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Oncologists Still Call FDA Too Slow to Approve Drugs but Opinion Better than in 1995 Poll

Eastman, Peggy

doi: 10.1097/01.COT.0000292671.83906.ae
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WASHINGTON, DC—According to a new poll, 61% of oncologists believe that the Food and Drug Administration is too slow to approve new drugs and devices, and 68% favor a change in FDA law to allow them to use unapproved drugs and devices as long as such products carry a warning.

Results of the poll commissioned by the Competitive Enterprise Institute (CEI) were released at a news briefing here. The organization describes itself as a nonprofit, nonpartisan public policy group dedicated to free enterprise and limited government.

The telephone poll, posted online at www.cei.org, included 160 oncologists (48% of whom had been in practice for more than 15 years) in a sample obtained from the American Medical Association. The poll was released just a day before the publication of a new study in the Journal of the American Medical Association suggesting that the FDA approval process is not too slow, and showing that serious adverse drug reactions frequently emerge after FDA approval of new drugs (see box).

“If FDA approves a new lifesaving drug today, how many people will have died yesterday waiting for this drug?,” asked CEI General Counsel Sam Kazman. He added that CEI believes the FDA suffers from “deadly overcaution,” and that “for many people, delays in lifesaving therapies are a critical matter.” These people, he said, are simply less visible than those who have been harmed by a drug.

Noting that CEI has been “praised, blasted, and ignored” for its policy stances, Mr. Kazman said changing FDA law to allow physicians to use unapproved drugs as long as they carry a warning on their unapproved status is seen “as an incredibly radical view” by some.

However, the fact that 68 percent of the oncologists surveyed strongly favor this strategy shows, he said, “that they feel their profession is capable of handling unapproved drugs.”

Potential Liability

Asked about potential liability, Mr. Kazman said he believes physicians' liability in using unapproved drugs with warnings would be comparable to that of prescribing drugs for off-label uses.

The percentages are better than a similar poll in 1995, when 77% of oncologists said they thought the FDA was too slow in approving new drugs and devices.

CEI has been studying the drug-approval process for the last several years, along with its effects on oncologists and other specialists, he said. “The research shows that doctors were not only fighting cancer, they were fighting FDA as well.”

CEI last polled oncologists on the FDA drug-approval process in 1995; it polled cardiologists in 1996; neurologists and neurosurgeons in 1998; and emergency physicians in 1999.

The oncology poll shows that oncologists believe there have been improvements. In 1995, 77 percent of oncologists said they thought the FDA was too slow in approving new drugs and devices, compared with 61 percent in 2002. In fact, in the 2002 poll, 48 percent of those surveyed said that over the last five years their opinion of the FDA on specific issues related to new drug and device approval had gotten better.

However, the oncologists were clear that the FDA is still as much of a hindrance as a help to them. Some 43 percent of those polled said FDA regulations “totally help” them in using promising new drugs or devices in treatment of their patients, while 44 percent said such regulations “totally prevent” them from doing so.

Congress Planning to Reauthorize Prescription Drug User Fee Act

The new poll comes at a time when Congress is planning to reauthorize the Prescription Drug User Fee Act (PDUFA) which provides the FDA with money for the drug-review process from pharmaceutical manufacturers seeking new drug approvals.

In a statement released at the briefing, Carl F. Dixon, President and CEO of the Kidney Cancer Association, said that Congress should “carefully review” the opinion of oncologists—as revealed by the CEI poll—on the FDA's performance as it prepares to reauthorize the act.

In 1992, the Competitive Enterprise Institute attacked the FDA for its slow approval of interleukin-2, which was approved in that year for treating metastatic renal cell carcinoma. At that time, CEI claimed that the FDA's foot dragging may have cost as many as 3,500 lives, while the FDA vigorously defended its timeline as necessary for patient safety.

