Calif. Medical Board Begins Tracking Docs' FDA Warning Letters

Updated: Dec 23, 2018

An investigation found that 73 physicians around the country with active medical licenses had been the subject of FDA warning letters alleging serious problems over a five-year period, but only one had been disciplined.

The warnings involved fertility clinics that didn't test donors of eggs and sperm for communicable diseases; researchers who didn't follow rules designed to protect patients who volunteer for trials of drugs and devices; physicians who pushed dubious treatments and supplements to unwitting customers; and a mammography clinic faulted for inadequate quality control testing.

The Journal Sentinel/MedPage Today series examined many aspects of the broken world of physician discipline. The warning letter story focused on how physicians engaged in questionable behavior can fall through regulatory cracks. For instance, the FDA does not have the authority to discipline physicians or regulate the practice of medicine. It is limited to regulating products under the federal Food, Drug, and Cosmetic Act.

Meanwhile, the job of investigating and disciplining physicians is left to state medical boards. Yet the two sides do not regularly communicate.

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