Is Excess Regulation to Blame for Soaring Pharmaceutical Prices?

Share Article

Â?Regulations passed in 1962 are responsible for over 80% of todayÂ?s 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.

“Regulations passed in 1962 are responsible for over 80% of today’s drug prices” 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. “What we spend for prescription drugs can be predicted by what manufacturers spend on R&D,” Dr. Ruwart explains. “If pre-amendment trends had continued, drug prices would be about 15% of what they are today. We’d 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.”

Do we need more pharmaceuticals when so many are “me-too” drugs? “Excess regulation discourages inno-vation and encourages copy-cats by forcing manufacturers to shift R&D spending from research to develop-ment,” Dr. Ruwart points out. “We’d reverse this trend, at least in part, by eliminating excess regulation.”

But don’t regulations protect Americans from unsafe drugs? “These particular regulations, the 1962 amend-ments, have proven to be more deadly than all of the drug toxicity that occurred before their passage,” 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. “The amendments saved a few thousand lives, but the cost was letting millions die waiting for treatment. That’s why the amendments are ‘excess’ regulation,” Dr. Ruwart explains.

Should those upset about high pharmaceutical prices and development delays blame the FDA? Dr. Ruwart doesn’t think so. “The FDA was told to enforce bad law,” she points out. “The good people there, some of whom I’ve worked with, were put in a very difficult situation.”

“Before 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,” Dr. Ruwart contends. “For 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.”

CONTACT INFORMATION:

Mary J. Ruwart, Ph.D.    

Phone/fax: 1-888-570-5786

Full presentation: http://www.ruwart.com/AAPS.pdf

###

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Mary Ruwart
Sci-Com
888-570-5786
Email >
Visit website