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Longtime readers of CEI UpDate may recall that the Competitive Enterprise Institute has, in past years, conducted polls of medical specialists as part of our work on Food and Drug Administration reformone of cardiologists, completed in July 1996, and one of oncologists, completed in August 1995. The doctors we surveyed thought that the FDA was 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. A new CEI survey of neurologists and neurosurgeons suggests that these views were not idiosyncratic.
During the past few years, congressional reformers began to exert political pressure on FDA, forcing it into accelerating its review process and making several important procedural changes. The average length of New Drug Application review times fell by nearly half between 1989 and 1997. Without the force of statute behind them, however, those procedural advances were prone to reversal once FDAs congressional overseers moved on to other concerns.
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, enshrining into law some of FDAs recent improvements. Although the Competitive Enterprise Institute has insisted that much additional reduction of FDAs authority is needed, the Modernization Act certainly represents an important step in the direction of more substantive reform.
Unfortunately, a backlash has begun. Some critics now argue that the 1997 reforms went too farthat FDA now has become too hasty in its approval of new drugs and devices. The view of many doctors, however, suggests otherwise. In August, CEI commissioned a poll of neurologists and neurosurgeons to examine their views of the FDA. 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. As with CEIs two previous polls, the results of this survey demonstrate that we still face a very serious problem regarding delays in the approval of new drugs and medical devices.
Once manufacturers submit new product applications for approval, federal law requires FDA to pass judgement on the proposed treatments within six months. However, the agency routinely takes much longer to review applications. Two-thirds (67%) of the respondents believed that the FDA is too slow in approving new drugs and devices. More than half (58%) believed that the additional time it takes to approve new drugs and devices costs lives by forcing patients to go without potentially beneficial treatments. A striking 80% of respondents said that the FDAs approval process has hurt their ability to treat patients with the best possible care at least once. Yet nearly three-quarters (73%) believed that the general public has little or no understanding of these "human costs" of the FDA approval process.
Once the FDA approves a new drug or device for a particular purpose, physicians are able to prescribe those treatments for any condition they think is appropriate. However, manufacturers are prohibited from disseminating information about unapproved uses. Nearly four out of five (79%) respondents in our survey believed that the FDA should not restrict information about unapproved, or "off-label," uses of drugs and devices. An equal number (79%) believed that FDAs policy of limiting such information makes it harder for them to learn about new uses for approved drugs and devices.
As in the previous polls, this survey indicates that respondents are dissatisfied with the slow pace of the FDA approval process, and that they support significant change in federal food and drug law. We were surprised to find, however, that a very large majority (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.
"A National Survey Of Neurologists And Neurosurgeons Regarding The Food And Drug Administration" contains a side-by-side comparison with the results of CEIs two previous. 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 combined weight of all three polls lends support to the concept of expanded physician access to unapproved drugs and devices. CEI has long proposed stripping the FDA of its veto authority over experimental drugs and devices. The FDAs safety and efficacy standards would remain as they are, but patients should be allowed to use unapproved drugs and devices under medical supervision and with the clear knowledge that FDA has not certified them. Under such an arrangement, the FDA could be as cautious as its politics required, but its overcaution would no longer be deadly.
Gregory Conko is a Policy Analyst at the Competitive Enterprise Institute.