Regulation hampers the very medical innovations we need 

We all know that life is fragile, but the death of American Enterprise Institute economist Jack Calfee came as a shock. He was working away at his desk at home on the evening of Feb. 16, two weeks before his 70th birthday, and died of a heart attack.

Jack and I spent several years together at the American Enterprise Institute in the 1990s, and I saw him regularly thereafter. Jack worked on government regulation of pharmaceuticals and medical devices, how to speed their route to the consumer, how to increase innovation. He always had time to talk about his work and his family.

On the night he died, Jack was working on an article on medical devices that showed that although tightening requirements for medical devices might increase public safety, it would also hamper innovation.

Three weeks earlier, Jack had written an article published by AEI on medical devices as a treatment for heart failure. Little did he know that he would soon die of a heart attack.

Jack wrote that Food and Drug Administration approval of medical devices to reduce heart failure is far slower in America than in Canada and the European Union. The FDA has approved six models, whereas the European Union has approved 11, and development is faster in the EU.

“As a result,” Jack wrote, “further progress against heart failure depends not only on continued technical progress but also on changes in FDA policy that facilitate faster approval.”

Jack was also concerned about FDA regulation of pharmaceuticals slowing down the progress of these drugs to patients. Last December he described the negative effects of more stringent regulation of the diabetes drug Avandia, marketed by GlaxoSmithKline.

As America debates the future of health care, Jack’s work on the innovation of drugs and medical devices is of paramount importance. Pharmaceutical companies have been especially affected both by a slow FDA approval process and by lawsuits, reducing their rate of innovation.

On Jan. 14, Health and Human Services Department Secretary Kathleen Sebelius announced that the administration is stepping in to fill the gap, funding a $1 billion drug development center at the National Institutes of Health to discover new drugs.

This amount is tiny compared with the $45 billion pharmaceutical companies spend annually and it cannot replace private-sector innovation.

FDA’s attempts to increase access of terminally ill patients to new drugs are still complex enough to deter doctors and patients from accessing the drugs, and they place too much of a burden on FDA to approve individual situations. Only educated or lucky consumers have access to the newest drugs.

Benefits and costs of new drugs and devices differ by patient, and, being subjective, are best assessed by patients themselves. Some people may have significant side effects from a drug that others tolerate well.

Jack told me in one of our discussions back in 2006, “Let patients and doctors choose whether to use new drugs.” Since patients have very specific needs, and doctors have the most information, it makes sense for patients and doctors to make the decision.

If Jack were alive, I would have been able to call him to check that I’d quoted him correctly. But since he’s no longer with us, his voluminous work will have to speak for itself.

Examiner columnist Diana Furchtgott-Roth, former chief economist at the U.S. Department of Labor, is a senior fellow at the Hudson Institute.

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