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December 8, 2016

Reining In The Overreaching FDA

  Investor's Business Daily

President-elect Donald Trump has promised to scale back burdensome federal agencies, regulators and regulations. A good place to begin is with naming a new person to head the U.S. Food and Drug Administration. Both Dr. Scott Gottlieb, a former FDA deputy commissioner, and Jim O'Neill, a former principal associate deputy secretary at the Department of Health and Human Services, have been mentioned as candidates.

The FDA has a broad mandate to protect "the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation."

But like most federal agencies it has gone overboard, often spending time on useless projects, limiting access to needed products, and persecuting — if not prosecuting —those exercising their free speech rights.

Take popcorn, for example. The New York Times reports that in 2010, the FDA pushed the Obama administration to include in the Affordable Care Act a provision requiring movie theaters to post the calorie counts of popcorn.  The agency wanted people to know that a bucket of popcorn had more calories than two Big Macs — as if people willing to pay $10 for popcorn really cared.

In this case the administration wisely pushed back, thinking that Obamacare critics would have a field day ridiculing such a provision. The Times describes a "chilly" conversation between an administration official and the FDA commissioner, but the FDA relented and withdrew its demand.

Not so with the FDA's recent attempt to essentially wipe out antibacterial hand soaps. That's right, the antibacterial products that millions of Americans use multiple times every day.

The FDA announced in September its intention to ban 19 active ingredients in hand soaps, effectively eliminating consumers' access to these products. The agency was forced into taking action by a lawsuit initiated by the National Resources Defense Council, which seeks to end the use of certain ingredients in antibacterial products because it thinks those products can be harmful to humans and lead to a resistance to the chemicals.

But controlled studies have indicated just the opposite. A 2011 study in the International Journal of Microbiology Research concluded, "This (study) adds to and confirms previous yet limited community data showing lack of evidence that the use of antibacterial wash products facilitates antibiotic resistance and antibiotic/antibacterial cross-resistance."

While overuse of antibiotics leads to a growing resistance, antibacterials do not appear to have the same result.

In announcing its final decision, the FDA stated that consumers can just use plain soap and water. However, this advice ignores studies that show antibacterials provide greater germ-fighting protection and reduce the spread of harmful bacteria that lead to foodborne illnesses.

Ironically, the FDA's ruling potentially compromises consumer health and safety in defiance of its own stated mission of protecting public health.

A third example is the FDA overreach is its campaign against free speech. The FDA must approve the safety and efficacy of new prescription drugs before they can be sold in the United States.  Those approvals are for treating specific conditions. However, many doctors use FDA approved drugs "off-label," meaning for a purpose or in doses not specifically approved. The practice is fairly widespread, especially among certain diseases such as cancer.

The medical community learns from those off-label practices and adopts them if they work. In addition, scientific studies are often conducted on off-label use, demonstrating safety and efficacy.

But the FDA has long fought any effort by drug company representatives to mention those off-label findings to doctors — what the FDA calls "misbranding" — even when the results were published in major medical publications. As a result, some pharmaceutical companies filed suit, and they have been winning in the courts.

The Hill contributor Joseph Gulfo noted last year, "The courts ruled that the First Amendment protects drug manufacturers provided that their communications are truthful and not misleading, whether or not the use has been approved by the FDA."

Even so, the FDA hasn't conceded the point yet. It held a public forum in New York in Novemberto hear from both sides. Whether or not off-label use is a good thing is a medical issue, but the notion that a health care representative talking with a doctor is precluded from citing public information is a constitutional issue. And the Constitution should win.

The FDA has a broad mandate and it has often been a force for good. But like any bureaucracy it can overreach or get sidetracked. President-elect Trump can get the agency back on track by naming the right commissioner who will return the agency to its limited but important role.


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