Media Mentions
2009
Robert Nicholas analyzed the Seventh Circuit's decision in U.S. v. Farinella in a May 8 Washington Legal Foundation Legal Opinion Letter. The decision held that the Food & Drug Administration cannot merely rely on its own assertion and opinion when claiming that food or drug labeling is misleading and in violation of the law. Mr. Nicholas concluded that "one can make a compelling argument based on Farinella that . . . both the [Food & Drug] Act and the Constitution demand more than an assertion by the FDA about what something means . . . without any authoritative support whatsoever."
, Health, Life Sciences & Medical Products, Life Sciences - Health
Robert Nicholas analyzed the U.S. Seventh Circuit's decision in United States v. Farinella for Health Lawyers Weekly (April 24). The decision rejected the Food & Drug Administration's assertion that "misleading" product labeling violates the "misbranding" provisions of federal law. Although the case related to a food product, Robert noted that it has "significant potential applications" for prescription drug and medical device advertising and promotion, where "the FDA often relies only on its own expertise in deciding what meaning to ascribe to otherwise ambiguous and undefined representations."
, Health, Life Sciences & Medical Products, Life Sciences - Health, Life Sciences - Medical Products & Technology
Robert Nicolas was quoted April 3 in Dickinson's FDA Webview concerning the Seventh Circuit Court of Appeals reversal in a jury conviction of a food manufacturer for misbranding food. The conviction had hinged on the FDA's unfounded assertion that a "best when purchased by" date was the same as an "expiration date" that could raise freshness or safety concerns for consumers. The attorney said that the FDA's interpretation lacked empirical support about the term's meaning, and added: "Surely the First Amendment demands at least some reliable extrinsic evidence . . . before FDA can simply assert, in the absence of any otherwise controlling authority, that consumers comprehend ambiguous advertising and labeling claims in the way the agency alleges."
, Health, Health - Product Regulation, Life Sciences & Medical Products
2008
Robert Nicholas and Paul Radensky’s article "FDA and Drug Advertising: No Attention Deficit On Nooed For 'Substantial Evidence'" appeared in the November 7 issue of the Washington Legal Foundations' Legal Backgrounder.
Paul W. Radensky M.D., Health, Life Sciences & Medical Products, Life Sciences - Health
McDermott's On the Subject "FDA Challenges Implied Outcomes Claims For Several ADHD Products: An Analysis" was featured in the October 17 issue of Health Lawyers Weekly.
, Health, Life Sciences & Medical Products, Life Sciences - Health
McDermott's On the Subject "FDA Confirms Its View on Generic Drug Label Carve-Outs" was featured on October 9 in Health Law360.
, Health, Life Sciences & Medical Products, Life Sciences - Health
McDermott Will & Emery's White Paper entitled "FDA Challenges Implied Outcomes Claims for Several ADHD Products: An Analysis" was featured in the Guest Column on October 3 in Health Law360.
Paul W. Radensky M.D., Health, Life Sciences & Medical Products, Life Sciences - Health
McDermott was mentioned in the October 2 issue of FDA's Webview in an article regarding the Firm's On the Subject discussing the letters issued by the U.S. Food and Drug Administration's (FDA) Division of Drug Marketing, Advertising, and Communications alleging that promotional material for certain products intended for use in treating attention deficit hyperactivity disorder (ADHD) made implied claims about an effect on ADHD "outcomes" that were not supported by "substantial evidence." FDA Webview notes, "Attorneys at McDermott...say FDA's Warning Letters and notices of violation to several manufacturers of ADHD drugs mean that drug companies wanting to avoid a challenge from CDER's Division of Drug Marketing, Advertising, and Communications (DDMAC) should review ad and promotional materials in all therapeutic categories to determine whether they make implied outcomes claims of the kind alleged by DDMAC in the ADHD letters."
Paul W. Radensky M.D., Conflicts of Interest - Health, Health, Life Sciences & Medical Products, Life Sciences - Health
Robert Nicholas was mentioned in the September 2008 issue of Innsight Industry Newsletter in an article discussing the FDA's view on generic drug-label carve outs.
, Health, Life Sciences & Medical Products, Life Sciences - Health
Robert Nicholas was mentioned in the August 22 issue of FDA'sWebview in an article regarding his recent On the Subject discussing the FDA's Camptosar® decision.
