• Regulatory NewsRegulatory News

    Senator Seeks More From Mylan on Intent to Repress Teva’s EpiPen Generic

    Sen. Patty Murray (D-WA) on Tuesday sent a letter to Mylan CEO Heather Bresch seeking more details, including e-mail communications, on the ways that Mylan attempted to keep Teva’s generic EpiPen from coming to market. Background As part of an attempt to quell the furor over its more than 400% price increase for its life-saving EpiPen, Mylan announced in August that it would soon launch an authorized generic version of its autoinjector for half the price of the brand-n...
  • 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...
  • UK Man Sentenced to Prison after Falsifying Trials Data and Delaying Hundreds of Drugs

    UK regulators said Wednesday that they had, for the first time ever, gotten a man sentenced to prison for his role in falsifying pre-clinical data that was meant to support the regulatory approval of several drug products. The man, Steven Eaton, was sentenced on 17 April 2013 following an investigation by the Medicines and Healthcare Products Regulatory Agency (MHRA) into the practices of Eaton. The investigation was triggered after Aptuit, an international drug developm...
  • 'Record-Breaking Year' for Fraud Recovery Has Roots in Regulatory Missteps

    2012 was a record year for regulatory-related pain and government gain, claims a new report out from the US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG), the office responsible for overseeing fraud prevention and recovery efforts. The report , jointly authored by OIG and the US Department of Justice (DOJ), explained that 2012 saw the highest-ever amount of fines recovered from those who had defrauded or attempted to defraud the g...
  • Bill Seeks to End Pay-for-Delay Agreements

    A new piece of legislation introduced in the Senate would prohibit so-called "pay-for-delay" deals under the assumption that the deals delay the introduction of cheaper generic pharmaceutical medicines and are thus anti-competitive. Background The deals occur when a branded company and one or more generic companies settle patent litigation in such a way that the generic company agrees to delay introduction of its generic product for a period of time in return for a paym...
  • J&J Settles Court Cases In Advance of Testimony by Former FDA Commissioner

    • 05 October 2012
    Even after stepping down from his position as head of the US Food and Drug Administration (FDA), former Commissioner David Kessler seems to be having a strong impact on the fortunes of some pharmaceutical companies. Kessler had been called on to testify on behalf of litigants in a series of trials set to be heard in a Pennsylvania court room the week of 8 October regarding Johnson & Johnson's marketing of its antipsychotic drug Risperdal (risperidone). Litigants have...
  • J&J to Pay Millions in Marketing Lawsuit

    • 31 August 2012
    Johnson and Johnson will pay $181 million to settle a lawsuit about how it marketed an antipsychotic drug, but the company denies any wrongdoing, according to a PMLive report. The suit claims the drug, Risperdal, was promoted for uses not approved by the U.S. Food and Drug Administration and also made false claims about its effects. The payment will be distributed to 36 states and the District of Columbia, the report said. This is the latest round of problems J&J ha...
  • Pfizer Settles With SEC Over Charges it Bribed Foreign Regulatory Officials

    Pharmaceutical manufacturing giant Pfizer has settled corruption charges leveled against it by the Securities and Exchange Commission (SEC) and the Department of Justice (DOJ), both of which said the company had violated the Foreign Corrupt Practices Act (FCPA) by bribing foreign officials to win business and allow its products to access markets. SEC said in a statement the company and its agents had bribed officials in Bulgaria, China, Croatia, the Czech Republic, I...
  • Reports: J&J Reaches Agreement to Settle Lawsuit Over 'Tsunami of Regulatory' Problems

    • 13 July 2012
    Life science manufacturing giant Johnson & Johnson has reportedly reached a tentative settlement agreement with a group of shareholders who had sued the company over allegations of chronically mismanaging its operations, leading to large-scale manufacturing problems and regulatory difficulties. The Associated Press reports the agreement came after J&J agreed to "big changes, including a new committee of independent board members to get reports about legal and q...
  • 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...
  • Congress Advances Legislation Limiting Consent Decrees, Settlement Agreements

    • 26 June 2012
    A legislative proposal to limit the ease with which regulatory agencies are able to compel companies to enter into consent decrees is rapidly advancing in the House of Representatives. The Sunshine for Regulatory Decrees and Settlements Act ( SRDSA ) of 2012 (H.R. 3862) received approval from the Committee on the Judiciary on 27 March 2012 in a 20-10 vote. As Regulatory Focus reported in February, consent decrees are often used by the US Food and Drug Administratio...
  • 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...