FDA FELLOWSHIP PROGRAM FOR NEW DRUG REVIEWERS MAY BE EXTENDED TO MEDICAL STUDENTS; TWO FDA CHEMISTS COMPLETE TWO MONTH RESIDENCY IN INDUSTRY

Executive Summary

FDA and the Pharmaceutical Manufacturers Association are discussing a fellowship program which would bring post-residency medical students to FDA. Under the proposed program, which PMA has offered to fund, students from Washington area medical schools would complete a year of training in epidemiology and clinical trial design at FDA in return for a commitment to spend the next few years as reviewers at the agency. The medical student proposal is one of a series of fellowship programs that FDA has considered as part of its effort to bring more resources to the new drug review process. PMA is also working with the American Medical Association to identify senior physicians to participate as fellows at FDA. The agency has long used staff fellowships as an appointment mechanism, but they are now being utilized more frequently. The use of a fellowship program to bring academic scientists to FDA was a specific proposal in the agency's recent Action Plan. As part of the fellowship program, two MDs from Children's Hospital in Washington have been working as medical reviewers for three days per week in the anti-infective drugs division since July. The Office of Drug Standards also employs staff fellows. FDA also recently sent two review chemists on two-month sabbaticals to industry as a pilot residency program. The two-month sabbaticals were completed Nov. 21. Joseph Sieczkowski, PhD, from the Oncology & Radiopharmaceutical Division, and Guirag Poochikian, PhD, from the Surgical-Dental Division were residents at Roche and Merck, respectively. The residency program grew out of the onging dialog between FDA and PMA on ways to improve the drug approval process. HHS Secretary Bowen endorsed the PMA-proposed program at the association's annual meeting in April ("The Pink Sheet" April 14, p. 12). Sieczkowski said the residency was intended to provide FDA review chemists with a first-hand understanding of the NDA preparation process. He noted that FDA may consider extending the program to toxicology and medical reviewers. FDA Commissioner Young gave an update on the Action Plan, at a press briefing Nov. 24. In a handout on the status of the plan, the agency noted that in October it completed its evaluation of an electronic NDA pilot program that compared review of a standard NDA submission with review through electronic access to clinical data. The first two electronic NDAs, submitted by Abbott under an agreement with United Medical, were for the cardiovascular drugs Cartrol (carteolol) and Vasocard (terazosin). Additional electronic applications are currently pending at the agency. In a discussion of FDA's progress in reviewing drug applications, FDA Office of Drug Research & Review Director Robert Temple, MD, noted that the backlog of supplemental NDAs has been reduced from 169 to 113 since last March. Temple said that in March the agency set "a very modest goal" of reducing the number of supplemental NDAs pending longer than 180 days by 20% over the next twelve months. In fact, he said, FDA has eliminated about 33% of the backlog and expects to have reduced the number by 50% as of March 1987. FDA and PMA have discussed ways of reducing the number of NDA supplements in the new drug evaluation process ("The Pink Sheet" Sept. 8, p. 3). Asked if the agency had any plans to transfer the review of supplemental applications to the generics division, Commissioner Young responded: "No, not supplements, per se, at this time. We feel that, as we've got the program underway now, we will be able to clean up the backlog on the efficacy supplements." Young indicated that FDA is considering a change in the method of reviewing label and chemical supplements. "We're exploring that, but there's nothing underway in the immediate future that would give rise to that."