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The Food and Drug Administration Modernization Act of 1997—signed into law one year ago this Wednesday—is under attack. Spurred by the withdrawal of two new medicines this summer, critics say the reforms force FDA to make dangerously rushed judgements when evaluating applications for new drug approvals. But the evidence—including a poll of neurologists just released by the Competitive Enterprise Institute—shows just the opposite. Contrary to the opinions of skeptics, the Modernization Act did not go nearly far enough.
The story begins several years ago when, urged on by reformers, Congress began taking seriously complaints about FDA’s overcaution. A few pieces of narrowly targeted legislation, combined with increasingly stern oversight pressures, enabled the agency to make changes in the way it reviews new drug and device applications. The average length of drug review times dropped by nearly half between 1989 and 1996, but even that was still three times as long as sanctioned under law. Moreover, the agency imposed increasingly burdensome procedural requirements on manufacturers during the clinical trial phases of drug development. The net effect was to make the total time-to-market for new drugs longer, not shorter. Congress passed the FDA Modernization Act (FDAMA) last November to address these problems.
Failed to Address Innate Flaw. Among other things, the Act grants FDA authority (but does not require it) to reduce the number of clinical trials needed for approval, expedite the review of drugs for serious conditions, allow manufacturers to disseminate information about "off-label" uses of approved drugs, and permit expanded access to unapproved drugs in life-threatening cases. The Act is certainly a modest step in the right direction, but, by leaving the agency too much discretion in resolving these matters, it fails to address FDA’s innate flaw.
The FDA is prone to overcaution because the fundamental nature of politics demands it. If the agency approves a drug or device that later is found to be unsafe in some way, the public and politicians blame FDA for the error. However, if the agency delays when reviewing applications, the patients who need experimental new treatments are worse off. Some may die waiting for FDA to act, but neither they, nor their families are likely to be aware that a possible treatment exists—or that it was blocked by the FDA. Because no political pressure comes to bear for making the latter type of mistake, FDA’s natural tendency is to avoid making the first type of error.
Clearly, more needs to be done. But a real threat lies in the likelihood that Congress, having addressed the issue, will now consider the matter closed. Furthermore, the growing backlash against reform could cause FDA to relapse, using its broad discretionary authority to exacerbate existing problems. Lamentably, that backlash is beginning to be taken seriously. This summer, it was the subject of feature articles in both The New York Times and USA Today. Editorials in both newspapers suggested that FDA had, indeed, become to hasty in approving new drugs and devices.
Doctors See Problem. Nevertheless, many experts disagree. In a joint letter to USA Today, the Kidney Cancer Association, the American Cancer Society, and twenty-two other patient groups defended the recent reforms. They argued that slowing down the drug approval process "would hurt public health and harm the patients [they] represent by denying them the new treatments and cures they are so anxious to receive."
Those views were bolstered by a poll of neurologists and neurosurgeons released by the Competitive Enterprise Institute last month. Neurology is one of the many medical specialties whose members treat critically ill patients on a daily basis and who understand the need for groundbreaking new therapies. Among the doctors surveyed, two-thirds (67 percent) thought that FDA was too slow in approving new drugs and medical devices. More than half (58 percent) thought that the added time it takes to navigate the complex FDA approval process costs lives by denying patients potentially beneficial new treatments. Two previous polls commissioned by CEI—one of cardiologists in 1996, and one of cancer specialists in 1995—found similar results.
The surveys also show that most of those doctors support significant change in federal food and drug law to make medicines available more quickly. Majorities of neurologists (73 percent), cardiologists (53 percent), and oncologists (61 percent) said they would favor changing federal law to make unapproved drugs and devices available to physicians as long as they carried a warning about their unapproved status. Under such an arrangement, FDA’s safety and efficacy standards could remain as they are, but patients would be allowed to use unapproved drugs and devices under medical supervision and with the clear knowledge that FDA has not certified them. FDA could be as cautious as its politics required, but its overcaution would no longer be deadly.
Don’t Turn Back the Clock. Rather than allowing FDA to turn back the clock and slow down even further the approval of vital medicines, Congress should move forward, clearing away the regulatory barriers that tie the hands of doctors and their patients. Congress must view FDAMA as a stepping stone, not a stumbling block, to much more substantive reform.
1Gregory Conko (firstname.lastname@example.org ) is a Policy Analyst at CEI.2Pharmaceutical Research and Manufacturers of America, New Drug Approvals in 1997 (January 1998).321 USC 355 (c)(1).4Joseph A. DiMasi, "A New Look at United States Drug Development and Approval Times, "American Journal of Therapeutics, Vol. 3, No. 9 (1996)5Carl F. Dixon, "FDA’s high standards continue to save lives," USA Today (August 6, 1998), p. 12A.6Competitive Enterprise Institute, A National Survey of Neurologists and Neurosurgeons Regarding the Food and Drug Administration (October 1998).7Competitive Enterprise Institute, A National Survey of Cardiologists Regarding the Food and Drug Administration (July 1996); Competitive Enterprise Institute, A National Survey of Oncologists Regarding the Food and Drug Administration (August 1995).