• Blockbuster Asthma Drug Singulair Receives Generic Competition

    Generic versions of Merck's pharmaceutical blockbuster Singulair (montelukast sodium) are now available to consumers, making it the latest product to fall off the so-called 'patent cliff,' the US Food and Drug Administration (FDA) announced on 3 August . The drug is used by asthma and allergy sufferers to reduce inflammation, and was Merck's most lucrative, bringing in sales of up to $5 billion per year . The company is expected to lose much of its market share to its ...
  • FDA's 'Bad Ad' Program Marks Second Year of Operation

    The US Food and Drug Administration's (FDA) Bad Ad Program, an effort to encourage physicians and other healthcare providers to report "suspected untruthful or misleading prescription drug promotion," is doing some advertising of its own. In a "Year End Report" released this week, FDA's Office of Prescription Drug Promotion (OPDP) said it spent "significant time and resources" during the second year of the program's inception to increase the exposure of the Bad Ad progra...
  • Group to FTC: Merck's Marketing Tie-ins Violate Advertising Regulations

    • 21 June 2012
    Merck & Co might be wishing it had just stuck with Antonio Banderas to market its allergy products. In a sharply-worded letter to the US Federal Trade Commission, a group of public advocacy groups is demanding the agency investigate Merck's use of Dreamworks Animation's characters from the movie Madagascar III: Europe's Most Wanted to market its over-the-counter (OTC) Children's Claratin. "Dreamworks licensed its Madagascar characters for use on a number of child...
  • House Goes After Pharmaceutical Companies, Seeking Info on PPACA Negotiations

    • 08 May 2012
    An investigation by the US House Energy and Commerce Committee that began in January 2012 continues to escalate, with members of the committee directly targeting pharmaceutical companies in an attempt to discover what went on between the Obama administration and the pharmaceutical industry during negotiations on the Patient Protection and Affordable Care Act in 2010, reports Bloomberg . Members of the House Energy and Commerce Committee oversee the healthcare sector, ...
  • Merck Settles Vioxx Criminal Charges With US for $322 Million

    US pharmaceutical manufacturer Merck & Co. has settled criminal charges over the company's marketing of its painkiller drug Vioxx, reports Bloomberg . Merck will pay a $321.6 million criminal fine after US District Judge Patti Saris approved the settlement. This fine is in addition to a $628.3 million in civil claims paid out in November 2011, reports The Philadelphia Inquirer . Merck was charged with promoting Vioxx, a rheumatoid arthritis drug, illegally despite...
  • FDA Guidance on Veterinary Antibiotic Use Prompts Compliance, Criticism

    Shortly after the US Food and Drug Administration (FDA) released new rules to curtail the "injudicious" use of antibiotics in food-producing animals , three pharmaceutical manufacturers said they were agreeing to change the labeling on their veterinary antibiotics to exclude indications for food-producing animals, reports Bloomberg . FDA Deputy Commissioner for Foods Michael Taylor said he has assurances from Pfizer Inc., Eli Lilly & Co. and Merck & Co.-three o...
  • Merck Gets Warning Letter After Failing to Complete Postmarketing Safety Study

    Merck Sharp and Dohme Corp.'s global director of regulatory affairs received a warning letter on 17 February from the US Food and Drug Administration warning Merck that it had failed to complete an agreed-upon postmarketing study for its diabetes medications Januvia and Janumet. The products are now effectively misbranded under the Federal Food, Drug and Cosmetic Act (FD&C Act), and the company faces $250,000 in fines, with further fines accruing for continuing vi...