Word: gao
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...pharmaceutical firms submitted to the Food and Drug Administration for potentially groundbreaking new drugs during that 10-year period increased only a meager 7%. And since 1995, the applications for these innovative drugs have been dropping each year. "The productivity of research and development investments has declined," the GAO concluded...
...Ironically, the shrinking pipeline comes at a time when basic science is bursting with new breakthroughs in fields like human genome decoding, which in turn have raised hopes for breakthrough cures and treatments of serious illnesses. But the numbers show otherwise. The GAO reviewed all 1,264 of the new drug applications submitted for FDA approval from 1993-2004 and found that 60% of them were actually for what industry analysts call "me too" drugs-variations of medications already out on the market. Only 12% of the applications were for what the FDA classified as "priority" new drugs-that...
...three Democrats who asked for the GAO study-Rep. Henry Waxman, Sen. Edward Kennedy and Sen. Richard Durbin-pounced on its findings as proof once more that corporate greed in health care is shortchanging consumers. "The report shows that much drug industry research doesn't translate into real breakthroughs for patients," says Kennedy. The Pharmaceutical Research and Manufacturers of America, which represents the drug industry, fired back that the GAO report only confirms that developing new drugs has become a more expensive, difficult and risky exercise for manufacturers. "Researchers are tackling increasingly complex diseases using new tools-such as genomics...
...business interests have actually been a factor in curbing innovations, the GAO found. During the past decade the pharmaceutical industry has tended to focus on "blockbuster drugs" for large patient populations that can generate as much as $1 billion in annual sales, while ignoring "other drugs for more limited populations that generate much less revenue." Manufacturers find "me too" drug development less risky and more potentially lucrative than research into brand-new medications. Drug company mergers in the early 1990s also have resulted in the larger firms' scaling back R&D into new drugs as they look to cut costs...
...GAO had the National Academy of Sciences convene a panel of 14 doctors, scientists, pharmaceutical industry researchers and patient advocates to come up with ways to spur innovation. They recommended more collaboration among government, industry and academia. Colleges, for example, could offer more scholarships to train translational researchers. The government could offer more incentives for innovative drug research. Patents for breakthrough drugs could be extended from the current 20 years to 25-30 years, while patents for "me too" drugs could be shortened to 10 years. Otherwise the billions for research will end up producing bigger profits, but not necessarily...