Media Mentions
2008
Jason Lief, Arnold Friede and Robert Nicholas were mentioned in the August 22 issue of FDA'sWebview in an article regarding their recent On the Subject discussing the FDA' Camptosar® decision.
Arnold I. Friede, Jason A. Lief, Robert B. Nicholas, Health, Life Sciences - Health
Arnold I. Friede was mentioned in the July 21 issue of The Pink Sheet in an article regarding the increased influence the Accreditation Council for Continuing Medical Education (ACCME) will have under PhRMA's revisions to its code on interactions with health care professionals. "Most of the companies are even ahead of where the code is and have been moving very aggressively over the last many years," Mr. Friede said. "Under the PhRMA code the companies may not suggest content; under ACCME proposals, companies would be foreclosed from even suggesting topics."
Arnold I. Friede, Health, Life Sciences & Medical Devices, Life Sciences - Health
Arnold Friede, Jennifer Geetter, Robert Nicholas, and Paul Radensky had their On the Subject published in the May 30 edition of Health Law 360 regarding the FDA Draft Guidance on certification of compliance with the new FDAAA clinical trial registration and posting regime.
Arnold I. Friede, Jennifer S. Geetter, Robert B. Nicholas, Paul W. Radensky M.D., Health, Life Sciences - Health
Arnold Friede, Elizabeth Hack, Robert Nicholas, Paul Radensky and T. Reed Stephens were mentioned in a May 29 article in FDA Webview regarding the recent White Paper they had authored regarding Merck’s $58 million settlement of consumer fraud claims by state attorneys general.
Arnold I. Friede, Elizabeth I. Hack, Robert B. Nicholas, Paul W. Radensky M.D., T. Reed Stephens, Health, Life Sciences - Health
Arnold Friede was mentioned in the May 8 issue of Rx Compliance Report in an article regarding challenges facing DTC advertising. “A consensus gradually emerged about the need for a robust FDA prior DTC review program. The hope was that stronger FDA oversight would itself act both as a further deterrent, while at the same time, safeguarding against any massive civil penalty for DTC violations,” Mr. Friede said.
Arnold Friede was quoted in the May 7 issue of Medical Devices Law & Industry in an article regarding the FDAAA Clinical Trial Certification requirements. "The draft guidance is helpful but it leaves as many questions unanswered as it does answer. Additionally, the draft guidance is ambiguous about whether certifications are required for compassionate use INDs involving more than one patient," Mr. Friede said.
Arnold I. Friede, Health, Life Sciences - Health
Arnold Friede and Robert Nicholas were quoted in the April 2008 issue of Medical Marketing and Media regarding scientific 'free speech' being threatened. "Calls for an investigation into support for the American Heart Association (AHA) and American College of Cardiology stating are likely to convince other scientific groups not to speak out on issues of public concern," Mr. Friede and Mr. Nicholas said.
Arnold I. Friede, Robert B. Nicholas, Health, Life Sciences & Medical Devices, Life Sciences - Health
Arnold Friede and Robert Nicholas were mentioned in the April 2008 issue of Medical Marketing & Media (MMM) Online in an article regarding calls for investigation into support for the American Heart Association (AHA) and American College of Cardiology. "No one can question the status of the AHA and American College of Cardiology as scientific speakers in the debate about some of the most important public health issues of our time, even if they receive some financial support from commercial interests," Mr. Friede and Mr. Nicholas said.
Arnold I. Friede, Robert B. Nicholas, Health
Arnold Friede was mentioned in the March 31 issue of Legal Times regarding his move from Pfizer as senior corporate counsel to counsel in McDermott's Health Law Department based in the Washington, D.C. office.
Arnold Friede was mentioned in the February 2008 issue of DTC Insights regarding his recent move from Pfizer as senior corporate counsel to counsel in McDermott's Health Law Department in Washington, DC.
Arnold Friede was mentioned in the February 22 issue of RxCompliance Report in an article regarding the FDA draft guidance on industry dissemination of medical or scientific journal articles and how the guidance will impact the current enforcement frenzy surrounding off-label promotion. "No matter how liberal or restrictive the underlying FDA criteria for permissible dissemination of off-label journal articles by drug and device manufacturers, the FDA draft guidance does not address whether and how compliance with the states criteria would insulate manufacturers from liability under other statutes such as the False Claims Act," Mr. Friede said.
Arnold Friede and Robert Nicholas were quoted in the February 22 issue of FDA Webview in an article regarding the statements issued by the American Heart Association and the American College of Cardiology regarding the results of the Vytorin ENHANCE study. "Given the core First Amendment value of scientific speech by AHA and ACC about the ENHANCE study results, and their unquestionably sensible— benign —recommendation that patients speak with their doctors before precipitously stopping Vytorin, the fact that they have become objects of congressional investigations and have even been asked to name names about the preparation of their respective statements, suggests that there is a chill wind on free speech blowing from Capitol Hill," Mr. Friede and Mr. Nicholas said.
Arnold I. Friede, Robert B. Nicholas, Health
T. Reed Stephens and Arnold Friede were quoted in the February 22 issue of Rx Compliance Report in an article regarding the FDA draft guidance that was issued regarding industry dissemination of medical or scientific journal articles. "It seems entirely probable that enterprising plaintiffs, particularly qui tam whistleblowers, are unlikely to defer to FDA's draft guidance in determining whether certain manufacturer conduct provides a potential basis for False Claims Act liability," Mr. Friede said. "Plaintiffs must push the envelope with state law consumer protection theories as an end-run around FDA's guidance," Mr. Stephens added.
Arnold I. Friede, T. Reed Stephens, Health, Life Sciences - Health
