American Elephants


Another Outstanding Appointment by President Trump by The Elephant's Child

President Trump has selected a physician who is a policy expert to run the Food and Drug Administration—which may be one of the toughest jobs in Washington. Dr. Gottleib served as a deputy commissioner at the FDA during the G.W. Bush Administration, and has worked at the Centers for Medicare and Medicaid Services. He is a resident fellow at the American Enterprise Institute and writes regularly on physician autonomy, drug prices, antibiotic development and more. In other words, he’s familiar with the problems. We’ll see if he can fix them.

One of Dr. Gottlieb’s priorities will be moving generic medicines to market, and competition is the best way to reduce the price of treatments like the now infamous EpiPen. About 10% of 1,300 branded drugs “have seen patents expire but still face zero generic competition,” Dr. Gottlieb wrote in the Journal last year. “New regulations have, in many cases, made it no longer economically viable for more than one generic firm to enter the market.” Now he can roll back such arbitrary directives.

Dr. Gottlieb has also suggested that the FDA should explain its reasoning when declining to approve a drug. FDA does not release a rejection notice known as a complete response letter. The rule ostensibly exists to protect manufacturers, but the silence allows the agency and a company to peddle divergent tales about what happened. The public is left with minimal information and FDA can operate without fear of accountability.

The need for new antibiotics is dire, and a bureaucracy overburdened with regulation and fearful of accountability is not the way to get things moving. The FDA has been overburdened with caution ever since the thalidomide scandal in the ’60s. Thalidomide was a tranquilizer, marketed as a mild sleeping pill safe even for pregnant women, but it turned out to cause thousands of babies to be born with malformed or missing limbs. Careful testing for safety is essential, but getting drugs to market to save lives is also important. Avoidance of accountability is not.

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