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Drug Tests' Costly Side Effects

Pediatric trials only drive up prices.

November 04, 2002|Henry I. Miller

Antibiotics or a tube of prescription steroid cream used to cost a few bucks, but now the prices are soaring. A few examples of the cost of a week's supply of drugs: the antibiotic clarithromycin, $63; celecoxib, for arthritis, $85; and erythropoietin, for anemia, $218.

In large part, this is your tax dollars at work. Government regulation imposes, in effect, enormous taxes on drug development that are ultimately passed along to consumers. They also decrease innovation and the number of drugs that are developed.

A prime example of flawed policy is the FDA's 1997 decision to require drug companies to test in children the medicines they sell for adults. The good news is that last month a federal court nullified the policy. "The pediatric rule exceeds the Food and Drug Administration's statutory authority and is therefore invalid," said Judge Henry H. Kennedy Jr. of the District of Columbia federal court.

The bad news is that Sen. Hillary Clinton (D-N.Y.), who championed the policy during the Clinton years, is now the chief Senate proponent of legislation to turn the testing requirements into law.

Pediatric trials of new medicines might sound like a good thing, but this one-size-fits-all requirement ignores the realities of drug testing.

The FDA can, for instance, withhold approval of new drugs even for adult uses while the required pediatric studies are completed. The regulation is a rigid, centralized government solution to what is usually a nonproblem.

Even the FDA concedes that physicians commonly and safely prescribe pain relievers, asthma drugs, antihistamines, antibiotics and other therapeutics millions of times annually for children, without separate clinical trials. Even in cases where additional testing of drugs in children is needed, there are more imaginative and effective ways to accomplish it.

Federal law already offers financial incentives, in the form of extended patent rights, to companies that voluntarily perform pediatric testing. The FDA could also require a prominent label on drug preparations whose safety and efficacy had not yet been determined in children and publish a list of such drugs annually.

Creating a formulation for children is often challenging, tedious and expensive. Can the active ingredient be incorporated in a chewable or syrup form? Will it have adequate shelf life? A pediatric form of Glaxo Wellcome's antibiotic Ceftin required more than double the development cost and man-hours of the adult drug. The same company also struggled to find effective preservatives for its pediatric syrup form of Epivir, an AIDS drug, even after the adult formulation was fully developed.

Clinical trials are especially difficult with children. Study participants may be scarce because a disease is rare in children and subjects are few, or because parents are reluctant to enroll their sick children in an "experiment."

Also, "children" are not a homogeneous group, but encompass newborns, infants, preschoolers, primary-schoolers and teenagers, confounding the analysis of data.

As regulatory requirements overall are shoved upward, the approval pipeline slows. The time from synthesis of the new drug molecule to the patient's bedside has almost doubled over three decades, from 8.1 years to 15.2 years. And the United States' $800-million tab for each drug approved is by far the most expensive in the world.

Why does the FDA impose unnecessary, expensive regulations? As former FDA Commissioner Frank E. Young used to say: "Dogs bark, cows moo, and regulators regulate."

The FDA's pediatric testing requirement is Big Brother-ism at its worst, with the government deciding where private-sector research and development resources are best spent.

Sen. Clinton and the Senate, instead of approving legislation to restore the FDA rule, should let it quietly expire.

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Henry I. Miller is a fellow at the Hoover Institution and author of "To America's Health: A Proposal to Reform the FDA." He was an FDA official from 1979 to 1994. E-mail: miller@hoover.stanford.edu.

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