Doctors aren't getting the skinny on drug side effects from pharma reps, a new study finds. Even the most serious risks are often overlooked, the survey found. And while probes of off-label marketing abound, enforcement of risk disclosures during sales visits is mostly absent.
The allegations in a recently released lawsuit against Cephalon suggest that company was particularly obscene about pushing off-label uses, because at the time it was operating under a Corporate Integrity Agreement forged after getting caught for similar problems a few years earlier.
Two former Warner Chilcott reps have blown the whistle. In a False Claims Act lawsuit unsealed last week, the ex-salespeople detail a long series of allegations, including kickbacks, privacy violations and off-label shenanigans.
Par Pharmaceutical has joined the off-label rogue's gallery. The drugmaker agreed to pay $45 million to wrap up charges that it promoted Megace ES, a treatment for appetite loss in AIDS patients, for a variety of unapproved uses.
FDA expected it, and now it's official: The Justice Department won't be backing away from off-label marketing. That's in spite of the instantly notorious appeals court decision in Caronia v. U.S.
One Amgen whistleblower is balking at the government's off-label marketing settlement--but the federal court is having none of it. Dr. Joseph Piacentile, who worked undercover to gather evidence for the prosecutors' case, claims he and other whistleblowers have had no say-so in the settlement, Bloomberg reports. And he wants his day in court.
In Hollywood, when undercover agents are planning to secretly record a meeting, there's often a scene meant to engage the audience's fear and sympathy: "Are you wearing a wire?" someone accuses, usually someone armed with a gun or enormous fists.
While we're still digesting the news that one U.S. appeals court figures off-label discussions are protected by the First Amendment, another panel is considering a similar argument. The Ninth Circuit U.S. Court of Appeals will hear an appeal from former InterMune CEO Scott Harkonen, convicted on wire fraud for a news release that touted the lung drug Actimmune.
In the first half of 2012 alone, a record year for both federal and state financial recoveries, there were $5 billion and $1.6 billion in settlements, respectively. Three of the 10 largest settlements and judgments in the 20-month period were single-state settlements. The report's researchers were unable to determine what prompted some states to take actions individually, and while federal penalties still make up the bulk of the cost to pharma, aggressive states have clearly added to the litigation risk for drugmakers. Click here to check out the full report >>
Lawyers are pulling no punches in that Risperdal litigation playing out in Philadelphia court. After trying to force Johnson & Johnson CEO Alex Gorsky onto the stand to talk about the company's Risperdal marketing practices, plaintiff's attorneys want ex-FDA chief David Kessler to testify--and Kessler is on record saying that J&J's Janssen unit broke the law by marketing Risperdal off-label.