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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 ArticleProPublica Reporters Urged to Provide Context and Meaning to Payment Disclosures
Sept. 8, 2011 – As ProPublica and its media partners roll out their reports today on industry payments to physicians, doctor and industry groups are urging reporters to include significant contextual...
View ArticleFall 2011 Update: Four Things Industry Should Know
By John Kamp, Coalition for Healthcare Communication Executive Director Sept. 13, 2011 — Debates over health care and related marketing costs are certain to arise as the Congress and White House...
View ArticlePrevisionPolicy Eyes Spending Shifts from Sunshine Act; Industry Coordinating...
Dec. 22, 2011 – As industry groups focus on the details of last week’s proposals from HHS to implement the Sunshine Act provisions of the Affordable Care Act, veteran journalist Cole Werble in...
View ArticleDigital Health Coalition Issues Guiding Principles and Best Practices to Help...
Feb. 7, 2012 – Responding to patient and professional calls for more industry participation in the Internet and social media, a broad-based industry group – including the Coalition for Healthcare...
View ArticleFDA Draft Guidance on DTC TV Ads Raises Important Questions
By John Kamp April 9, 2012 – The only thing really clear about the new guidance on pre-review of the DTC advertising is that advertisers and their marketing agency partners will need to ensure that...
View ArticleProposed OTC Drug Distribution Would Expand Patient Access to “Rx” Drugs
April 30, 2012 – Comments are due May 7 on an FDA-proposed paradigm that would allow the agency to approve certain drugs – that would otherwise require a prescription – for over-the-counter (OTC)...
View ArticleFDA Looks to Consumers for Pre-approval Input
May 23, 2012 – At an FDA meeting held last week to explore more effective ways of including patient input in regulatory decisions regarding drug, device and biological products, the agency made it...
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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...
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 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 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 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 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 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 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 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 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 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...
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