Austin, TX (PRWEB) November 9, 2004 -
ÂRegulations passed in 1962 are responsible for over 80% of todayÂs drug pricesÂ says research scientist Dr. Mary J. Ruwart, Senior Instructor with Sci-Com, Burnet, TX and Adjunct Associate Professor of Biology at the University of North Carolina in Charlotte. In her November 8th presentation at the 2004 Annual Meeting of the American Association of Pharmaceutical Sciences, Dr. Ruwart presented data suggesting that these regulations have caused the premature deaths of millions of people by slowing development of life-saving medications and thwarting innovation.
Development times, about 4-1/2 years long, were stable for the two decades prior to the 1962 Kefauver-Harris Amendments. Since then, development times have soared. By the 1990s, the average drug spent over 14 years in regulation-mandated testing and FDA review.
R&D outlays have increased somewhat more rapidly than development times, as manufacturers try to com-press time lines to preserve patent life. ÂWhat we spend for prescription drugs can be predicted by what manufacturers spend on R&D,Â Dr. Ruwart explains. ÂIf pre-amendment trends had continued, drug prices would be about 15% of what they are today. WeÂd have more innovation and twice as many drugs to choose from. Pharmaceuticals replace more expensive medical interventions like surgery, so that every dollar we spend on drugs lowers health care costs by $2-$3.Â
Do we need more pharmaceuticals when so many are Âme-tooÂ drugs? ÂExcess regulation discourages inno-vation and encourages copy-cats by forcing manufacturers to shift R&D spending from research to develop-ment,Â Dr. Ruwart points out. ÂWeÂd reverse this trend, at least in part, by eliminating excess regulation.Â
But donÂt regulations protect Americans from unsafe drugs? ÂThese particular regulations, the 1962 amend-ments, have proven to be more deadly than all of the drug toxicity that occurred before their passage,Â Dr. Ruwart claims. She estimates that between 1963 and 1999, 4.7 million people died prematurely while the medicine which could have saved them languished in mandated testing. ÂThe amendments saved a few thousand lives, but the cost was letting millions die waiting for treatment. ThatÂs why the amendments are ÂexcessÂ regulation,Â Dr. Ruwart explains.
Should those upset about high pharmaceutical prices and development delays blame the FDA? Dr. Ruwart doesnÂt think so. ÂThe FDA was told to enforce bad law,Â she points out. ÂThe good people there, some of whom IÂve worked with, were put in a very difficult situation.Â
ÂBefore we are regulators, legislators, members of the pharmaceutical industry, or cost-conscious consumers, we are all human beings who will one day need a life-saving medication or medical procedure,Â Dr. Ruwart contends. ÂFor all of our sakes, the national debate on high pharmaceutical prices and affordable health care should include a thorough examination of the costs of excess regulation.Â
Mary J. Ruwart, Ph.D.
Full presentation: http://www.ruwart.com/AAPS.pdf