What Medical Marketers Can Expect from President Trump, Republican-led Congress
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...
View ArticleIndustry Peacekeeping with President Trump Holds Promise But Portends Danger
By John Kamp, Executive Director, Coalition for Healthcare Communication [Editor’s Note: This “The Final Word” column appeared in the February 2017 edition of MedAdNews and is reprinted with...
View ArticleCitizen Petition Calls on FDA to Stay Final Rule Establishing “Totality of...
Feb. 24, 2017 – The FDA recently published a final rule on intended use and adequate directions for use that establishes a not-previously-announced “totality of the evidence” standard and is in...
View ArticleFDA Appears Subject to Some Exemptions from Hiring Freeze
Feb. 13, 2017 – A memo sent to Department of Health and Human Services (HHS) division heads last week from HHS Acting Deputy Secretary Colleen Barros attempts to better define exemptions from the...
View ArticleFDA Will Study Consumer and HCP Ability to Identify Deceptive Drug Promotion
Jan. 4, 2017 – The FDA will examine whether consumers and health care professionals (HCPs) can identify deceptive claims in prescription drug promotion, according to a notice published in today’s...
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PLOS Drug Marketing Study: Behind the ugly headlines
By John Kamp, Executive Director, Coalition for Healthcare Communication While the headlines cite implausible rates of non-compliance with FDA marketing regulations, a close reading of the recent PLOS...
View ArticleCoalition to Host ‘Rising Leaders’ Conference in May
March 28, 2016 – To further educate and integrate the up-and-coming leaders in the healthcare communication industry, the Coalition for Healthcare Communication is hosting a conference May 11 that will...
View ArticleKaiser Poll: DTC Ads Have High Profile, But Mixed Reviews
Oct. 30, 2015 – The drug industry may have additional work to do to improve the public’s perception of its advertising, according to Kaiser Health Tracking Poll findings reported Oct. 28. Although a...
View ArticleCoalition Panel: Data Regulation Focus Shifting from Privacy to Security
Sept. 29, 2014 – The federal government’s efforts to severely limit the ability of industry to gather and use online data have shifted away from data privacy and toward data security, according to...
View ArticleFTC Calls for Data Broker Legislation To Protect Consumers
May 29, 2014 – The Federal Trade Commission (FTC) released a report May 27 in which it asks Congress to consider legislation that would require data brokers to provide consumers with access to their...
View ArticleDale Cooke: New Product Name Placement Draft Guidance Rights Wrongs from 2012...
Nov. 25, 2013 – The FDA published a Federal Register notice (2013-27770 (1)) on Nov. 20 regarding the availability of new draft guidance on product name placement, size and prominence in advertising...
View ArticleFDA Mobile App Guidance Focuses on Risk, Calls for “Enforcement Discretion”
Sept. 30, 2013 – Pharmaceutical companies that develop mobile applications should pay close attention to the details and examples listed in the FDA’s final guidance on mobile medical applications...
View ArticleFDA to Healthcare Professionals: Help Us Find “Bad Ads”
April 29, 2011 – In a Webinar yesterday, the U.S. Food and Drug Administration’s (FDA’s) Division of Drug Marketing, Advertising, and Communications (DDMAC) reminded medical marketers of its continued...
View ArticlePhRMA Survey Shows That Physicians Value Industry Communication
March 31, 2011 — At a time when interaction between biopharmaceutical companies and physicians is under increased scrutiny, a recent physician survey indicates that a majority of physicians find...
View ArticleMore Social Media Studies Planned at FDA
Immediate Guidance Slips Again May 9, 2011 – A recent notice in the Federal Register calling for comments on a series of Food and Drug Administration (FDA) studies to determine the most effective way...
View ArticleFormer FDA Policy Chief Says Consumer Group Request Would Slow Drug Approvals
June 16, 2011 – The Food and Drug Administration (FDA) should not mandate comparative effectiveness trials as part of the drug approval process, according to Scott Gottleib, a resident fellow with the...
View ArticleRequired Course for Medical Agencies: 4A’s Webinar on Your Role in...
May 17, 2011 — Widespread industry participation in online behavioral advertising (OBA) self-regulation is the only way for the program to succeed and for advertisers to stave off federal regulation of...
View ArticleAcademic Detailing and Health Plan Communications: Is the Playing Field Level?
By Kenneth P. Berkowitz, Esq. July 21, 2011 — Why does the government fail to apply current regulatory requirements and rules to health plans and academic detailing? For some time now, many in the...
View ArticlePitts: BIO’s Call for Drastic Regulatory Change Is On Point
Pitts: BIO’s Call for Drastic Regulatory Change Is On Point June 27, 2011 — In a recent blog entry on DrugWonks.com, Peter Pitts commended BIO’s proposals to revamp the U.S. regulatory system for new...
View ArticleCaronia Decision May Force FDA & DOJ to Alter Drug Marketing Regulations
Jan. 28, 2013 – Although the U.S. Court of Appeals for the Second Circuit decision in U.S. v. Caronia found truthful but off- label communication between a drug representative and a doctor to be...
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