Doctors, patients, and public policy experts have long claimed that the FDA is too slow in approving new drugs and medical devices, and that the added time it takes to navigate the complex FDA approval process costs lives by denying patients potentially beneficial new treatments. Naturally, when the Food and Drug Administration Modernization Act of 1997 became law last November 11th, it was seen by many observers as the rightful culmination to a roughly three-year struggle for FDA reform.
While some groups, including the Competitive Enterprise Institute, have suggested that even more reforms are needed, others now argue that the 1997 reforms went too far. 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. CEI commissioned this poll of neurologists and neurosurgeons to examine their views of the FDA. A majority of the respondents believe that the FDA is too slow in approving new treatments, and that these delays cost lives. As the results of this survey demonstrate, we still face a very serious problem regarding delays in the approval of new drugs and medical devices.
This poll indicates that most neurologists and neurosurgeons are dissatisfied with the slow pace of the FDA approval process, and that they support significant change in federal food and drug law. Here are some of the survey’s most striking results:
- Two-thirds (67%) of respondents believe that the FDA is too slow in approving new drugs and devices.
- More than half (58%) 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.
- Nearly four out of five (79%) 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. An equal number (79%) believe that FDA’s policy of limiting such information makes it harder for them to learn about new uses for approved drugs and devices.
- A striking 80% of respondents said that the FDA’s approval process has hurt their ability to treat patients with the best possible care at least once.
- 73% of the neurologists and neurosurgeons surveyed said that they would 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 final results, a brief analysis of those results, and a side-by-side comparison with the results of two previous CEI polls—one of cardiologists completed in July 1996, and one of oncologists completed 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. A majority of the respondents in each poll agreed that the FDA is too slow in approving new drugs and devices, and that there is a human cost to this delay.
The weight of the three polls also lends support to the concept of expanded physician access to unapproved drugs and devices. CEI has long proposed that the FDA’s safety and efficacy standards could remain as they are, but that patients be allowed 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, now being considered in Congress, offers a similar approach. With such an arrangement, the FDA could be as cautious as its politics required, but its overcaution would no longer be deadly.
Gregory ConkoPolicy AnalystCompetitive Enterprise InstituteOctober 5, 1998