US FDA Reform: Kessler Warns Of Lower Standards

US Food and drug Administration Commissioner David Kessler has told the Senate Labor and Human Relations Committee that while he "embraces the principles" of Committee chairman Senator Nancy Kassebaum's FDA reform plan, the FDA cannot further speed up rev-iews with its current funding without compromising public health. Changes in the bill are needed to ensure safety, he said, and setting shorter timetables for drug and medical device approval as well as the use of third parties in the review process are at the top of his list of concerns.

FDA critics still base their assessment on old data, he said, noting a recent General Accounting office study that showed new drug approval times had fallen from 33 months in 1987 to only 19 months now. The FDA's approval review process is better than or equal to those in the UK, Germany and Japan, he said, also noting the quick approval rates for new AIDS drugs. Shorter deadlines would mean reviewers could not spend time with companies to clarify questions and may then have to start further delaying approval, he said. Staff would have to be moved from other FDA work such as oversight of blood supplies and food safety, the only alternative being the lowering of standards. Using outside scientists who are often not familiar with a drug's development to review part of its application would only interrupt the process further and in the end slow any final approval.

Dr Kessler also opposed the bill's proposal to reduce needed clinical trials, in order to lower company costs and speed review time. This would reverse the current 1962 law that requires companies to "establish" that products work before they can be marketed. "We are approving drugs in very short time frames and one day we are going to make a mistake," he said, and noted that when the FDA rejected the blood pressure medication dilevodol in 1989 after finding it caused fatal liver disease, the UK and other countries already selling the drug then banned it.