Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was a featured guest on WBUR, in “Why Congress Quietly Just Gave the FDA More Power,” by Claire Donnelly and Meghna Chakrabarti.

Following is an excerpt:

Congress recently, and quietly, gave the FDA the power to prohibit off-label uses of medical devices. …
But others say the new authority allows the FDA to interfere with the physician-patient relationship.
They're also concerned that the power could extend to prohibiting off label use of prescription drugs.
"That’s truly arrogant to think that the federal government is the one and only one who knows better than the physicians at the state boards of medicine about what good medicine is or what it isn’t," Brad Thompson says.
Today, On Point: Why Congress quietly just gave the FDA more power.

  • Zachary Brennan, senior editor at Endpoints News, where he covers the U.S. regulatory agency.
  • Randall Stafford, professor of medicine at the Stanford School of Medicine.
  • Brad Thompson, attorney at the firm Epstein Becker Green who counsels medical device and drug product companies on FDA regulatory issues. …

On FDA power to sell off-label devices
Brad Thompson: "I think one thing that we probably all auto agree on is that FDA has very strong control over the manufacturers and how they promote these products. They have the power during the approval process to define exactly what the label can say, what is on label. And then through their enforcement mechanisms, they have the ability to control really anything and everything that the manufacturer does in order to promote the product.
"And some of the biggest fines paid by drug and device companies have been for when they mess up and they promote something for an off-label use. There are literally hundreds of cases of such enforcement and the companies have to pay massive fines. So there really is no freedom here on behalf of the companies when it comes to these off label uses. The only issue is how folks who buy them can use them."

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