Most high-profile legal cases involving pharmaceutical companies in recent years have targeted off-label marketing and related
pricing and promotional activities. Now federal law enforcement officials and food and drug lawyers anticipate a rise in legal
actions involving lax adherence to cGMPs that result in adulterated products. With manufacturing problems recently linked
to disruptive drug shortages and deaths associated with contaminated compounded injectables, drug quality issues have moved
on to the legal and enforcement radar screen.
Biopharmaceutical companies will continue to face violative marketing cases and multimillion-dollar fines brought by whistleblowers
and raised by FDA enforcers. In an end-of-the-year flurry of settlements in December 2012, Pfizer agreed to pay nearly $100
million to resolve federal and state charges for illegal off-label marketing. Amgen paid $762 million to settle criminal and
civil charges related to violative marketing of several leading therapies, and Sanofi agreed to pay $109 million to resolve
kickback charges related to an injectable treatment. These payments, however, are paltry compared to earlier billion-dollar
settlements by several prominent pharmaceutical manufacturers, with GlaxoSmithKline's $3 billion fine in July 2012 topping
the list. Federal and state prosecutors and attorneys expect violative marketing cases to continue, but there may be a slow-down
as lawyers and litigators digest the impact of the US vs. Caronia ruling on Dec. 2, 2012. That case has raised questions about FDA's authority to limit a marketer's ability to discuss off-label
claims that are not false or misleading.
For all these reasons, enforcement officials are looking to bring more cases against manufacturers for failing to comply with
GMPs and quality standards. There are more whistleblowers going to qui tam lawyers with evidence of violations related to GMPs for drugs and biologics, observed former Department of Justice (DOJ)
official Eugene Thirolf at the December 2012 enforcement conference sponsored by the Food and Drug Law Institute (FDLI). Michael
Blume, director of DOJ's consumer protection branch, reported that he and others are looking to assess the impact of GMP issues
on consumers, while weighing the effect of litigating manufacturing compliance issues on drug production. His colleague, Jill
Furman, explained that in selecting cases, DOJ asks how bad was the misconduct, if management condoned the misconduct, and
if the alleged activity affects the integrity of the drug regulatory process.
Resources to carry out a case are an important consideration, Furman observed, but "resources are never the issue in taking
on a drug company." Blume said he doesn't expect settlement payments in GMP cases to be as large as those from off-label marketing
suits, yet manufacturing issues raise the possibility of charges against individual corporate executives, including penalties
that exclude an individual from doing business with the government.