Over-reaching FDA regulations have caused the premature deaths of millions of Americans, according to research scientist Mary J. Ruwart, Ph.D., who also said federal regulations passed in 1962 are responsible for more than 80 percent of the cost of today’s prescription drugs.
Ruwart, who is senior instructor with Burnet, Texas-based Sci-Com and adjunct associate professor of biology at the University of North Carolina in Charlotte, presented her findings on November 8 before the 2004 annual meeting of the American Association of Pharmaceutical Sciences in Baltimore, Maryland.
Instead of protecting Americans from unsafe drugs, Ruwart said, “these particular regulations, the 1962 Kefauver-Harris Amendments, have proven to be more deadly than all of the drug toxicity that occurred before their passage.” She estimated that between 1963 and 1999, 4.7 million people died prematurely while the medicines that could have saved them languished in mandated testing.
“The amendments saved a few thousand lives, but the cost was [in] letting millions die [while] waiting for treatment. That’s why the amendments are ‘excess’ regulation,” Ruwart said.
Drug Development Time Tripled
The time it took to develop a new drug was stable, at about four-and-a-half years, for the two decades prior to passage of the Kefauver-Harris Amendments, said Ruwart. Since then, development times have soared. By the 1990s, the average drug spent more than 14 years in regulation-mandated testing and FDA review.
Spending on research and development has increased more rapidly than development times. Because patent protection for a drug begins at the R&D stage–not once the drug is actually approved for sale–manufacturers try to move through their R&D timelines as quickly as possible, giving them as much patent-protected time as possible to profit from the drug’s sale.
“What we spend for prescription drugs can be predicted by what manufacturers spend on R&D,” Ruwart said. “If pre-amendment trends had continued, drug prices [now] would be about 15 percent of what they are today. We’d have more innovation and twice as many drugs to choose from.” In addition, Ruwart noted, “Pharmaceuticals replace more expensive medical interventions like surgery, so that every dollar we spend on drugs lowers health care costs by $2-$3.”
“Excess regulation [also] discourages innovation and encourages copycats, by forcing manufacturers to shift R&D spending from research to development,” Ruwart said. “We might reverse this trend by eliminating excess regulation.”
Litigation Costs Also Excessive
“It is clear that FDA requirements significantly increase the cost of creating new drugs,” agreed Merrill Matthews Jr., Ph.D., director of the Council for Affordable Health Insurance. “However, FDA reform without tort reform would not gain us much.”
Matthews added, “The industry wants some regulation, to protect themselves. Even if all regulations were removed, however, I am guessing the industry would still incur 50 percent or 60 percent [of the expenses that make up today’s high prices] voluntarily, because they would want to make sure that the new products were safe and effective.
“The fact is that in the class action-happy society we live in, fueled as it is by unscrupulous trial lawyers, the drug industry wants and needs the liability protection that a time-consuming, expensive, and inefficient regulatory process provides,” Matthews said. “Removing those restrictions without limiting the trial lawyers will only result in a windfall to the plaintiff’s bar.”
Ruwart does not believe the FDA is to blame. “The FDA was told to enforce bad law,” she pointed 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 lifesaving medication or medical procedure,” Ruwart said. “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.”
Susan Konig ([email protected]) is managing editor of Health Care News.