Senator Bill Frist, MD (R-TN), who cosponsored legislation in 1997 to reform the FDA, said the new survey of oncologists shows “a mixed bag of opinions” from cancer specialists, but that it is nonetheless a good sign that nearly half of the respondents felt that the FDA had improved its drug-review process.

“The FDA has made tremendous progress toward streamlining its review and approval process without compromising drug safety,” said Senator Frist, the Senate's only doctor and the ranking member of the Senate Subcommittee on Public Health.

“In 1997, Congress implemented significant FDA reforms. What used to take several years has now been reduced to an average review time of six to 10 months. Yet, as many respondents indicated, more needs to be done to further improve the drug review process.”

FDA Comment

Asked to comment, Crystal Rice, a spokesperson for the FDA's Center for Drug Evaluation and Research, noted that the Agency's approval times have begun to increase because more applications require more back-and-forth communications with the sponsors for the process of getting answers to reviewers' questions and to complete the information needed for the new PDUFA goals for drug development.

“The reviewers have had less time for resolving last-minute problems with standard applications, before the action goal date, and therefore such applications must undergo an additional review cycle with its attendant timeframes and goals,” Ms. Rice said.

61% of oncologists surveyed think the FDA is too slow to approve new drugs and devices, and 68% favor a change to allow use of unapproved drugs and devices as long as such products carry a warning.

In addition, she pointed to a statement by John Jenkins, MD, Director of the Center's Office of New Drugs, in another context, noting that the number of applications coming in to the FDA has dropped, and that there are more standard applications (which average a review of about 12 and a half months) and less priority applications (which average about six months).

“FDA believes that PDUFA is very successful and that the timeframes for review have decreased 12 months overall since pre-PDUFA. FDA is meeting a goal level for application review of more than 90 percent now,” Dr. Jenkins stated.

Other ighlights of the Survey

  • ▪ Almost 8 of 1 oncologists (77%) said the DA's approval process has hurt their ability to give their patients the best possible care at least once during their careers.
  • ▪ 58% of oncol ogi sts surveyed sai d that i f a drug or devi ce has al ready been ap-proved for one use by the DA, then the agency shoul d not restrict information about its off-label uses; 65% said the DA policy of limiting off-label information has made it more difficult for them to learn about new uses for drugs or devices.
  • ▪ 6% of respondents said the additional time it takes for the DA to approve medi cal drugs and devices costs lives by “forcing people to go without potentially beneficial therapies.”
  • ▪ 7% of oncologists polled said the general public does not understand the “human cost” of the DA approval process that is, “that some people may suffer or die waiting for the DA to act.”

JAMA Study: Serious ADRs Emerge after New Drug Approval

The FDA's new drug approval process is not only not too slow, but also does not catch some significant adverse drug reactions (ADRs). That was the conclusion of a study published in the May 1 issue of the Journal of the American Medical Association (2002;287:2215–2220).

Karen E. Lasser, MD, MPH, of Harvard Medical School and her colleagues who included Sidney Wolfe, MD, of Public Citizen Health Research Group, found that it was not unusual for serious ADRs to emerge after a drug has been given the FDA's stamp of approval.

“The safety of new agents cannot be known with certainty until a drug has been on the market for many years,” the researchers wrote. For that reason, “clinicians should avoid using new drugs when older, similarly efficacious agents are available.”

The authors found that pharmaceutical companies frequently market new drugs heavily to both physicians and patients to increase sales before the full range of adverse drug reactions on these new therapies has been established.

The FDA's Center for Drug Evaluation and Research Policy provided a rebuttal in an accompanying editorial stating that labeling changes are “inevitable and should be anticipated” with newly approved drugs. But, said FDA authors Robert J. Temple, MD, and Martin H. Himmel, MD, serious ADRs in newly approved drugs are not common, and the introduction of unsafe drugs after the FDA drug-review process is rare.

The Institute of Medicine has identified adverse drug reactions as a leading cause of death in the United States.

© 2002 Lippincott Williams & Wilkins, Inc.
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