WASHINGTON (AP) – Two subsidiaries of pharmaceutical giant Johnson & Johnson have agreed to pay more than $81 million stemming from allegedly illegal promotion of the epilepsy drug Topamax for psychiatric uses, the Justice Department announced.
Federal drug regulators approved Topamax as an anti-epileptic drug and for prevention of migraines.
The Justice Department case was the second settlement this week involving a pharmaceutical manufacturer’s alleged misconduct involving promotion of unapproved uses for a drug.
On Tuesday, Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius announced a $520 million settlement with AstraZeneca, resolving allegations of illegal marketing of the company’s antipsychotic drug Seroquel.
In the case involving Topamax, the government says Ortho-McNeil-Janssen Pharmaceuticals Inc. will pay over $75 million for alleged illegal promotion of the drug for a variety of psychiatric uses.
Ortho-McNeil Pharmaceutical LLC, a subsidiary of OMJPI, has agreed to plead guilty to a single misdemeanor violation of the Food, Drug and Cosmetic Act and to pay a $6.1 million criminal fine.
The government says that Ortho-McNeil Pharmaceutical promoted Topamax sales for unapproved psychiatric uses under a program called “Doctor-for-a-Day.” Under it, Ortho-McNeil hired outside physicians who joined sales representatives in visits to health care providers and to speak at meetings and dinners about prescribing Topamax for unapproved uses.
Topamax had been a blockbuster for Johnson & Johnson, helping to drive growth early in the decade, with sales topping $2 billion a year by 2006. The drug reached its peak sales of $2.7 billion in 2008, when it was the company’s second-best-selling drug.
That’s despite it only being approved initially for epilepsy – a seizure disorder for which there are more than a dozen competing treatments. About 3 million Americans have epilepsy.
Topamax was approved for a second use, preventing migraines, about five years ago. The drug got generic competition in March 2009, and sales plunged to just $148 million last year.
In a statement, Ortho-McNeil-Janssen Pharmaceuticals Inc. said it has been cooperating with the government since its investigation began in December 2003.
According to the statement, the guilty plea states Ortho-McNeil Pharmaceutical promoted the unapproved uses between 2001 and 2003.
OMJPI denies it engaged in any wrongful conduct, with the exception of acknowledging the admissions made by Ortho-McNeil Pharmaceutical LLC in connection with the misdemeanor plea, the company added.
The settlement resolves two lawsuits brought under the False Claims Act, in which whistleblowers can sue on behalf of the United States. More than $9 million of the settlement will go to the private citizens who brought the lawsuits.
Late in 2008, the FDA required Topamax and other anti-seizure drugs to carry warnings that they increase risk of suicidal thoughts and behavior.
Date: April 29, 2010
Source: Associated Press
Filed Under: Drug Discovery