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 plain to patients, caregivers, patient advocates and patient advocacy groups that it wants patient perspectives to be included in the process. “This […]
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regulationDetermining Compliance with FDA Ad Rules Is Difficult
Sept. 16, 2011 – Trying to assess industry adherence with FDA advertising and promotion regulations is a tricky endeavor, according to an article posted today in Policy and Medicine. The article, “Study Shows Adherence to FDA Advertising Guidelines Are in the Eye of the Beholder,” states that although there currently is no “systemic assessment of […]
Read morePitts: 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 treatments and therapies. Pitts mentions that BIO’s plans, as reported in BioCentury, include a progressive approval pathway for unmet condition therapies, […]
Read moreFormer 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 American Enterprise Institute for Public Policy Research (AEI). Gottleib, a former FDA policy head, writes in AEI’s June issue of Health Policy Outlook […]
Read moreMore 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 of presenting risk information online indicates that the FDA is still a long way from developing significant new social media guidance. This status […]
Read moreFDA 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 actions to enhance surveillance and monitoring of industry marketing by urging physicians and other healthcare professionals to report any potentially misleading marketing activities to DDMAC. Although the year-old program has resulted in only […]
Read moreCMS "Sunshine Act" Stakeholders Call Set for March 24
Announcement Sends Ominous Signal to Industry Stakeholders March 18, 2011 — The Centers for Medicare & Medicaid Services (CMS) has given the industry its first glimpse of how it will implement the national registry of payments to doctors by sending a notice of a stakeholders’ call for next week, and the glimpse is not encouraging. Sounding like CMS wants more […]
Read moreFederal Regulators Send Clear Message to Digital Marketers: Self-regulate Now or Be Regulated
March 11, 2011 — As the public debate over digital privacy continues, federal regulators on and off Capitol Hill are telling online marketers that now is the time to widely adopt strict self regulatory programs that enable Web users to opt-out of unwanted tracking and marketing. If not, marketers can expect legislation and/or regulation by […]
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Coalition Focus for 2011
Coalition Focus for 2011
Although 2011 brings political party shifts in Congress and new challenges, the mission of the Coalition for Healthcare Communication (CHC) remains the same: To protect, for society and individual patients, the benefit of the free flow of healthcare information. This year the CHC will be focusing on four major issues: (1) tax treatment of marketing […]
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Add Your New Year Predictions to Our Industry Leaders'
Add Your New Year Predictions to Our Industry Leaders'
2011 Medical Marketing Predictions published in Medical Marketing & Media, December 30, 2010 — by Matthew Arnold Will 2011 be the year FDA loosens up and opens the floodgates on a flurry of big new approvals? More seriously, will they get around to issuing social media guidance for pharma before Baby New Year morphs into […]
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