California Medical Board Begins Tracking Doc’s FDA Warning Letters
Action follows MedPage Today/Milwaukee Journal Sentinel investigation
By John Fauber, Milwaukee Journal Sentinel and MedPage Today
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 story highlighted the cases of several physicians with California licenses who had received warning letters.
In response to the inquiries from the news organizations, the California board began getting the warning letters, said spokesman Carlos Villatoro.
“The Board reviews the letters and if they contain information regarding physicians licensed by the Board, the Board looks into the matter,” he said in a recent email. The practice began in June, but only now is being confirmed.
With nearly 150,000 physicians, California has more physicians than any other state. The next closest is New York with 94,000.
It is unclear whether other state medical boards have taken similar steps.
In response to the investigation, the FDA also is taking action. A spokeswoman said the agency may start notifying state boards of potential patient safety issues raised in its letters, at least on a case-by-case basis.
“We do intend to conduct outreach to state healthcare practitioner and pharmacy licensing boards to remind them about our public warning letter database and encourage them to sign up for our email updates,” spokeswoman Stephanie Caccomo said in a statement.
Michael Carome, MD, who heads the watchdog group Public Citizen’s healthcare division, applauded efforts to ensure that physicians named in the letters are brought to the attention of their state medical boards.
“It is a positive step to protect patients who might be put in harm’s way,” he said.
He said that is especially important, because there is no requirement that the letters be sent to the National Practitioner Data Bank, the central clearinghouse created by Congress in 1986 to confidentially share information of alleged physician misconduct.
The data bank is a repository for various reports, including malpractice payments, discipline by state medical boards and loss of hospital privileges. States are able to use the database to track physicians, but use of it varies widely.
Series exposed problems
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.
In March, a separate Journal Sentinel/MedPage Today story highlighted the case of a California physician who had not been disciplined despite being the subject of FDA warning letters dating back several years.
In June, the California medical board began proceedings against Michael Arata, MD, a physician who had been performing risky and unproven vein-opening procedures on multiple sclerosis patients.
Arata had been the subject of three FDA letters dating back to 2012. On June 28, the California board filed a 14-page action that could lead to the revocation or suspension of his license.
In August, the Journal Sentinel/MedPage Today highlighted several physicians who had received warning letters but had not been disciplined by their state medical boards.
Another case involved Thomas Gionis, MD, a physician with a criminal record with stem cell clinics in California, Florida, and New York. The FDA sent him a warning letter citing potential contamination of the products, not having a license to use them in people, and numerous manufacturing process failures.
This story was reported as a joint project of the Milwaukee Journal Sentinel and MedPage Today.