FDA chief talks on drug availability

Keith Huebsch When it comes to life threatening diseases, inaction is the most dangerous path the Food and Drug Administration can follow, FDA Commissioner David Kessler said yesterday. Kessler, speaking to more than 100 people at Dunlop Auditorium yesterday afternoon, said he has been pressured by AIDS activists and cancer patients to accelerate the approval of new drugs to combat the illnesses. "Patients with serious and life-threatening diseases have told us over the last several years that they do not have the time to wait for us to dot every 'i' and cross every 't'," Kessler said. "They told us they wanted to make more of their own choices." So far, there have been no problems with drugs rushed through the approval process, he added. But the FDA may eventually come across a scenario where it would be forced to revoke a drug's approval status if it does not work or is found to be unsafe, Kessler said. The crowd was shocked when a 10-year-old questioned Kessler about patient willingness to take experimental drugs. The youth, Adam Schwartz, said he needed the information for a current events project for school. And he said he was genuinely interested in the search for cures to existing diseases such as AIDS. In response to Schwartz's question, Kessler said patients who are educated about the new drugs will usually submit to the experimental treatment even though there is less information. "You have to take the risks," Kessler said. "You can't have all the answers. You can't have it both ways." The commissioner, who is also leading a fight against cigarette smoking, said the FDA will continue to sacrifice knowledge about the safety and benefits of drugs in order to bring them to the market faster and perhaps save lives in the process. In recent months, the policy has led some AIDS groups to urge the FDA to be more cautious in drug approval and testing procedures, though, he added. "The dying patient today may feel that he or she has nothing to lose by trying the drug," Kessler said. "We have to strike a balance in giving the patients access to the drugs and following through on the studies." Wharton graduate student Jonathan Foster said Kessler outlined a strong argument for current FDA policies. "I was impressed that [Kessler] presented a very thoughtful and methodical approach to the subject," Foster said. "He seemed to recognize the realities of the situation." Kessler was the first speaker in the Leonard Davis Institute's Center for Health Policy Charles C. Leighton Memorial Lecture Series. The speech was sponsored by the world's largest pharmaceutical manufacturer, the Merck Company Foundation.