When the Udall authorization Bill became an amendment to the Labor, Health and Human Services General Appropriations Bill for fiscal 1998, a related amendment was inserted. The latter was a request, originated by Senators Bill Frist and Dan Coats, that the Institute of Medicine (IOM) review how research priorities are set and research funds allocated in the NIH and report back to Congress with recommendations for improvement. Senator Frist, an M.D., is Chairman of the Senate Subcommittee on Public Health and Safety and had been working on an NIH reauthorization bill. The IOM reported its findings and recommendations in July of this year in a document "Scientific Opportunities and Public Needs: Improving Priority Setting and Public Input at NIH". The report is full of issues which I think deserve to be addressed by people who are seriously concerned with PD funding. The report may be purchased from the National Academy of Science Press (1-800-624-6242), and it can also be viewed and/or downloaded without charge via the National Academy of Science web site www.nap.edu/readingroom. In the hope of stimulating some interest in and responses to the report, I will summarize and comment on a few of the points it raises. I hope I will be forgiven if at this point I oversimplify anything. The report describes the NIH funding context in which the Udall Bill effort took place, with specific references to the bill itself. It also recommends avoiding disease-specific funding legislation and proposes other mechanisms than Congressional disease-specific bills through which disease-specific funding requests may be channeled in the future. The report refers to the NIH booklet "Setting Research Priorities" (www.nih.gov/news/ResPriority/priority.htm) used by NIH in its funding decisions. I found an excellent summary in Dr. Varmus' statement before the Subcommittee on Public Health and Safety of May 1, 1997 (www.nci.gov/legis/varmus2.html). One of a number of criteria is "public health needs," as indicated for a disease by the number of people who have it, the number of people who die from it, the degree of disability it causes, the degree to which it shortens a normal, productive life, the economic and social costs, and the degree to which it may spread. A major point in the report is that the NIH does not make adequate use of disease burden data in setting priorities. The IOM accepts all the criteria put forth by the NIH, but notes that, especially in regard to meeting public health needs, the NIH has no systematic method of applying the criteria. Data on the above named public health indicators is not gathered or analyzed sufficiently, nor is there any written justification of funding level in terms of these indicators using the data that does exist. It is not apparent just how the NIH uses its own criteria. IOM recommends a greater effort in gathering and using disease burden data. Another point made in the report is the need for a mechanism to receive input from the public into the priority setting process and to resopnd to public concerns. To achieve this the IOM recommends creating a Public Liaison Office and a council of public representatives, and creating public memberships in the existing NIH advisory groups. These channels of communication are proposed as a preferable altenative to appeals to Congress, which should be made only as a last resort. After reading the report I have the following questions: * Will the IOM recommendations be taken seriously by Congress? * If so, is there a chance that the IOM recommendations will cause Congress to not make appropriations for the Udall Bill? * In the light of this plus the unpopularity in Congressional leadership circles of disease-specific legislation, does a stronger case need to be made that addressing PD funding in the Udall bill is justified as a last-resort measure due to a history of NIH not providing sufficient funds? * Senator Frist is working on a NIH reauthorization bill. Can we expect to see many of the IOM recommendations incorporated into this? * What should the criteria for priorities be? * How would the recommended communication channels work in practice? Phil Tompkins Hoboken NJ 60/9