The Drug Approval Pendulum

“It just breaks my heart when I think of American citizens having to go to Switzerland or Mexico to get the drugs and devices they need to stay alive because the Washington bureaucracy won’t approve them.”
— Rep. Thomas Bliley (R-Va.), 1995

“When the FDA approves a drug, it should be a Good Housekeeping seal of approval. . . . Consumers shouldn’t have to second-guess the safety of what’s in their medicine cabinet.”
— Sen. Chuck Grassley (R-Iowa), 2005

Most of the time, when we use the word “fashion,” we are talking about hemlines, or footwear, or shades of nail polish. But there are also intellectual fashions, literary fashions, political fashions. In fact, almost any sphere of human activity is subject to abrupt shifts in conventional wisdom: Even the arcane world of pharmaceutical regulation is afflicted by highly emotional mood swings.

To see what I mean, think back to the early 1990s. It was a time when new drugs promised to give AIDS patients their lives back. It was a time when many medical breakthroughs seemed just around the corner. It was also a time when critics of the Food and Drug Administration angrily claimed, among other things, that “more than 20,000 people died between 1985 and 1987,” waiting for FDA approval of a drug that could have unblocked their arteries, and that “3,500 kidney cancer patients had died between 1988 and 1992” for lack of access to a drug already “available in several European countries.” And it was a time when patient advocates could take out ads with messages such as: “If a murderer kills you, it’s homicide. If a drunk driver kills you, it’s manslaughter. If the FDA kills you, it’s just being cautious.”

It was also a time when congressional Republicans were in the throes of a full-throttle attack on the staid old drug regulation agency. House Speaker Newt Gingrich (R-Ga.) called the FDA the “leading job killer in America.” House Commerce Committee Chairman Joe Barton (R-Tex.) declared that the FDA should stop ruling on the efficacy of drugs at all and stick to measuring whether they are “safe, pure, and packaged safely.”

Thanks to sentiments such as these, Congress in 1992 passed the Prescription Drug User Fee Act. Among other things, the new law pressured drug regulators to speed up their review procedures, even rushing some life-saving drugs through the approval process in a mere six months. The law was reauthorized. Twice.

For a short time, harmony reigned. But then the pendulum began to swing, the winds of fashion began to blow in a different direction, and the FDA, once a bureaucratic monolith bearing down on the brave new world of pharmaceutical research, somehow managed to become the FDA, a bureaucratic castrato cozying up to the greedy pharmaceutical companies.

True, the FDA was only doing what Congress said it wanted. The drug approval process was speeded up, and new drugs did get to patients more quickly. Death ceased to be inevitable for those with AIDS. Other diseases were cured more rapidly, too. But it is also true that the new speed may have led to mistakes. By 2000 the FDA had been forced to withdraw nine drugs, among them a diabetes drug, Rezulin, that was found to cause liver problems, and Lotronex, a treatment for irritable bowel syndrome that was later re-approved with heavy warnings. The former had been approved after six months, the latter after eight months.

More recently, Merck & Co., the manufacturer of Vioxx, a hugely popular, billion-dollar painkiller, withdrew its drug from the market in the face of new evidence that the drug caused heart problems. As a result, the agency came under public attack. But instead of expressing contrition — or even defending its original push to speed up drug approvals — another Republican Congress once again denounced the FDA. “We’ve seen some evidence over the last year that the agency has become too cozy with the drugmakers,” thundered Grassley, who has proposed creating a brand new office of drug safety, independent of the FDA. At his Senate confirmation hearing, Lester Crawford, the proposed FDA commissioner, wound up denying that his agency had been “tarnished” and promising “to stem the tide and do the right thing.” Even so, a number of senators spoke afterward of a “crisis of confidence” in the agency and expressed concern that “business as usual” not continue to be its motto.

And the result? Last week the FDA, now in a panic over painkillers and terrified of further congressional and public criticism, banned the arthritis drug Bextra. The agency has also called for strong warning labels to be placed on all anti-inflammatory drugs, including over-the-counter painkillers such as Aleve and Motrin, as well as Celebrex, a close relative of Vioxx.

Clearly, caution is now “in.” Patients’ rights are “out.” Risk-averseness is “in.” Hot new research is “out.” “There is no doubt that there has been a cultural change,” the director of the FDA’s Office of New Drugs told a reporter last week. And there is no doubt that Congress, along with everybody else, sincerely believes that the change is, will be, and should be permanent. How little we know of fashion!

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