The FDA has traced 56 more doctors and medical practices that may have bought phony versions of Avastin. As The Wall Street Journal reports, the agency notified the physicians and clinics in 13 states about the counterfeits and warned them not to use the products.
The latest batch of letters follows previous dispatches to 20 doctors and clinics about fake Avastin. After the first round, FDA publicly warned that a batch of counterfeits had emerged in the U.S. Then, earlier this month, FDA said it tracked another batch, sold under Avastin's Turkish brand name, Altuzan.
In both of the previous cases, the counterfeits were found to be devoid of the Roche ($RHHBY) drug's active ingredient. No patients reported adverse effects from the phony versions, but they obviously didn't benefit from the treatment, either.
The fakes have been tracked to the Middle East and beyond, traveling through U.S. and Europe along the way. The latest letters pointed to Richards Pharma, which operates under several other names; that company was also implicated in previous warnings.
As investigators told The Wall Street Journal, the cancer-drug reimbursement system offers an incentive to doctors to save money on drug purchases. By buying drugs from other countries that put tight controls on prices--unlike the U.S.--doctors can then bill insurers and Medicare for the full U.S. price, pocketing the difference, the investigators told the WSJ. Some doctors named in the letters have said they didn't know they were buying foreign drugs, while others have denied doing businesses with the fake drugs' distributors.
Roche's U.S. unit Genentech has said genuine Avastin is available to physicians through four authorized distributors, while another four sell to hospitals. "It's deeply concerning that doctors are buying drugs of uncertain provenance," Pew Health Group's Allan Coukell told the Journal. "What we're seeing may be the tip of the iceberg."
(Image courtesy of the FDA)
- read the WSJ story