Zane Memeger, the U.S. Attorney for the Eastern District of Pennsylvania, said recent appeals court decision overturning the conviction of a pharmaceutical sales representative will not, at least for now, have a material effect on prosecutions of drug and health-care cases in this region.
Last year, the Court of Appeals for the Second Circuit overturned the conviction of Alfred Caronia, who allegedly violated FDA rules by promoting drugs off-label, meaning for uses not approved by the agency. The appeals panel vote was 2-1 and the majority wrote in a carefully worded opinion that the trial jury convicted Caronia of exercising his Constitutionally-protected right to free speech. The dissenting judge on the appeals panel was not happy because it could turnover consumer protections against medicine being sold for any use.
Links to earlier Inquirer and PhillyPharma stories on this are here and here.
Business groups, including the Pharmaceutical Research and Manufacturers of America, celebrated the decision, hoping it would give drugmakers greater freedom to promote their medicine.
Regulators, consumer groups and plaintiffs' lawyers were appalled at the idea that the Supreme Court might eventually agree.
The Justice Department and Department of Health and Human Services, which oversees FDA, decided not to challenge the Second Circuit decision, which probably should be viewed more as a tactic than a surrender. With no challenge, it won't immediately go to the Supreme Court and is limited to New York, Connecticut and Vermont, the area covered by the Second Circuit.
"The Second Circuit decision is not binding on other areas, but it can be relied upon for guidance," Memeger said. "The issue was prosecution of free speech, per se."
Memeger said his prosecutors will continue to focus on finding evidence misbranding, which remains illegal, and the more commonly understood term - lying.
"There is no right of a company or an individual to make false and misleading statements about the use of a drug," Memeger said. "I don't see a difference in prosecuting our cases as vigorously as we have. You want to make sure you have proof and not just a simple statement."
Memeger answered Inquirer questions after Justice-HHS released its annual report on the results of the Health Care Fraud and Abuse Control Program, which returned $4.2 billion to the federal government.
A link to Tuesday's Inquirer story is here.
Links to the joint statement by the government is here and a full report is here.
"This is a major priority of the department, [Justice Department Secretary] Eric Holder and the Obama Administration," Memeger said. "We're responsible for protecting the taxpayer dollars and to the extent we can weed out waste, fraud and abuse we'll do that."
Memeger said that most people and companies try to abide by the law, and to help that, prosecutors and regulators have tried to discuss regulations with companies. Beyond logic, it's also stipulated in the law increasing the funding to fight health-care fraud.
"Over time, entities have come to learn the expectations," Memeger said.
Checking on drug companies is only one phase of the fraud-fighting efforts. Prosecutors have also focused on fraudulent billing by ambulance companies, home health-care operators, hospitals, and doctors.
"Most companies try to do the right thing, but there is a subset that disrespects the law, and that's what we go after," Memeger said. "There is a large sum of money going to provide services in health care and there are going to be people who could care less about the law."