A member of the defense team in the recent failed prosecution of GlaxoSmithKline general counsel Lauren Stevens cited several lessons learned on Thursday.
“Have outside counsel sign your letters” when communicating with the U.S. government, Colleen Conry, co-leader of Ropes & Gray LLP’s government enforcement group, advised compliance officers at a conference in Washington, D.C. The government expects outside counsel to be “a little more aggressive” in replying to inquiries, which can possibly prevent misunderstandings down the line, she said.
In May U.S. District Judge Roger Titus in Maryland threw out the case against Stevens, saying it would be a “miscarriage of justice” to let it proceed to a jury. Stevens had been criminally charged with obstructing justice and lying to the government in an investigation of GSK’s marketing of the depression drug Wellbutrin.
The other lessons: “Don’t assume that the matter is closed” if the government stops responding to a company’s communications, and be transparent, Conry said.
Stevens, a former police officer in her 60s, responded on GSK’s behalf to the Food and Drug Administration when it made a request in October 2002 for voluntary disclosure of information about the marketing of Wellbutrin. The government suspected the drug company was promoting the drug for weight loss, which would have been illegal because the FDA had not approved the depression drug for weight loss, known as an “off-label” use.
The company chose Stevens for the job because she had a reputation for scrupulousness, Conry said. ”She was in every way the answer, not the problem” in compliance, Conry said. Stevens worked with outside counsel at King & Spalding LLP, a top-tier health-care industry law firm.
Stevens and King & Spalding conducted an internal investigation, interviewing some 20 witnesses. A focus was a promotional program of the kind that drug companies today have dramatically scaled back, in which GSK enlisted physicians to give talks about Wellbutrin.
The internal probe found that some doctors had created slide decks with potentially legally problematic language, Conry said. The team of lawyers decided not to turn over the slide decks without meeting with the FDA. “Remember, this was a voluntary request” from the government for information, she said.
But the FDA never responded to the meeting requests. What the GSK team didn’t know was that by the spring of 2003, a whistleblower had come forward in the matter. The FDA lawyers “go slient, and the team thinks they have lost interest,” Conry said. By late 2003, GSK had received a subpeona compelling the information, which was an indication that a more serious government investigation had begun.
Stevens was indicted twice and charged with one count of obstructing an official proceeding, one count of concealing and falsifying documents to influence a federal agency and four counts of making false statements to the Food and Drug Administration. In her defense, Stevens argued she had relied on the advice of nationally recognized outside counsel.
The defense filed a Rule 29 motion moving to dismiss the case on the basis of lack of evidence. Titus, after saying in court that he had never granted such a motion, ruled in May that he would do so then. “[O]nly with a jaundiced eye and an inference of guilt that’s inconsistent with the presumption of innocence could a reasonable jury ever convict this defendant,” Titus said from the bench.
Regarding transparency, Conry said that if the GSK legal team had been “explicit with the FDA that in this voluntary request [they] would not hand over the [slide] decks without a meeting,” it would might have helped clarify the matter.
Conry is a former senior litigation counsel in the Criminal Fraud Section of the Department of Justice. She gave her remarks at the Pharmaceutical and Regulatory Compliance Congress, an annual event organized by the Pharmaceutical Compliance Forum, a group of senior compliance officers of some 50 pharmaceutical companies.
U.K.-based drug maker AstraZeneca PLC will pay about $520 million to resolve allegations the company promoted off-label uses for the antipsychotic Seroquel, the Justice Department said.
The drug maker disclosed in October that it had set aside $520 million for the resolution, which includes a civil settlement and corporate integrity agreement.
Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius announced the settlement Tuesday, along with Tony West, Assistant Attorney General of the Civil Division, and acting U.S. Attorney Michael Levy of Pennsylvania’s Eastern District.
Drug makers are barred from marketing off-label, or for uses not approved by the U.S. Food and Drug Administration. Seroquel, whose sales reached $4.9 billion in 2009, is approved to treat schizophrenia, bipolar disorder and depression.
According to the department, AstraZeneca promoted Seroquel to psychiatrists and other physicians for unapproved uses, including aggression, Alzheimer’s disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder and sleeplessness.
The company targeted doctors who did not typically treat patients for its approved uses, such as primary care physicians, and pediatric and adolescent physicians, according to the department.
The drug maker was also accused of enlisting doctors to give speeches promoting off-label uses of the drug, and recruiting them as authors of ghostwritten articles on studies the doctors did not conduct. AstraZeneca then brandished the articles in promotional messages about unapproved uses of Seroquel, the department alleged.
The drug maker allegedly submitted false claims for payment to a variety of federal insurance programs, including Medicaid, Medicare and TRICARE programs, and to the Department of Veterans Affairs, the Federal Employee Health Benefits Program and the Bureau of Prisons.
“Illegal acts by pharmaceutical companies and false claims against Medicare and Medicaid can put the public health at risk, corrupt medical decisions by health care providers, and take billions of dollars directly out of taxpayers’ pockets,” Holder said. ”We will not let such actions stand.”
Under the terms of the agreement, AstraZeneca made no admission of wrongdoing.
The federal government will receive about $302 million and state Medicaid programs and the District of Columbia will share the remaining $218 million.
The investigation spawned from whistleblowers’ complaints filed in 2004 and 2006 in federal court in Philadelphia. One of the whistleblowers, James Wetta, was also a relator in the government’s investigation of Eli Lilly & Co. for off-label marketing of its antipsychotic Zyprexa. The drug maker agreed to pay $1.4 billion to resolve the allegations last year.
In a record-breaking settlment last year, Pfizer Inc. agreed to pay $2.3 billion to resolve allegations it improperly promoted pain reliever Bextra.
Allergan, Inc., which makes the wrinkle-remover Botox, filed a lawsuit against the FDA in October challenging the ban on off-label marketing on First Amendment grounds. The company claims the practice infringes commercial free speech and free speech in general.
The AstraZeneca settlement agreement is embedded below.