The FDA vs. Reform

The FDA vs. Reform

June 07, 1996

Investor's Business Daily -- Guest Editorial

The FDA vs. Reform

by Julie DeFalcoFriday, June 7, 1996

Congress is pushing to reform the Food and Drug Administration. The FDA's answer? Fudge the data to spruce up its image.

In what's known as "drug lag," the FDA frequently delays the release of promising new therapies. Some patients die for want of new drugs and devices. And because approval time counts against the life of a patent, it forces firms to boost prices to recover their hefty R&D costs.

FDA head Dr. David Kessler recently told Congress to look at "the substantial progress that the... FDA (has) achieved over the past several years." But "progress" turns out to mean new ways to measure the lag -- or rather, to conceal it.

For example, the agency claimed last December that "FDA's tough standards do not delay consumer access to important new drugs, compared to other countries (Germany, U.K. and Japan).... The data clearly demonstrate that the United States has available valuable drugs as soon as, and in many cases, sooner than, its counterparts around the world."

In fact, the FDA only used data that would prove its claim. Its study only looked at new drugs put on the world market from January 1990 to December 1994. That left out the many drugs first introduced in Europe in the late '80s and then submitted for U.S. approval in '90s, as well as drugs still on hold here from the '80s.

The report also took care not to look at the key issue -- how long it took each drug to get through the FDA's Byzantine approval process. Thus, the FDA cited tacrine, a treatment for Alzheimer's, as a drug it had approved before the comparison countries. Yet tacrine's discoverer, Dr. William Summers, says the FDA "attempted to pull the plug on our research" and delayed the drug's availability for nearly five years.

The FDA does admit that more drugs are available in Britain than in the U.S. -- but says "there appears to be no drug of major public health interest to U.S. patients" among them. Such claims show the agency's paternal mindset. "It is only the FDA's judgement that other drugs are not that important," says Dr. Joe DiMasi of the Tufts University Center for the Study of Drug Development.

Kessler also showcases a 1995 General Accounting Office study he says shows the FDA's speed in processing new medical device applications (known as PMAs).

The report is more statistical sleight-of-hand. The FDA just switched from looking at the mean approval time to measuring the median. (The mean is the average, the median just the middle value of a set of numbers).

Why the change? The GAO report notes, "When the mean is larger than the median... it indicates that a group of applications required lengthy reviews." And that lag-time is just what the FDA hopes to hide.

The GAO also notes, "a large proportion of the applications have yet to be completed." And as these pending applications are reviewed, the mean will increase. The median, however, will stay the same -- a good thing for the FDA's image.

The genuinely relevant numbers show that the rate of PMA approvals stayed roughly constant from 1989 to 1994, while the actual number of PMAs submitted dropped by 50%. At the same time, the FDA got an 80% hike in funding and a 20% gain in personnel.

Indeed, higher budgets (and greater power) seem to matter more to Kessler's FDA than saving lives. One reform before Congress is to allow "third party review," a watered-down version of Europe's drug-approval system. This would let drug and device makers pay private, FDA-certified contractors to vet their new products. This would not change any FDA safety and efficacy criteria, and the agency would still determine final approval.

But Kessler said this "would perpetuate the kind of inappropriate and unproven medical practices that existed prior to 1962," when today's FDA was born.

Yet the FDA itself experimented with a third-party-review program a few years ago. It declared the program a success, but then dropped it. Why? A few months later, Congress allowed the agency to charge user fees to drug firms for speedier approvals. It looks like the FDA just wants the extra money for itself.

The FDA's bitter, dishonest stand against even modest reform is a disgrace. Kessler's actions show less concern for the health and safety of Americans than for the health and safety of his bureaucratic base of power.