Investigators with the Milwaukee Journal Sentinel and MedPage Today had a question. They wanted to know what happens after the Food and Drug Administration (FDA) sends out warning letters to doctors regarding some pretty grievous issues.
The answer? "Not much." When investigators looked at 73 cases involving doctors who had received FDA warning letters within a five-year span, they discovered that exactly one doctor had actually faced any consequences.
The FDA does not exactly regulate the practice of medicine. It does, however, have the power to look into issues where unsafe medical devices and drugs are potentially endangering the public. As a result, the agency has investigated a number of complaints regarding physician practices. Some of the situations the FDA had investigated included:
- A doctor who was testing an unapproved brain implant on patients to treat aneurysms and another implant designed to clear blood clots, both of which relied on research that wasn't compliant with federal regulations.
- Repeat problems with a doctor using unproven and dangerous vein-opening procedures on victims of multiple sclerosis.
- A physician hawking a $1,800 per month unproven "cure" for cancer
- A fertility clinic that didn't bother to test egg donors and sperm donors for sexually-transmitted diseases.
In all those cases (and others) the FDA issues "warning letters." However, those warning letters were sent only to the doctors themselves -- not the licensing boards in their respective states. Medical boards can obtain copies of the letters, but the process is not automatic.
Unfortunately for California physicians, many of the doctors highlighted in the article were located within the state. (That's not because there are any more "bad apples" among California physicians than elsewhere, but simply a reflection that the state has a larger percentage of physicians than other states.)
The bad press was considerable, and the California Medical Board took notice. Now, the Board is now actively looking into any letters sent by the FDA in the future (and, quite possibly, the recent past).
For California physicians, this is important information to note. The bad press means that the state Board is unlikely to be neither open-minded nor forgiving if there's a potential problem with a physician's practice.
Is your medical license in danger due to an FDA warning letter? Don't try to handle this issue on your own with the Board. An experienced attorney can help you navigate the troubled waters you are in.