Published January 12, 2001

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Guest op-ed

Much of the real work of the new Bush administration will be done not by the high-profile members of the president’s cabinet who are now being appointed, but rather by the more than seven thousand sub-cabinet level appointees, including agency heads. A case in point is the head of America’s most ubiquitous—and arguably most intrusive—regulatory agency, the Food and Drug Administration.

The position of FDA Commissioner will be particularly difficult to fill this time around, with various forces pulling in different directions: the agency’s desperate need for reorganization and reform, any nominee’s need to survive the confirmation process in the evenly-split Senate, and the campaign of disinformation about the FDA’s policies that is currently underway.

Has the FDA Gone Soft?

What kind of disinformation? Critics of the pharmaceutical industry are trying to convince consumers that during the past decade, the FDA has relaxed the oversight of prescription drugs and compromised consumer safety.

For example, Sidney Wolfe, of the Washington-based Public Citizen Health Research Group, wrote in The Washington Post that “[e]gged on by its sponsors in the drug industry, Congress has systematically set about weakening a drug-approval process that for years ensured Americans the safest pharmaceutical supply in the world.” The Los Angeles Times made a similar claim, citing as evidence several recent instances of drugs being recalled from the market, and data showing that between the beginning and the end of the last decade, the number of drugs approved by the FDA jumped eighteen percent, while the review times for marketing approval dropped by about a third.

Some have suggested that the FDA weakened its oversight following President Clinton’s admonition to regulators to treat industry as “partners, not adversaries” and the 1992 passage of the Prescription Drug User Fee Act, which requires that drug manufacturers pay a fee–a tax, actually–to the agency to supplement the funds that Congress appropriates.

These fees, which amount to about $100 million a year and must be used only for drug review, appear to have had an impact. The headline of an October 2000 article from the distinguished Tufts University Center for the Study of Drug Development trumpeted, “User fees credited with 51percent drop in average approval times since 1993.”

‘Quick and Dirty’ FDA Reviews? No Way.

Do these statistics mean that FDA regulators have become more productive—or, more ominously, that they have lowered their standards, maybe even doing quick and dirty evaluations?

Actually, neither. The time required for the final FDA review—evaluation of the New Drug Application, approval of which permits marketing of a product—is not an accurate reflection of the stringency and control imposed by the FDA on drug testing. Careful consideration of all the data reveals that the intrusiveness and length of the FDA’s overall regulation of drugs have been increasing, not decreasing.

Those who criticize the drug industry, and the FDA’s allegedly lenient treatment of it, emphasize the FDA’s slightly shorter review times for granting marketing approval of drugs. But some of that improvement is merely an artifact of a new policy, called “refusal to file,” under which the FDA rejects an application for marketing approval if it isn’t complete and in good order. This has had the effect of starting the “approval clock” later, and making the review times appear shorter, when they really are not.

In any case, that review for marketing approval is only the final phase of a very long, complicated, multi-step process. Those who allege a trend toward less regulatory rigor pointedly ignore the more-than-offsetting increases in the overall time for drug development.

According to data from the Tufts University Center for the Study of Drug Development, the time from synthesis of a new drug to marketing approval increased from an average of 14.1 years during the 1980s to an average of 15.2 years between 1990 and 1996. In addition, the total time required for drug development has more than doubled since the 1960s.

FDA Keeps Raising the Bar—and Development Costs

Finally, the time required to develop a drug isn’t the entire story; the price of the development process to the company is highly significant, too.

Bringing a single new drug to market in the United States now costs the manufacturer on average more than $400 million, by far the highest price tag in the world. And a Duke University study reveals a sobering corollary—fewer than three out of every ten drug products generate revenues that cover their development costs.

Why is drug development so expensive? Certainly not because of a dearth of technology: biotechnology, combinatorial chemistry, sequencing of the human genome, improved purification techniques and other innovations have made drug research more efficient.

Costs are spiraling out of control because the FDA meddles endlessly in clinical trials and keeps raising the bar for approval. The average number of clinical trials performed on an average drug increased from 30 in the early 1980s to 68 during 1994-95, while the average number of patients in clinical trials for each drug more than tripled.

Furthermore, the average time required for clinical trials of a new drug increased from 85 to 92 months from the first half of the 1990s to the second half. This is all evidence of tightening, not weakening, of FDA’s already-stultifying regulation.

Will the Bush Administration Reform the FDA?

During the past few years the FDA has continued to propose and implement rules and policies that add further costs and time to the development of new drugs, with little or no additional protection of public health.

Such policies are pernicious. Drug companies increasingly can afford to develop only products that are potential financial blockbusters, while drugs for life-saving but narrower uses are neglected. Already-huge drug companies find it necessary to merge in order to achieve even greater economies of scale.

These trends should be cause for alarm. Fewer drugs will be developed, and those that do emerge from the pipeline will have inflated prices. Many patients needing new therapies will, literally, pay with their lives—but not because drug regulation is too lenient. Quite the opposite. It remains to be seen how strong will be the Bush administration’s prescription for more sensible regulation.

Henry I. Miller, MD, is a fellow at the Hoover Institution and the Competitive Enterprise Institute, a former official at the FDA, and the author of “To America’s Health: A Proposal to Reform the FDA.” His e-mail address is miller@hoover.stanford.edu [2].

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