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Showing posts with label Office of Criminal Investigations. Show all posts
Showing posts with label Office of Criminal Investigations. Show all posts

Wednesday, July 23, 2014

FDA warns of compounded drug recall by Texas firm

WASHINGTON — The Food and Drug Administration warned doctors Wednesday not to use compounded drugs from a Texas specialty pharmacy due to potential risks of contamination.
The agency says FDA inspectors recently uncovered unsanitary conditions at Unique Pharmaceuticals’ plant in Temple, Texas. The inspections revealed production problems in several drug lots that were supposed to be sterile.
“Using these products puts patients at an unacceptable risk for serious infection,” said Carol Bennett, an official in the FDA’s drug center.
At the behest of regulators, Unique Pharmaceuticals has recalled all non-expired, sterile products distributed across the U.S., including a fluid used to clear mucus in patients with respiratory conditions. The company has also halted production of all other sterile drugs, which are generally solutions administered via injection or intravenous infusion. A spokesman for the company said it continues to produce other forms of drugs that do not require sterile conditions.
“We are diligently working to address FDA’s concerns noted before the recall,” said David Shank, in a statement. “We have commissioned third-party independent experts to address those concerns and ensure the safety of our compounded preparations for our customers.” Shank added that the recall could contribute to shortages of medicines already in short supply.
The FDA said in a statement it is not aware of any illnesses linked...
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Tuesday, November 5, 2013

Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigatio

Today's post is shared from justice.gov

Allegations Include Off-label Marketing and Kickbacks to Doctors and Pharmacists\Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider. The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.

“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” said Attorney General Eric Holder. “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud. And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people.”

The resolution includes criminal fines and forfeiture for violations of the law and civil settlements based on the False Claims Act arising out of multiple investigations of the company and its subsidiaries.