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The Atlantic: Finding the Right Industry-Physician Relationship Advances Medicine

May 20, 2013 – Although relationships between the pharmaceutical industry and physicians have come under greater scrutiny as the implementation ... read more

WLF to CMS: Deem Medical Textbooks Educational Materials or Face Potential First Amendment Challenge

May 16, 2013 – The Centers for Medicare & Medicaid Services (CMS) is likely “to find itself the target of ... read more

Kamp in MMM: Off-label Is on the Table

May 14, 2013 — In a Medical Marketing and Media (MMM) column posted May 1, Coalition for Healthcare Communication Executive ... read more

Many Physicians Are Both Unaware and Wary of Sunshine Act Requirements, Survey Says

May 6, 2013 — With Sunshine Act reporting slated to begin in less than three months, it is sobering to ... read more

Senate Commerce Committee Growing Impatient with Self-regulatory Measures

April 29, 2013 – Although the Digital Advertising Alliance (DAA) has made great strides to protect consumers’ privacy online – ... read more

Coalition: Educational Materials Should Be Excluded from Sunshine Reporting

April 22, 2013 – In April 18 comments to the Centers for Medicare & Medicaid Services (CMS) the Coalition for ... read more

White Paper Examines FDA Enforcement in Digital, Social Media Realm

April 4, 2013 – A new White Paper, “FDA Communications Oversight in a Digital Era,” issued April 2 by Eye ... read more

Policy and Medicine: News Outlets Accentuate the Negative in Describing Industry-Physician Relationships

April 4, 2013 — Headlines run by news outlets regarding the status of industry-physician relationships rarely focus on the benefits ... read more

Kamp Commentary: Supreme Court Decision Could End “Pay for Delay,” Hurt Patent Protection

April 1, 2013 – By John Kamp, Executive Director, Coalition for Healthcare Communication While not directly about communication and marketing, ... read more

Promotion Down, But Prospects Up for New Drugs

March 22, 2013 – Although spending on drug promotion has declined in recent years,  2013 could be a pivotal year ... read more

“Cyberspace Is Not Without Boundaries,” FTC States in Digital Advertising Guidelines

March 19, 2013 – Although the FDA has not yet issued its long-awaited social media guidance for the biopharma industry, ... read more

NDHI Releases Statement Outlining Four Principles for Industry/Provider Collaborations

March 11, 2013 – Healthcare industry collaborations with physicians and researchers have “been at the heart of most of the ... read more

Study Cites Benefits of Pharma’s Promotional Efforts

March 4, 2013 – A recent study released by the National Bureau of Economic Research (NBER) states that although consumer-directed ... read more

CMS Launches "OpenPayments" Site as Part of Sunshine Implementation

Feb. 25, 2013 – The Centers for Medicare & Medicaid (CMS) launched its “OPENPAYMENTS” Website last week, which will be ... read more

Sunshine Act Final Rule: Coalition for Healthcare Communication Summary

On Feb. 1, the Centers for Medicare & Medicaid Services (CMS) issued a final rule implementing the Sunshine Act provisions ... read more

Sunshine Act Final Rule Resets Clock on Annual Reporting of Payments to Physicians

Many Questions Still Unresolved Feb. 4, 2013 – Although the final rule to implement the Sunshine provisions of the Affordable ... read more

Coalition’s Policy Update: Keep Fiscal Challenges, Privacy Regulation on Radar

Jan. 15, 2013 – If 2012 – with its high number of new drug approvals, senior staff stability within the ... read more

OPDP Untitled Letters on PR Materials Surprise Industry

Nov. 27, 2012 – An Oct. 31 enforcement letter from the FDA’s Office of Prescription Drug Promotion (OPDP) to Cornerstone ... read more

DAA’s Self-regulatory Ad Program to Protect Consumers Online Is Praised by White House, DOC and FTC

 Feb. 23, 2012 – At a White House meeting held today to unveil the blueprint for the Obama Administration’s “Consumer ... read more

Sorrell v. IMS: What Marketing Professionals Need to Know

By John Kamp, Executive Director, Coalition for Healthcare Communication July 18, 2011 — For those who have not read the ... read more

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Risk Communication Advisory Committee to Discuss Communicating Uncertainty, Multiple Risks

June 26, 2012 – The FDA’s Risk Communication Advisory Committee is meeting Friday, June 29, to discuss recent research on communicating and understanding uncertainty, as well as

risk perception in low-income populations with multiple risks.

According to discussion topics for the meeting issued by the agency, the RCAC would like to get answers to the following questions:

  • Is it important to specify the source(s) of uncertainty in a communication?
  • Should the FDA specify the type(s) of uncertainty?
  • What points should be emphasized on in message development to increase transparency and build trust in FDA’s communication of uncertain information, without overwhelming the audience with detailed caveats?
  • Does the material presented at the meeting or other data suggest points for the FDA to consider about what uncertainty information patients or the general public need to know, and conversely, whether there is risk of undermining trust or confidence in FDA communications by providing more uncertainty information?
  • Discussions at previous meetings highlighted the point that different people may interpret descriptions like “rare” or “serious” quite differently and that evaluative descriptions can be quite helpful. What points should the FDA bear in mind, to communicate clearly to the varied public, again given that we must provide a message to all?
  • What points should help the FDA in developing communications that facilitate the sort of emotional worry and sense of efficacy that would support deeper, more systematic cognitive use of the

    information? At the same time, how can the FDA accomplish such communication to inform the members of the public who need it while not causing undue worry for others?

  • What types of messages, language or tools can the FDA use to more effectively target minorities, the economically disadvantaged, and the less educated?

The RCAC meeting will be held at FDA’s White Oak Campus (10903 New Hampshire Avenue., Bldg. 31, Conference Center Room 1503, Silver Spring, MD), from 8 a.m. to 3:30 p.m. The meeting also can be viewed remotely by logging on to: https://collaboration.fda.gov/rcac/.