A piece of investigative journalism out of Milwaukee is having an effect on the Medical Board in California. The Board is now going to start monitoring the warning letters the United States Food and Drug Administration (FDA) sends to doctors when there are concerns about practices that could be harmful to patients.
A recent investigation by The Journal Sentinel and MedPage Today found that there’s a big gap in communication between the FDA and the state medical boards that hold power over a physician’s license.
The FDA does not have the authority to discipline a physician for questionable or negligent practices. The agency will issue warning letters if it finds a serious problem and potential violation of federal regulations during an inspection at a doctor’s office, clinic or hospital. When patients are put at risk, the FDA will issue a warning letter to a doctor.
For example, warning letters were issued to doctors over the following circumstances:
- A fertility clinic didn’t bother to test donors of biological material (sperm and eggs) for communicable diseases.
- A doctor peddled a mix of supplements to patients as a sort of cure-all — even though the concoction isn’t recognized as a legitimate medication.
- A radiologist let his unqualified technicians handle mammograms without any quality controls in place.
However, these warning letters have always gone straight to the doctor in question — not the medical board. In the last five years, out of 78 warning letters issued by the FDA, only one doctor was disciplined.
The California Medical Board noticed that the report included several physicians within the state — which makes sense; California has more physicians than any other state. Now, doctors can no longer essentially ignore a letter from the FDA about its concerns — because the Medical Board will also be asking questions.
While most physicians would agree that this is a good thing that will protect patients against a few outliers in the field, there are bound to be some doctors who are unfairly warned. That could put an innocent physician in the crosshairs of an investigation.
In addition, the public nature of the news report all-but guarantees that the California Medical Board will be particularly touch-sensitive about potential problems with a physician. Every physician in the state needs to take note — and act accordingly. Failing to do so could put your professional license at risk.