The drug approval process

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TASK FORCE 6 The Drug Approval Process GOLDBERG (Chairman) BELTON KOHLSTAEDT PELTIER (Co-chairman) CHRISTENSEN SAUNDERS CROUT (Co-chairman) COVINO SCHIFFRIN A. Improvement of IND/NDA Process 1. We recommend that increased attention be di- rected toward planning and protocol review during the investigational new drug (IND) phase rather than detailed review of the new drug application once it is completed and submitted. 2. We recommend that a separate review mecha- nism be developed for drugs intended for marketing and that during their investigational phase data on these drugs be submitted in a new format known as Developing New Drug Applications (DNDAs). 3. We propose that clinical and laboratory data developed during the investigational phase of such new drugs be submitted and reviewed sequentially in the form of a Phase I DNDA, a Phase II DNDA, and finally a Phase III DNDA. Approval of this final seg- ment of the DNDA series would be equivalent to ap- proval of the drug application. This system would eliminate duplicate submission of data and divide the review process into a logical sequence that would aid rational decision-making in both the industry and the FDA. 4. We recommend that the proposed prescribing information or product labeling be submitted in draft at the beginning of the Phase III DNDA to serve as a planning guide for clinical studies to be conducted during that phase. B. Recommendations for Improving the Labeling Process 1. The Task Force recognizes that a serious delay in the approval of new drug applications frequently occurs because of differences of opinion regarding ad- equacy of drug labeling. A sincere effort is recom- mended to improve the process in formulation of new drug labeling. In addition to the input of the FDA and industry, some representation from the medical profession should participate in the formulation of new drug labeling. 2. The Task Force recommends that the system of including information as package inserts be discon- tinued except for parenterally administered drugs which are used primarily in hospitals. The consensus was that physicians rarely see these package inserts. These are usually disposed of by pharmacists. As an alternative the Task Force recommended that it would be more appropriate that the prescribing in- formation on new drugs be sent out by manufacturers to all physicians when new drugs are announced. These circulars would contain no promotional infor- mation and would have the same legal status as the present package circular. The product information for physicians should be released in a standard form so that it could be filed in a notebook. These data should also be included in a compendium. 3. In addition, the Task Force suggested that it would be useful to provide product information for patients. It would not be necessary to prepare these data before release of the drug; nor would it be a pre- requisite of approval of an NDA. These product in- formation sheets would be available to enhance the physician-patient relation. 4. The Task Force suggested that consideration be given to an initial restrictive type of labeling in an ef- fort to expedite the approval of certain new drugs. After additional experience with such agents, label- ing should be reviewed, and, if warranted, the restric- tions modified. C. Approval of New Claims for Marketed Drugs 1. The group recognized that new uses for a drug often develop after the drug is marketed. The quality of information supporting such new uses varies great- ly. Research on new uses often occurs in foreign countries and also outside of the IND process in the United States. Thus, full case reports in support of new claims may not always be available. 2. We recommend that the FDA, industry and in- vestigators engage in collaborative efforts to bring such research under the IND process whenever possi- ble. 3. We also recommend that greater use be made of the medical literature in supporting new claims for marketed drugs. Full case reports should not neces- sarily be required to back up high quality trials pub- lished in well reviewed journals with strict scientific editorial policies. D. Postmarketing Investigations of New Drugs 1. When necessary to do such studies the Task Force recommends that epidemiologic consultants advise both the industry and the Food and Drug Ad- October 1,1974 The American Journal of CARDIOLOGY Volume 34 455 DRUG APPROVAL PROCESS-TASK FORCE 6 ministration as to the most appropriate design of studies to evaluate either safety or efficacy following early release of a new drug. If safety questions are at issue, reporting of adverse reaction is paramount. E. Recommendation for an Advisory Standing Committee 1. A Standing Committee should be appointed to consider issues in clinical pharmacology and thera- peutics in the cardiovascular area and to include members of the American College of Cardiology and the American Heart Association. The purpose of this committee would be to provide liaison between mem- bers of these organizations, the FDA, the pharmaceu- tical industry and the National Heart and Lung In- stitute. The functions of the committee might well include: 1. Stimulating research in cardiovascular drugs. 2. Developing criteria for efficacy in major areas of cardiovascular interest. 3. Considering quality of evidence. 4. Providing editorial reviews of drug therapy. 488 October 1, 1974 The American Journal of CARDIOLOGY Volume 34