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Although less than half of government funding for biomedical research is for clinical research (Note 1), another potential direct impact on the part of the government is via funding of clinical research on drugs, including sponsorship or cosponsorship of the clinical trials used for FDA approval. The various incentives offered by the Orphan Drug Act of 1983, and tax credits provided for research and development in general, represent other types of direct support that our analyses do not capture
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Although less than half of government funding for biomedical research is for clinical research (Note 1), another potential direct impact on the part of the government is via funding of clinical research on drugs, including sponsorship or cosponsorship of the clinical trials used for FDA approval. The various incentives offered by the Orphan Drug Act of 1983, and tax credits provided for research and development in general, represent other types of direct support that our analyses do not capture.
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Of the ninety-nine drugs without patents in the Orange Book, about one-fourth (twenty-three) were antibiotics of certain types that were not subject to the Orange Book regime until 2008. After these drugs are excluded, drugs without patents accounted for only 5 percent of sales reported in the Medical Expenditure Panel Survey (MEPS) in 2006, half of which came from one drug. The manufacturers of new drugs without patents rely solely on market exclusivity to recoup their investment
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Of the ninety-nine drugs without patents in the Orange Book, about one-fourth (twenty-three) were antibiotics of certain types that were not subject to the Orange Book regime until 2008. After these drugs are excluded, drugs without patents accounted for only 5 percent of sales reported in the Medical Expenditure Panel Survey (MEPS) in 2006, half of which came from one drug. The manufacturers of new drugs without patents rely solely on market exclusivity to recoup their investment.
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Many scholars, such as Carolyn Asbury, believe that public-sector research has traditionally played an especially prominent role in the de velopment of orphan drugs-drugs that target rare diseases. To investi gate this question, we looked sepa rately at drugs with and without or phan designations, as indicated at Drugs@FDA. About 16 percent (59 of 379) of the drugs in our sample were orphan drugs. These drugs were more likely to have NIH patents than nonorphans (24 percent versus 6 percent; p ≤ 0:01) and more likely to cite NIH patents or publications (66 percent versus 44 percent; p < 0:01). Asbury CH. Orphan drugs: medical versus market value. Lexington (MA): Lexington Books
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Many scholars, such as Carolyn Asbury, believe that public-sector research has traditionally played an especially prominent role in the de velopment of orphan drugs-drugs that target rare diseases. To investi gate this question, we looked sepa rately at drugs with and without or phan designations, as indicated at Drugs@FDA. About 16 percent (59 of 379) of the drugs in our sample were orphan drugs. These drugs were more likely to have NIH patents than nonorphans (24 percent versus 6 percent; p ≤ 0:01) and more likely to cite NIH patents or publications (66 percent versus 44 percent; p < 0:01). Asbury CH. Orphan drugs: medical versus market value. Lexington (MA): Lexington Books; 1985.
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Most of the drugs that we studied (324 of 379) had neither academic patents nor patents citing government funding. A handful (7) had NIH patents but not academic patents. And some (21) had no patents indicating government funding but did have academic patents
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Most of the drugs that we studied (324 of 379) had neither academic patents nor patents citing government funding. A handful (7) had NIH patents but not academic patents. And some (21) had no patents indicating government funding but did have academic patents.
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When Salomeh Keyhani and colleagues examined data on NIH funding of clinical trials, they found that the NIH role was much stronger with HIV drugs than other classes of drugs
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