The US Food and Drug Administration is among the most highly regarded agencies of the federal government. But for more than two decades, doctors, patient groups, and public policy experts have argued that FDA’s lengthy process for approving new drugs and medical devices often costs lives by denying patients potentially beneficial new treatments. Beginning in the early 1990s, those complaints began to be taken seriously by Congress and the agency. This resulted in a slow progression of legislative and regulatory changes, culminating in passage of the Food and Drug Administration Modernization Act of 1997.
Though the goal of most of these changes was to increase the speed at which beneficial new products reach the market, additional reform is needed. The Modernization Act grants FDA authority to reduce the number of clinical trials needed for approval and to expedite the review of treatments for serious conditions, but does not require it to do so. The Act grants manufacturers broader freedom to disseminate information about “off-label” uses of approved drugs, but does not revoke the agency’s often heavy-handed oversight of that practice.
The average length of time it takes the FDA to review New Drug Applications has fallen from roughly 30 months at the beginning of the decade to 17 months today.1 But that is still three times as long as sanctioned under law,2 and is in addition to an average of six years of clinical testing.1 Furthermore, FDA recently implemented a new regulation requiring drug manufacturers to test in children many of the drugs they sell for adults before the drugs can be approved. This is likely to add substantially to development and testing times, keeping new treatments off the market even longer.
The Modernization Act and some of the other recent changes were certainly modest steps in the right direction. However, by leaving the agency too much discretion in resolving issues of concern, they failed to address FDA’s innate flaw: By granting FDA sole approval authority, the statutory framework for drug and device regulation gives the agency the power to decide for all patients whether or not the potential benefits of new drugs and devices are worth the risks that those treatments may pose. Such very personal decisions are best left to patients and their doctors.
Today, other critics argue that the FDA’s recently expedited reviews have endangered public health by allowing dangerous new drugs onto the market. That position, however, is not supported by many patient groups nor by many practicing physicians. CEI commissioned this poll of emergency room doctors to examine their views of the FDA and its review process. ER doctors treat critically ill patients on a dailybasis, and they understand the need for groundbreaking new therapies. Consequently, their views of FDA are especially relevant.
This survey indicates that, even today, most emergency room physicians believe that the FDA is too slow in approving new treatments, and that these delays cost lives. Despite recent changes, doctors remain dissatisfied with the slow pace of the FDA approval process, and they support significant change in federal food and drug law. Here are some of the survey’s most striking results:
+ Nearly two-thirds (64%) of respondents believe that the FDA is too slow in approving new drugs and devices.
+ More than half (51%) believe that the additional time it takes to approve new drugs and devices costs lives by forcing patients to go without potentially beneficial treatments. Yet nearly three-quarters (73%) believe that the general public has little or no understanding of this “human cost” of the FDA approval process.
+ Four out of five (82%) respondents believe that the FDA should not restrict information about unapproved or “off-label” uses of drugs and devices that have been approved for a different use. And most (77%) believe that FDA’s policy of limiting such information makes it harder for them to learn about new uses for approved drugs and devices.
+ Perhaps most noteworthy, 69% of the emergency room physicians surveyed said that they favor changing federal law so that unapproved drugs and devices could be made available to physicians as long as they carried a warning about their unapproved status.
This report contains the survey questionnaire and results, a brief analysis of those results, and a side-by-side comparison with the results of three previous CEI polls—one of neurologists released in October 1998, one of cardiologists released in July 1996, and one of oncologists released in August 1995. This side-by-side comparison suggests that negative attitudes toward the FDA are common among medical specialists who are most in need of innovative new therapies, and that those views are consistent over time.
CEI’s four polls lend support to proposals that would allow patients to use unapproved drugs and devices under medical supervision and with the clear knowledge that FDA has not certified them. The Access to Medical Treatment Act (H.R. 2635), introduced in the US House of Representatives by Congressman Peter DeFazio in July, offers one approach. Under such an arrangement, the FDA could be as cautious as its politics required, but its overcaution would no longer be as deadly.