A prominent La Jolla oncologist and his corporate medical practice admitted importing unapproved foreign cancer drugs at a deep discount, dispensing them to unwitting patients, billing Medicare as if the drugs were legitimate and pocketing the profits, federal officials announced Wednesday.
Dr. Joel I. Bernstein entered a guilty plea to a misdemeanor count of introducing an unapproved drug into interstate commerce, a cancer drug called “Mabthera”—intended for market in Turkey—and administering it to patients.
The approved U.S. drug with the same active ingredient is Rituxan, which is used to treat lymphomas and leukemias such as Non-Hodgkin lymphoma and chronic lymphocytic leukemia.
Bernstein, 59, entered his plea on Jan. 15 was released pending sentencing, scheduled for April 16.
On Wednesday, the doctor's medical practice, Dr. Joel Bernstein M.D. Inc., pleaded guilty to health care fraud.
According to the plea agreement with the corporation, Bernstein's employees purchased $3.4 million of foreign cancer drugs, knowing the U.S. Food and Drug Administration had not approved them for use in the United States.
From 2007 to 2011, Bernstein's office purchased the foreign drugs for significantly less than market value in the U.S. and then submitted claims to Medicare at the full reimbursement price, according to court papers.
The plea agreement for the corporation calls for $1.7 million in restitution to Medicare, plus forfeiture of $1.2 million in profits.
Authorities said the cases against Bernstein and his practice are the latest example of an alarming nationwide trend that potentially puts patients at risk by exposing them to foreign drugs—particularly injectable chemotherapy drugs—that are not vetted by the U.S. Food and Drug Administration.
—City News Service