The Government Accountability Office has released a report on factors that hamper the development of new pharmaceuticals in the United States. According to the report, while pharmaceutical industry spending (adjusted for inflation) increased by 147 percent from 1993 to 2004, the number of new drug applications annually submitted to the Food and Drug Administration increased by only 38 percent. The increase was much smaller (7 percent) for drugs that represent new molecular entities; the annual number of new molecular entities reviewed by the FDA has actually fallen since 1995. Among those factors limiting the pipeline for new drugs are technical and regulatory difficulties in translating laboratory findings into human applications; the economic and business climate in which many industry decisions are made; an insufficient number of physician investigators knowledgeable about drug development; and a climate of secrecy and concerns about "certain intellectual property protections" that prevent learning from mistakes.

Among the sources cited by the GAO in its analysis is a report jointly produced by the AAMC and FDA in 2005 that examined the critical interface between academic institutions and industry as related to drug discovery. David Korn, M.D., senior vice president, AAMC Division of Biomedical and Health Sciences Research, served as a co-organizer and member of the expert panel convened by the AAMC and the FDA and was the co-editor of the resulting report, which is available at: http://www.aamc.org/drugdevelopmentscience. For more information, please visit the website.