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  • Regulatory NewsRegulatory News

    FDA Warns Japanese Company for Impeding Inspection

    The US Food and Drug Administration (FDA) has warned Japanese active pharmaceutical ingredient (API) maker Nippon Fine Chemical Co., Ltd for impeding an FDA investigator from conducting an inspection of the company's facility in Takasago City, Japan, last December. According to FDA, Nippon Fine Chemical employees physically blocked an FDA investigator from conducting portions of the inspection, refused to hand over records and prevented FDA from taking photographs of eq...
  • J&J to Pay $2.2 Billion for Off-Label Marketing of Risperdal in Third-Largest Settlement Ever

    The US Department of Justice (DOJ) has announced that Johnson & Johnson will pay at least $2.2 billion to resolve claims that it improperly marketed three drugs for indications not approved by the US Food and Drug Administration (FDA). The amount, which includes fines, forfeitures and settlement fees, amounts to one of the largest healthcare-related civil settlements in US history. Background The settlement between J&J and DOJ has long been in the works. In Jun...
  • Ranbaxy Pleads Guilty to Felony Charges in Largest False Claims Case Ever

    The US Department of Justice (DOJ) has announced that Indian generic pharmaceutical manufacturer Ranbaxy has pleaded guilty to three felony charges, including lying to the US Food and Drug Administration (FDA), that will result in the company paying US authorities $500 million in penalties. Background The announcement , made 13 May 2013, comes as the result of a long-running investigation into the practices of Ranbaxy, which markets several pharmaceutical products in t...
  • Trade Group Calls for Mutual Inspection Regime to Safeguard API Supply Chain

    • 13 November 2012
    The European Fine Chemical Group (EFCG) , an industry association of chemical manufacturers-including more than 150 devoted to pharmaceutical manufacturing-is calling for mandatory inspections of all global active pharmaceutical ingredient (API) manufacturing sites through the use of mutual recognition agreements. In a 12 November statement, EFCG said it was, "Proposing a global harmonization of the rules and regulations governing the manufacture of APIs to level the wo...
  • Abbott Hit with $1.5 Billion Fine for Off-Label Marketing

    Life sciences manufacturer Abbott has pleaded guilty to charges of unlawfully promoting its anti-seizure drug Depakote (divalproex sodium) and will pay a total of $1.5 billion in fines and be subject to a five-year probationary period, the Department of Justice (DOJ) announced on 2 October. Under the settlement, Abbott will pay a $500 million criminal fine, forfeit $198.5 million in earnings and pay $800 million to state and federal government. The fines and penalties...
  • Proposed Bill Exempts Minor First-Time Regulatory Violations from Civil Fines

    • 02 August 2012
    A new bill proposed in the US House of Representatives would provide relief to small companies and other entities found to be violating paperwork-based regulations for the first time. The bill, the Providing Assistance with the Paperwork from Excessive Regulations Act of 2012 , was introduced 26 July 2012 by Rep. Austin Scott (R-GA) . Under the act, first-time offenders would not be assessed a civil fine if they commit a "paperwork violation." Though the legislat...
  • GSK Settles Charges, Agrees to Record-Setting Fine

    British pharmaceutical manufacturing giant GlaxoSmithKline has agreed to pay a record-setting $3 billion fine to settle criminal and civil liabilities related to marketing and general practices used to promote three of its best-selling drugs. In a statement released 2 July , US Department of Justice (DOJ) officials said GSK plead guilty to three counts of criminal conduct, including respective counts of misbranding antidepressants Paxil (paroxetine) and Wellbutrin (bupr...
  • House Passes Bill Enhancing Penalties for Counterfeiters

    • 19 June 2012
    The US House of Representatives passed a bill on Monday, 18 June that would update the US' criminal code to establish harsher penalties for those found guilty of counterfeiting pharmaceutical products. The legislation, the Counterfeit Drug Penalty Enhancement Act of 2011 , is sponsored by Rep. Patrick Meehan (R-PA) and was introduced in the House in December 2011. An identically-titled companion bill first sponsored by Sen. Patrick Leahy (I-VT) is still before the S...
  • Reports: Johnson & Johnson to Pay $2.2 Billion to Settle Risperdal Marketing Probe

    Life science manufacturing giant Johnson & Johnson (J&J) is in the final stages of agreeing with federal prosecutors to pay an estimated $2.2 billion to settle charges of improperly marketing its blockbuster antipsychotic drug Risperdal, reports Bloomberg . The $2.2 billion sum would, in addition to settling Risperdal claims, also settle litigation regarding the marketing of J&J's schizophrenia drug Invega and congestive heart failure drug Natrecor, report...
  • Abbott Slammed with $1.5 Billion Fine for Off-label Depakote Marketing

    Pharmaceutical manufacturer Abbott Laboratories has agreed to pay a near-record $1.5 billion in fines for the off-label promotion of its anti-seizure drug Depakote, with the total to be split between the federal government, states and consumers. In a lengthy statement released by the Department of Justice (DOJ), Deputy Attorney General James M. Cole called the settlement a "strong message to other companies" not to engage in fraud. DOJ explained in its statement that ...
  • J&J Earnings Drag as Regulatory Problems Accumulate

    Life sciences giant Johnson & Johnson (J&J) managed to increase first quarter profits by 12.5% despite a decrease in revenue of 0.2%, the company said in a statement. But the company's profits were sorely depressed by a series of regulatory issues, including recalls, shortages and legal battles, reports The Associated Press. Among J&J's many issues during Q1: The US Department of Justice rejected a settlement between the company and the US government ove...
  • Arkansas Slams J&J With $1.2 Billion Fine for Risperdal Marketing Tactics

    • 12 April 2012
    An Arkansas judge slammed Johnson & Johnson (J&J), the parent company of subsidiary Janssen Pharmaceuticals, with a $1.2 billion dollar fine after Janssen was found to have engaged in deceptive marketing practices for its drug Risperdal, reports The New York Times . Not only is the fine one of the largest monetary penalties ever levied upon a drug company, reports The Times , but it also opens the door for many subsequent lawsuits. "Most attorneys general can ...