SHOTLIST:

POOL - AP CLIENTS ONLY

Washington - 4 November 2013

1. SOUNDBITE (English) Eric Holder, Attorney General: "Johnson & Johnson and three of its subsidiaries have agreed to pay more than $2.2 billion to resolve criminal as well as civil claims that they marketed prescription drugs that were never approved as safe and effective and that they paid kickbacks to both physicians and pharmacies for both prescribing and promoting these drugs."

2. Mid of people on stage with Holder

3. SOUNDBITE (English) Eric Holder, Attorney General: "These are not victimless crimes. Americans trust that the medications prescribed for their parents, and for their grandparents, for their children, and for themselves are selected because they are in the patient's best interest. Laws enacted by Congress and the enforcement efforts by the Food and Drug Administration provide certain safeguards to ensure the drugs are approved for uses that have been demonstrated as safe as well as effective. Efforts by drug companies to introduce their drugs into interstate commerce for unapproved uses subvert those laws. Likewise, the payments of kickbacks undermines the independent medical judgement of health care providers, it creates financial incentives to create the use of certain drugs potentially putting the health of some patients at risk. Every time pharmaceutical companies engage in this type of conduct, they corrupt medical decisions by health care providers, jeopardize the public health, and take money out of taxpayers' pockets."

STORYLINE:

Johnson & Johnson and its subsidiaries have agreed to pay over $2.2 billion to resolve criminal and civil allegations that the company promoted powerful psychiatric drugs for unapproved uses in children, seniors and disabled patients, the Department of Justice announced on Monday.

The allegations include paying kickbacks to physicians and pharmacies to recommend and prescribe Risperdal and Invega, both antipsychotic drugs, and Natrecor, which is used to treat heart failure.

The figure includes $1.72 billion in civil settlements with federal and state governments as well as $485 million in criminal fines and forfeited profits.

The agreement is the third-largest U.S. settlement involving a drugmaker, and the latest in a string of legal actions against drug companies allegedly putting profits ahead of patients. In recent years, the government has cracked down on the pharmaceutical industry's aggressive marketing tactics, which include pushing medicines for unapproved, or off-label, uses. While doctors are allowed to prescribe medicines for any use, drugmakers cannot promote them in any way that is not approved by FDA.

"Every time pharmaceutical companies engage in this type of conduct, they corrupt medical decisions by health care providers, jeopardize the public health, and take money out of taxpayers' pockets," said Attorney General Eric Holder, in prepared remarks to reporters.

In its plea agreement, J&J subsidiary Janssen admitted that it promoted Risperdal to nursing home practitioners to control erratic behavior in seniors with dementia _ a use that is explicitly barred in the drug's label because the drug can increase the risk of stroke and death in elderly patients. Antipsychotic drugs are known for their sedative effects and are occasionally used to treat post-traumatic stress disorder, though that use is not approved by the FDA.

In a separate civil complaint, the government alleges J&J and Janssen also promoted the drug as a way to control behavioral problems in children and mentally disabled. The drugmaker allegedly downplayed Risperdal's side effects while also paying kickbacks to the nation's largest long-term care pharmacy to recommend the drug to prescribers. The off-label prescribing contributed to millions of dollars in spending federal and state health programs like Medicare, Medicaid and the Department of Veterans' Affairs.

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