MASSDEVICE ON CALL — $1 billion: The price for settling federal beef over J&J’s drug marketing. Federal prosecutors are seeking about $1 billion from Johnson & Johnson (NYSE:JNJ) to settle a criminal investigation into the company’s marketing of an antipsychotic drug, according to The Wall Street Journal.
The publication, which cited "people familiar with the matter," reported yesterday that prosecutors are pushing the New Brunswick, N.J.-based company to reach a settlement soon.
The federal government has been conducting a probe into whether J&J‘s Janssen Pharmaceutica unit promoted the drug Risperdal for off-label, or unapproved, uses.
In a May 10 filing with the Securities & Exchange Commission, J&J said it set aside an unspecified amount of money for a potential settlement over the allegations.
The company said in the filing that criminal and civil litigation was likely if a negotiated resolution cannot be reached with the government over the alleged off-label promotion of the drug.
The WSJ reported the J&J officials were surpised at the size of the amount of the proposed settlement. Prosecutors have been using a $1.4 billion settlement that Eli Lilly & Co. (NYSE:LLY) reached in 2009 as a yardstick for the sum. Eli Lilly was settling an investigation into improper marketing activities of its antipsychotic drug Zyprexa, but the duration of company’s malfeasance was longer, according to the WSJ‘s report.
J&J said in its SEC filing that a resolution over the Risperdal allegations could have a material impact on the company’s quarterly financial results.
If Medicare was private, would it be cheaper? Princeton economist Uwe Reinhardt tries to answer that question in The New York Times‘ Economix blog. "[I]t is not a stretch," he writes, "to argue that the Milliman Medical Index [by Milliman Inc., the Seattle-based employee-benefit consulting and actuarial company,] bears directly on the hypothesis that private health insurers are able to control the growth in per-capita health spending better than Medicare can."
Fight infections with sugar, scientists say. A discovery by researchers at the Boston University College of Engineering could help create a new weapon in the daunting battle against recurring, potentially lethal bacterial infections such as staphylococcus and streptococcus. And the weapon is a modified form of sugar. James Collins, a William Fairfield Warren Distinguished Professor, an BU professor of biomedical engineering, coauthored a study on the sweet science that appears in the May 12 issue of Nature, reports BU Today.
FDA releases PMA data. As a pilot program under the CDRH Transparency Initiative, the FDA released some summary review memos for 180-day PMA supplements relating to design changes in the pre-market approval process. The release includes summary review memos from the application process for certain devices.
FDA "struggles" to find experts without conflicts of interest. At a meeting held by the FDA to discuss the reauthorization of the Medical Device User Fee and Modernization Act, the agency suffered harsh criticism from company officials disapointed with its performance.
From the FDA’s minutes of the event:
Stakeholders questioned how FDA determines which panel member a homework assignment is sent to. FDA looks at the backgrounds and expertise of an entire panel roster to pick the most appropriate individuals and to screen for conflict of interest. FDA often struggles to find appropriate experts that do not have real or perceived conflicts of interest. Stakeholders asked if FDA tracks problems with conflicts of interest and if data are available. FDA does keep data relating to conflicts of interest and committee membership; although conflict of interest is assessed for homework assignments, FDA does not keep specific data on this.
Following FDA’s comments regarding a high attrition rate at CDRH, stakeholders asked where people are going when they leave CDRH. FDA indicated that staff seem to move to a variety of places, including reassignments within the Agency, consulting, and industry. FDA believes people often leave due to the high workload volume.
In reference to FDA’s proposal for increased training capacity, stakeholders asked FDA to outline their priorities for who will receive what types of training. FDA indicated that their first priority is to train new reviewers (which currently comprise roughly half of the review staff). The second priority would be to offer training in specific areas of expertise to keep more experienced reviewers ahead of the latest developments in their fields, help improve performance, and prepare for the review of new technologies. Stakeholders indicated support for such training.