FDA: Janssen Pharma - Pleads Guilty - To Pay Over $1.6 billion - re: Risperdal

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Updated August 29, 2020

The link in the original post broke.

You might also be interested in the DOJ's statement about the issue:

Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations
Allegations Include Off-label Marketing and Kickbacks to Doctors and Pharmacists - Justice.gov

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Press Announcements > FDA: Janssen Pharmaceuticals, Inc. to plead guilty and pay over $1.6 billion to resolve allegations of misbranding and filing false claims for its schizophrenia drug Risperdal:

"U.S. Department of Justice today announced a guilty plea agreement with Janssen Pharmaceuticals, Inc., (JPI) of Titusville, N.J., and a $400 million criminal fine for introducing a misbranded drug, Risperdal (risperidone), into interstate commerce. A Johnson & Johnson Company, JPI must also pay $1.25 billion under a separate civil settlement concerning the same drug. The combined criminal plea and civil settlement agreement related to Risperdal totals more than $1.67 billion."

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Serious Gaps in US Drug Safety

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Updated February 2, 2021:

Links in the original post broke.

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This caught my eye in the National Journal, Pew Study Finds Gaps in FDA Oversight of Imported Drugs.

In a nutshell, Pew Finds Serious Gaps in Oversight of U.S. Drug Safety points to the Pew white paper that finds that increased outsourcing of manufacturing, a complex and globalized supply chain and criminal actors create the potential for counterfeit or substandard medicines to enter the supply chain and reach patients.

FDA Says Watch Out For Fake Alli Capsules

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The U.S. Food and Drug Administration (FDA) is warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit).  The counterfeit Alli product looks similar to the authentic product, with a few notable differences. The counterfeit Alli has:

• Outer cardboard packaging missing a “Lot” code;
• Expiration date that includes the month, day, and year (e.g., 06162010); authentic Alli expiration date includes only the month and year (e.g.,: 05/12);
• Packaging in a plastic bottle that has a slightly taller and wider cap with coarser ribbing than the genuine product;
• Plain foil inner safety seal under the plastic cap without any printed words; the authentic product seal is printed with “SEALED for YOUR PROTECTION”;
• Contains larger capsules with a white powder, instead of small white pellets.

Consumers who believe they have received counterfeit Alli are asked to contact the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).

Related Posts:
Counterfeits In The Global Drug Supply

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FDA Reports Another Extortion Scam by FDA Impersonators

The FDA is warning the public about criminals posing as FDA special agents and other law enforcement personnel as part of an international extortion scam.

It goes something like this. The criminals call the victims (who in most cases previously purchased drugs over the Internet or via "telepharmacies") and identify themselves as FDA special agents or other law enforcement officials. The criminals inform the victims that purchasing drugs over the Internet or the telephone is illegal, and that law enforcement action will be pursued unless a fine or fee ranging from $100 to $250,000 is paid. Victims often also have fraudulent transactions placed against their credit cards.  The criminals always request the money be sent by wire transfer to a designated location, usually a foreign county. If victims refuse to send money, they are often threatened with a search of their property, arrest, deportation, physical harm, and or incarceration.

Anyone receiving a telephone call from a person purporting to be an FDA or other law enforcement official who is seeking money to settle a law enforcement action for the illegal purchase of drugs over the Internet should refuse the demand and call the FDA’s Office of Criminal Investigations Metro Washington Field Office at (800) 521-5783 to report the crime.

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FDA - Global Drug Supply Chain Needs Better Oversight

Updated August 3, 2024

The original link broke.

You might also like:

Office of Global Policy and Strategy - FDA.gov

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We're still reeling from the tainted heparin situation, and I suspect that it's only the tip of the iceberg. A rising percentage of drugs are coming from China and India, reports this ASHP News article, "World's Drug Supply Chain Needs Better Oversight, FDA Says." The associate commissioner for policy and planning at FDA is quoted, and here's a small sample of highlights . . .

• "where there are economic incentives and/or there is lax regulatory oversight, there is going to be greater opportunity for risky or criminal behavior"
• "If we have good behavior, we want to facilitate compliance. If we have risky behavior, we want to provide deterrence. And with criminal behavior, we need rapid detection and aggressive enforcement. And electronic track and trace can play an important role in it."

Previous Posts:
Gambling With Life - Counterfeit Drugs - Like ED Drugs (Viagra)
Counterfeiters Can Get Life In Jail

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