FDA OCI Division Targeting Pharma Manufacturing Practices
March 11th, 2013 // 2:59 pm @ jmpickett
After the big meningitis outbreak that occurred last year at NECC, the criminal investigation unit of FDA, OCI, is going to be focusing more on the manufacturing practices of pharmaceutical companies.
Tomorrow – A Classic FDA Auditor Trick!
According to John Roth, the head of the Office of Criminal Investigations, FDA is working to make sure that companies are balancing their need for profit with the need to manufacture drugs in a responsible way.
The serious meningitis outbreak and some other recent GMP problem cases have caused FDA to take a closer look at this balance. Roth spoke to an American Bar Association conference in Las Vegas last week that was focused on white collar crime.
Roth stated in a panel discussion that FDA was considering whether the meningitis case revealed a systematic GMP problem in the industry that requires a broad response, or if it was more of an out liar.
The New England Compounding Center, based in Framingham, MA, filed for bankruptcy recently. More than 14,000 people were given vials of steroids that were tainted with fungus. The outbreak of meningitis has led to more than 30 deaths in the US, according to the CDC.
Compounding companies have in the past mostly been regulated by state agencies, not FDA. After the outbreak, FDA is trying to gain a bigger role in regulating compounding companies.
It is expected that FDA is going to take more aggressive actions in the future against bad manufacturing processes both at compounding companies and pharma companies.
FDA recently took over three J&J McNeil plants after there were numerous recalls there involving Tylenol and other common OTC drugs.
FDA in January got a consent decree against Ben Venue Labs, which is a branch of Boehringer Ingelheim. This consent decree restricted the firm from making drugs at its plant in Bedford OH until FDA determined it met GMP standards.
The agency’s move came after quality control problems at Ben Venue led to a shortage of the cancer drug Doxil, which Ben Venue produced for J&J as an outside contractor.
During his talk, Roth also cited a probe into a salmonella outbreak linked to peanut butter manufactured by Peanut Corporation of America.
The FDA had found PCA produced peanuts in unsanitary conditions and did not take adequate steps to prevent rodents and insects from getting into its plant in Blakely, Georgia.
In February, the Justice Department charged PCA’s former owner, Stewart Parnell, and several employees with fraud, conspiracy and obstruction of justice.
Parnell’s lawyers have said they were disappointed that the government had decided to pursue an indictment and were planning a “vigorous defense.”
Tomorrow – A Classic FDA Auditor Trick!
