Morning Briefing
Summaries of health policy coverage from major news organizations
Judge Deals Major Blow To Burgeoning Stem Cell Industry With Ruling That FDA Can Regulate Eye Treatment
A federal judge on Monday struck a blow against the rapidly growing stem cell industry, ruling for the Food and Drug Administration in its efforts to halt treatments by U.S. Stem Cell, a clinic in Sunrise, Fla., that blinded three patients by injecting a fat extract into their eyes. The decision does not shut down the clinic but states that the F.D.A. has the authority to regulate it and is entitled to an injunction against it. The judge, Ursula Ungaro of United States District Court for the Southern District of Florida, is expected to issue a further ruling shortly that will specify what action can be taken against the clinic. (Grady, 6/3)
Judge Ursula Ungaro agreed that the FDA has the authority to regulate a procedure that has become widespread in the burgeoning industry — using patients’ fat to create a stem cell treatment. The judge ruled that the FDA is entitled to an injunction ordering U.S. Stem Cell to halt the procedure. The judgment represents a major victory for the government, which has increasingly tried to constrain the industry even as it has rapidly expanded in recent years. (Wan and McGinley, 6/3)
In other news from the FDA —
The Food and Drug Administration found substantial levels of a worrisome class of nonstick, stain-resistant industrial compounds in some grocery store meats and seafood and in off-the-shelf chocolate cake, according to FDA researchers. The FDA's food-test results are likely to heighten complaints by states and public health groups that President Donald Trump's administration is not acting fast enough or firmly enough to start regulating the manmade compounds. (Knickmeyer, Flesher and Casey, 6/3)
