Healthy Skepticism Library item: 17729

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Silverman E
J&J Pays $81M Over Off Label Marketing Charges
Pharmalot 2010 Apr 29
http://www.pharmalot.com/2010/04/jj-pays-81m-over-off-label-marketing-charges/

Full text:

The health care giant’s Ortho-McNeil Pharmaceutical and Ortho-McNeil-Janssen Pharmaceuticals subsidiaries are ponying up $81 million in order to resolve criminal and civil lawsuits charging the units with illegally promoting the Topamax epilepsy drug.
This is one of three such agreements the Justice Department announced this week. Also today, Schwarz Pharma will pay $22 million for failing to tell the Centers for Medicare and Medicaid Services that two unapproved drugs didn’t qualify for coverage under federal health care programs. And earlier this week, AstraZeneca agreed to pay $520 million for off-label promotion of the Seroquel antipsychotic (see here).
Unlike the J&J charges, these two oher cases didn’t involve criminal charges. One thing all three settlements have in common, however, is that no individual executives were named. This has become an issue. Earlier this month, Lewis Morris, the Health and Human Services Inspector General, said that drugmakers that repeatedly defraud the government may be forced to sell meds, relinquish product exclusivity, or fire execs and have them banned from working at other companies that do business with the government (see here).
Ortho-McNeil agreed to plead guilty to a misdemeanor and pay a $6.14 million criminal fine, and Prtho-McNeil-Janssen Pharmaceuticals will pay $75.37 million to resolve civil allegations under the False Claims Act. The federal share of the civil settlement is $50.6 million and the state Medicaid share of the civil settlement is $24.7 million. Two whistleblowers will receive payments totaling more than $9 million from the federal share of the civil recovery (see Justice Department statement and the settlement).
The government alleged Ortho-McNeil promoted Topamax for off-label psychiatric uses through a program called “Doctor-for-a-Day, in which the J&J unit hired outside physicians to join sales reps in visiting other docs and to speak at meetings and dinners about prescribing Topamax for unapproved uses and doses.
One whistleblower, Gary Spivack, says he learned of this when he attended a “Psychiatry Consultants’ Conference” sponsored by the J&J unit. The attendees were paid $500 each or more as “consultants” simply to show up and listen to company presentations. The vast majority concerned off-label uses of Topamax and effectiveness claims for unapproved uses, according to a statement from Spivack (here is his lawsuit).