Semi-OT--FDA Deputy Director Lumpkin Outlines Agency's Challenges
By MELANIE TROTTMAN
Dow Jones Newswires
NEW YORK -- The Food and Drug Administration faces a "very challenging time" as it seeks to keep pace with the abundance of new product candidates nearing review, said Dr. Murray Lumpkin, deputy director of the FDA's Center for Drug Evaluation and Research.
The FDA, Lumpkin said, needs to be properly prepared to meet the demand of expediting drug development without compromising the agency's high standards.
But, Lumpkin noted, the FDA's resources are not unlimited.
"Even though we look at ourselves as a can-do organization, we cannot do everything," Lumpkin told a group of investors and drug company executives at the Warburg Dillon Read Global Life Sciences conference here Thursday. The influx of new drug applications, while posing a challenge, is also creating excitement at the FDA, he said.
"The quality of the applications that come in is increasingly better than what it was in the past," Lumpkin said. "We do have the desire to get beneficial drugs available to patients as quickly as possible."
Determining that a drug is beneficial means the agency must reasonably conclude there is a positive benefit/risk profile. Risk-detection in the pre-approval life of a drug can be difficult, in part because the population studied in clinical trials may not fully reflect the population that will use the product, Lumpkin said. The number of patients involved in clinical trials is often substantially less than the population that will use the drug after its approval.
Consider, Lumpkin said, a drug that adversely impacts one in 50,000 patients. "You're not going to pick (the risk) up in a clinical trial setting," Lumpkin said, adding that the FDA is more likely to detect a risk profile of one in 500 or one in 1,000.
A key question is whether the public is willing to pay the price for a higher level of safety assurance. That would involve more money and larger clinical trials, Lumpkin said. Another pressing question is whether the majority should be penalized for the protection of a few.
The challenges the FDA is particularly concerned about involve ethical standards, clinical data integrity, and conflicts of interest between clinical trial sponsors and investigators. For example, a physician who is conducting a clinical trial for a company may be slated to receive a stock incentive if the drug becomes a product, Lumpkin told Dow Jones Newswires in a brief interview following his presentation. The agency, he said, recently imposed a financial-disclosure requirement in which clinical trial sponsors and investigators must reveal certain financial aspects of their relationship, Lumpkin noted.
Global standards are also an issue as the FDA seeks to create a global harmonization of technical requirements for drug approval. Currently, certain drugs available overseas haven't been approved in the U.S., which in some cases is a good thing, Lumpkin said. Still, "I think that that is something that we are concerned about," he added.
The needs of children, pregnant women and the elderly pose another area of concern for the agency. Facilitating the availability of good drugs is much like a balancing act, Lumpkin said, stressing that it's crucial to maintain consumer confidence in the system.
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I found it interesting that in the LB report (thanks PB) they called the FDA a "black box".
Jim |
