• Court Orders FDA to Release Thousands of Documents on Surveillance Program

    The US Food and Drug Administration (FDA) has been ordered by a federal judge to release thousands of documents to an attorney representing former employees of the agency who now allege they were the subject of an illegal surveillance program. Judge James Boasberg of the District Court of DC sided with the National Whistleblowers Center (NWC) at the 23 July hearing, and has ordered the agency to turn over more than 4,000 pages of documents related to the case to NWC by...
  • Court: 'Pay-for-Delay' Practice Anticompetitive, Illegal

    In a potentially precedent-setting decision, a federal court has declared that payments made by companies to delay generic competition-also known as pay-for-delay settlements-are anti-competitive and illegal. The lawsuit, filed in the Third Circuit Court of Appeals in California, involved some of the pharmacy and pharmaceutical industry's largest companies, including CVS Pharmacy, Rite Aid, Walgreen, and Merck. The case was also supported by the Federal Trade Commissio...
  • Investigation into FDA Reveals 'Enemies List,' Extensive Monitoring Practices

    An investigation into the US Food and Drug Administration (FDA) by The New York Times has revealed the agency established an extensive monitoring program aimed at both restricting leaks of confidential information and establishing what The Times refers to as "an enemies list of sorts." The agency is currently under investigation--and is being sued by--various groups who allege the agency spied on its own employees, violating both whistleblower protection laws and v...
  • 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...
  • Pharmaceutical Manufacturer Sues FDA Over Use of Enforcement Discretion

    Minneapolis-based K-V Pharmaceutical has a problem: its flagship product, Makena, isn't maturing into the cash-generating product the company hoped it would become, leaving the company to face likely financial ruin if its cash-flow situation doesn't improve dramatically within the next few months. The company's hopes for dramatic change may rest squarely on the success of a lawsuit it filed on 5 June. Reuters reports the company has filed suit against the US Food and...
  • Agency Takes Aim at FDA in Whistleblowing Guidance

    A federal agency tasked with protecting whistleblowers has released a new guidance to other federal agencies urging them to "heed whistleblower rights when monitoring employee communications"-a warning seemingly directed squarely at the US Food and Drug Administration (FDA). FDA has been under investigation by various agencies and legislators since January 2012 after six former employees of its Center for Devices and Radiological Health filed suit in federal court allegi...
  • Supreme Court Prepares to Hear Amgen's Challenge to Securities Fraud Lawsuit

    • 12 June 2012
    The Supreme Court of the United States (SCOTUS) said it agreed to hear a challenge from life sciences manufacturer Amgen regarding a lawsuit alleging the company inflated its stock price by misleading investors about the safety of its anemia drugs, Aranesp and Epogen. Amgen is reportedly contesting the class-action nature of the lawsuit, which it says could have the perverse effect of placing severe financial pressures on companies if allowed to stand. "At issue," expla...
  • 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...
  • Judge: Regulatory Inspection Report Can Form Basis of Class Action Lawsuit

    In the long list of things that are inadvisable to regulatory professionals, making misleading statements to the authority in charge of regulating your business likely ranks near the top. Those found to have misled the US Food and Drug Administration (FDA) have in the past been publicly warned, fined, imprisoned, shut down and barred from participating in federal programs. Now KV Pharmaceuticals is facing the prospect of an additional action: a class-action shareholder l...
  • 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 ...
  • Bloomberg: J&J Sold Unapproved Medical Device for Years Prior to Approval

    Life sciences manufacturer Johnson & Johnson sold its now-controversial vaginal mesh implant for three years prior to being approved by the US Food and Drug Administration (FDA) in 2008, reports Bloomberg . The unauthorized sale of the Prolift vaginal mesh implant product, manufactured by Johnson & Johnson's Ethicon unit, could place the 510(k) approval pathway under additional scrutiny. The company marketed Prolift as early as 2005, reports Bloomberg , reason...