31 January 2012, Open Letter To: Kathleen Sebelius, Secretary of Health and Human Services – Kathleen.Sebelius@hhs.gov Subject: Rescind approval of Gardasil® due to lack of efficacy during post-licensure monitoring Dear Ms. Sebelius: The quadrivalent human papillomavirus (HPV) vaccine, Gardasil® was approved for marketing as a drug to prevent cervical cancer under the fast track drug […]
Rule Changes Proposed for Research on Humans
By Andrew Pollack The government is proposing sweeping changes in the rules covering research involving human subjects, an effort officials say would strengthen protections while reducing red tape that can impede studies. The officials said the changes were needed to deal with a vastly altered research climate, whose new features include genomics studies using patients’ […]
U.S. Effort to Remove Drug CEO Jolts Firms
By Alicia Mundy A government attempt to oust a longtime drug-company chief executive over his company’s marketing violations is raising alarms in that industry and beyond about a potential expansion of federal involvement in the business world. The Department of Health and Human Services this month notified Howard Solomon of Forest Laboratories Inc. that it […]