Last week the FDA made a bold move by requesting that Endo Pharmaceuticals remove its opioid pain medication, reformulated OPANA® ER (oxymorphone hydrochloride), from the market, stating the agency’s concern that “the benefits of the drug may no longer outweigh the risks.” This action – the first time the FDA has taken steps to remove […]
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A direct-to-consumer television ad for CONTRAVE (naltrexone HCI and bupropion HCI) made false or misleading statements about the risks of the product, according to the first 2017 Untitled Letter issued by FDA’s Office of Prescription Drug Promotion (OPDP) to Orexigen Therapeutics Inc. on May 18. The enforcement letter states that the ad, submitted to the […]
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May 31, 2017 – New FDA Commissioner Scott Gottlieb’s initial tasks largely will be administrative, according to Wayne Pines, healthcare president at APCO Worldwide and former FDA associate commissioner for public affairs, who spoke at a May 16 session of the Coalition for Healthcare Communication Rising Leaders Conference for Healthcare Policy, held in Washington, D.C. […]
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May 30, 2017 — In response to former FDA Commissioner Robert Califf’s recent call for the Coalition for Healthcare Communication to establish a code of ethics for members, several industry leaders on the CHC’s executive committee indicated that such a code strikes a responsive chord (see related article at http://www.cohealthcom.org/?p=3586). At the Coalition’s May 15 […]
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May 23, 2017 — By Coalition for Healthcare Communication Executive Director John Kamp Participants at last week’s Coalition for Healthcare Communication Rising Leaders Conference on Healthcare Policy in D.C. heard much about the possibility of price controls on our client’s products but did not find broad consensus on whether they might happen and what […]
Read moreMay 18, 2017 – At this week’s information-packed Coalition for Healthcare Communication’s Rising Leaders Conference, keynote speaker and former FDA Commissioner Robert Califf said that “healthcare marketers need to create a code of ethics to promote drugs for truthful and non-misleading uses outside their FDA-approved labels, commonly referred to as off-label promotion,” according to coverage […]
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By John Kamp, Coalition for Healthcare Communication Executive Director May 11, 2017 – Although no one seems to like the new Trump/Ryan healthcare bill, House staffers now (finally) are preparing for the next big Republican effort – overhauling the tax system for both individuals and corporations. Like healthcare, everyone seems to agree that an overhaul […]
Read moreMay 1, 2017 – Having cleared the Senate Committee on Health, Education, Labor and Pensions (HELP) with a 14-9 vote on April 27, Dr. Scott Gottlieb’s nomination to be the next FDA commissioner is now headed for a full Senate vote. So far, Gottlieb’s nomination has moved quickly and smoothly through the nomination process. “Gottlieb […]
Read more April 24, 2017 – There is no doubt that the Trump administration is likely to change health policy, but the questions that remain to be answered are exactly what those changes will be and how they will affect healthcare communication. If you want predictions and insight from a distinguished panel of FDA and policy experts, […]
Read more Coalition Commentary by Executive Director John Kamp April 17, 2017 — Agencies, media and clients all need to watch closely as this Congress looks to regulate medical manufacturers’ real or perceived excess profits, or at least bring down the cost of medical products for citizens. So far, the political heat on medicine companies has not […]
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