, Health, Life Sciences - Health
McDermott Will & Emery was mentioned in the July 2008 issue of DTC Insights – DTC Forecast in an article summarizing McDermott's recent White Paper on Merck settling the Vioxx Litigation with State Attorneys General.
Paul W. Radensky M.D., T. Reed Stephens, Health, Health Care Litigation, Life Sciences - Health
Robert B. Nicholas was mentioned in the June 16 issue of the National Law Journal in an article regarding a new U.S. Food and Drug Administration final rule governing clinical trials held in foreign countries that will spark painstaking legal review of pharmaceutical companies' protocols for trials. "Adhering to the FDA's good clinical practices directives for studies done abroad means more work for clients and their attorneys. We'll be working with companies trying to structure clinical studies that they'll be conducting outside the U.S.," Mr. Nicholas said.
, Health, Life Sciences - Health
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.
Jennifer S. Geetter, Paul W. Radensky M.D., Health, Life Sciences - Health
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.
Paul W. Radensky M.D., T. Reed Stephens, Health, Life Sciences - Health
Robert Nicholas was 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. Nicholas said.
, Health, Life Sciences & Medical Products, Life Sciences - Health
Robert B. Nicholas was quoted on April 14 by the National Law Journal in an article regarding the U.S. Food and Drug Administration's plan to post employees in the People's Republic of China. The FDA announced plans to post eight full-time, permanent FDA employees in China within the next 18 months, plus five local Chinese nationals to work with FDA staff. "A shift in China's regulatory regime for drugs, medical devices and foods isn't going to happen overnight, but its creation and development will create opportunities for lawyers working with U.S. and Chinese manufactures in China for many years to come," said Mr. Nicholas. "It takes knowledge, experience and training to get people to understand the consequences of how they prepare documents for contracts and for submission to various regulatory agencies," Mr. Nicholas added.
, Food and Drug Administration - Alcohol Regulatory & Distribution, Health
Robert Nicholas was 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. Nicholas said.
, Health
Robert Nicholas was 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. Nicholas said.
, Health
Robert Nicholas was quoted in the January 14 issue of Product Liability Law 360 in an article regarding the growing "cosmeceuticals" industry. "When you work with clients who have products they want to bring to the market, frequently the question they ask is, 'What’s the fastest way to get it to the market?' There is a trade-off between speed to market and exclusivity or safety. In the absence of a safety issue, the FDA doesn't tend to aggressively regulate cosmetics. That's one reason why it's an attractive area for manufacturers, even if you have legitimate claims of 'pharmaceutical' results," Mr. Nicholas said.
, Health, Health - Product Regulation
2007
Robert Nicholas was quoted in a June 7 article published by The GMP Letter regarding the Form 483s and warning letters. "Firms should not be afraid to disagree with the FDA regarding inspectional observations cited in Form 483s and warning letters. The 483 or the warning letters are really FDA's observations. In fact, sometimes they're wrong," Mr. Nicholas said.
, Health
2005
Robert Nicholas was quoted in the June 23 issue of The Boston Globe in an article addressing medical device companies' procedure on product recalls.
, Health
Robert Nicholas was quoted in the Boston Globe on March 2 regarding the FDA asking Congress to give it more powers to dictate the warnings on drug labels. The FDA has strong authority to dictate labeling language before a drug is approved. "Once a product is on the market, it's like a property right," commented Bob. The FDA still has negotiating clout because if a drug company refuses its suggestions the agency could initiate legal proceedings to remove the drug from the market or it could ask the secretary of the DHHS to declare a drug an imminent hazard. "There are lots of informal rules -- there is jawboning and discussions," Mr. Nicholas said.
, Agribusiness, Food & Beverage
2002
Robert Nicholas was quoted in the October 7 issue of Food Chemical News regarding the FDA Commissioner candidate Mark McClellan. Mr. Nicholas mentioned that the scheduling of Mr. McClellan's confirmation hearing in the Senate, prior to the November election, exemplifies that Congress recognizes the need for a full-time leader at the FDA.
Robert Nicholas was quoted in the March 11 issue of Food Chemical News in regarding the possible appointment of Lester Crawford as the chief of the FDA.
