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SPONSORS OF EXPEDITED DRUG APPROVAL CANDIDATES

Executive Summary

SPONSORS OF EXPEDITED DRUG APPROVAL CANDIDATES should use prudence in setting up early consultations with the agency, FDA Commissioner Young stressed at a Nov. 17 seminar: "Recent Changes in the FDA Drug Approval Process for Drugs and Biologics" sponsored by Prentice Hall Law & Business. "One way to help us fail is to abuse the opportunity for conferences," Young said. Young focused on the need for cooperation between drug sponsors and the agency on early conferences in order to ensure the success of the plan for accelerating approvals for drugs to treat life-threatening diseases. "It is extraordinarily important in establishing a relationship that you ask a question or ask for a conference when its important to have one," Young stated. Conferences will continue if the participants are serious about them, Young continued. "One frivolous conference, that's our mistake. Two frivolous conferences, that's your mistake and there won't be a third conference." He explained that by serious he means "that you feel in your heart of hearts that you've got a very important drug. That it's a drug that could be helpful for the desperately ill and that there's a genuine interest to really try to get agency advice and work with the agency." Young pointed out that he will not hold a conference without the CEO of the company there. "I expect the lead people, as well as the people in the trenches" to attend, he stated. FDA Center for Drug Evaluation and Research Deputy Director Gerald Meyer noted, in a separate presentation, that the agency is learning from the experience of the Anti-Viral Drugs Division that "early consultation has a place." FDA believes that the increased investment that the division is "making to sponsors of INDs should mean we are shifting some of the review workload to the front end of that process rather than leaving it until we get an application," he added. "If that's going to work right, and I think it has ... then we ought to get an application that is better." Meyer noted that activity in the area of Treatment INDs "is not overwhelming" and "would not generate anything in the way of resources." The volume of applications has actually slowed down, Meyers reported - of 16 Treatment IND applications submitted, "11 were received in the first nine months and only five [were] received in the next 10 months." He noted that 10 of those applications are for cancer and AIDS drugs. In discussing the current resource situations in some of CDER's review divisions, Meyer noted that the Division of Cardio-Renal Drugs could use some help, but that recruitment is difficult in the cardiovascular areas because of pay differences from the private sector. Meyer said that he was amazed that division director Raymond Lipicky, MD, made a commitment at the start of the year to reduce his overdue NDAs by 50%, which resulted in "the most tremendous increase in NCEs from anybody all at once in the last six or eight months." In contrast, the director of the Anti-Viral Division, Ellen Cooper, MD, is "extraordinarily successful at recruiting," Meyer said. "We get a lot of expressions of interest in working in Ellen's division and certainly some part of that says everybody wants to work on AIDS right now."
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