom.

Henry Miller, an FDA official from 1979 to 1994, is a fellow at Stanford University's Hoover Institution.

Pub Date: 7/15/98

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