Acting FDA chief expected to speed drug approvals

Washington -- If the new acting Food and Drug Administration commissioner has his way, the agency would get potentially lifesaving medications from the bench to the bedside much more quickly than it does now. That's the perception of many agency watchers, but some consumer advocates say such a push would be inappropriate for an agency under fire.

Late last month, President Bush named Andrew C. von Eschenbach, MD, to the post after the unexpected resignation of Lester Crawford, DVM, PhD, who left his position less than three months after receiving Senate confirmation. Dr. von Eschenbach will continue to hold his title as director of the National Cancer Institute.

Since taking the NCI helm in 2002, Dr. von Eschenbach has made its focus reducing cancer from a life-ending illness to a manageable chronic condition by the year 2015. Integral to this goal is an aggressive timetable for moving oncology drugs out of the testing phase and into physicians' reach.

"At the end of 2002, there were 100 new cancer drugs in the Phase III stage of clinical trials testing," he said soon after unveiling the 2015 agenda. "But given that only a handful of drugs receive FDA approval every year, it's obvious we need to do what we can to improve the process."

The prospect that this sense of expediency will accompany Dr. von Eschenbach to his new job has cheered the prescription drug industry.

"The administration has moved quickly and placed the Food and Drug Administration in good hands, allowing the FDA to move forward on a number of important issues," stated Pharmaceutical Research and Manufacturers of America President and CEO Billy Tauzin.

Particularly encouraging to the industry is Dr. von Eschenbach's commitment to the FDA's "Critical Path" initiative, a project that the agency launched in 2004 to address recent slowdowns in the medical product approval process. Drug makers expect that the acting director will push very hard to continue this work, which is expected eventually to mean more efficient clinical trials, said Alan Goldhammer, PhD, PhRMA's vice president for scientific and regulatory affairs.

But doctors on the lookout for therapies under development shouldn't expect an immediate, major shift in the pace of approvals, Dr. Goldhammer said. Most day-to-day approvals and safety review processes of the agency are directed by veteran, staff-level regulators whose short-term goals are not altered by the commissioner, whether acting or not.

Experts following the FDA also predict that Dr. von Eschenbach will involve the patient community and physicians in the agency's decision-making process to a larger extent than usual. His experience of trying to fast-track approvals of cancer drugs whose illness-fighting potential appears to outweigh their risks will be evident in the new position, said Chris Milne, DVM, assistant director of the Tufts Center for the Study of Drug Development in Boston. The fact that Dr. von Eschenbach is a three-time cancer survivor could make him more sympathetic to these patients and their doctors, Dr. Milne said.

"He'll listen to the patient advocate groups as far as wanting to lean on the side of access of drugs to patients," he said. "You will probably begin to see some widening of the risk-benefit threshold because of that."

Doctors treating cancer patients would support such reforms, says the American Society of Clinical Oncology. A recent ASCO policy paper states that "for many cancers, the best and perhaps only available therapy may be one that involves real, unavoidable and potentially life-threatening toxicity."

Dr. von Eschenbach could not be reached for comment.

Worries about safety, conflicts

Not everyone is happy about Dr. von Eschenbach's stance on drug approvals. With the agency reeling from recent high-profile cases involving safety issues with painkillers, heart devices and the use of psychiatric drugs on children, some say he is the wrong person to take over the agency at this time.

"He is somebody far too eager to bring drugs, particularly new cancer drugs, onto the market," said Peter Lurie, MD, deputy director of the health research group at the consumer rights group Public Citizen. "That might lead to a lowering of standards at the FDA, and that is the last thing we need right now, given the shoddy state of affairs at the agency."

Dr. Milne said Dr. von Eschenbach is at risk of running into opposition from safety advocates if he tries to implement any long-term liberalization of FDA approval standards. Agency critics will be more attuned to potential medical problems that could arise from rushing therapies through research and development, he said.

Some on Capitol Hill also have questioned the commitment and agenda that the acting FDA commissioner might bring to the job. Senate Finance Committee Chair Charles Grassley (R, Iowa) and Senate Health, Education, Labor and Pensions ranking member Edward Kennedy (D, Mass.) said the appointee would have great difficulty trying to juggle the demands of both the NCI and the FDA jobs.

Moreover, said Kennedy and others, Dr. von Eschenbach cannot in good faith run both shops and avoid ethical entanglements. "There are intrinsic conflicts of interest between the role of NCI director, who manages a research program that includes drug development, and the role of FDA commissioner," Kennedy said in a letter to the Bush administration.

That outcry quickly prompted Dr. von Eschenbach to announce that he temporarily would relinquish the day-to-day duties of running the cancer institute and recuse himself from any FDA business in which the NCI is a party.

Dr. von Eschenbach was thoroughly vetted by the White House when he was under consideration for the NCI job, but this process might prove more extensive if Bush were to nominate him for the permanent FDA post.