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New Hampshire Amends Patient Privacy Law Following IMS v. Sorrell Decision

May 11, 2012 — In the wake of the June 2011 U.S. Supreme Court decision in IMS v. Sorrell, which ... read more

CMS: Sunshine Act Data Collection Will Be Delayed Until 2013

May 7, 2012 — The Centers for Medicare & Medicaid Services (CMS) stated on the CMS blog that following its ... read more

Guest Column: Heavy Meddle by Peter Pitts

May 7, 2012 — The American Recovery and Reinvestment Act (aka, “the stimulus package”) provided AHRQ with $29.5 million for ... read more

Proposed 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 ... read more

PDUFA V Bills Moving Forward Without Specific Marketing Provisions

April 23, 2012 — The House and Senate both issued draft legislation last week to reauthorize the Prescription Drug User ... read more

CHC and TAC Comments Object to “Dual Modality” Risk Communication in DTC TV Ads

April 16, 2012 – The Coalition for Healthcare Communication (CHC) and The Advertising Coalition (TAC) recently told the FDA’s Office ... read more

ACRE Study Finds Medical Journal Discussion of Academic/Industry Relationships Unbalanced

April 12, 2012 – The Association of Clinical Researchers and Educators (ACRE) announced yesterday the publication of a study in ... read more

FDA Draft Guidance on DTC TV Ads Raises Important Questions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 ... read more

FTC to Industry: Adopt Consumer Privacy Best Practices Now

March 28, 2012 – Industry members needing another reason to join the fray of companies participating in the Digital Advertising ... read more

Call for Industry Comments: Proposed FDA Study on “Corrective” DTC TV Advertising

March 26, 2012 – Note to Industry Leaders The Coalition for Healthcare Communication needs your input on a study FDA ... read more

New Video Highlights Advances in CME Conflicts of Interest Policies

March 19, 2012 – A new video produced by CME Peer Review – “Conflict of Interest: The Bottom Line” – ... read more

FDA Draft Guidance on DTC TV Ads Identifies Campaigns Subject to 45-day Pre-Review Process

March 13, 2012 – Draft guidance released today by the FDA – “Guidance for Industry Direct-to-Consumer Television Advertisements” – calls ... 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

Coalition Calls for Substantial Revisions to Sunshine Act Proposed Rules

Feb. 16, 2012 – Further notice and comment are necessary for the implementation of Section 6002 of the Affordable Care ... read more

Digital Health Coalition Issues Guiding Principles and Best Practices to Help Lead Way on Robust Use of Social Media by Medicine Companies

Feb. 7, 2012 – Responding to patient and professional calls for more industry participation in the Internet and social media, ... read more

Digital Advertising Alliance Launches Consumer Education Campaign

Jan. 27, 2012 – The Digital Advertising Alliance (DAA) last week launched its “Your AdChoices” public education campaign to inform ... read more

MMM: CME Video Addresses Conflict of Interest

Jan. 26, 2012 – Avoiding conflict of interest in continuing medical education (CME) may seem like a daunting task, but ... read more

Does Novo Nordisk’s Victoza + Paula Deen = Recipe for Success?

Jan. 20, 2012 – Common sense should tell people that some of celebrity chef Paula Deen’s infamously unhealthy dishes – ... read more

Sunshine or Rain?

By Jack E. Angel, Education Foundation Executive Director, Coalition for Healthcare Communication Jan. 17, 2012 – The Affordable Care Act ... read more

MMM Features Kamp’s Call for Industry Leadership on Off-label, Online Communications

 Jan. 6, 2012 — This article, written by Coalition for Healthcare Communication Executive Director John Kamp, was featured in the ... read more

FDA Issues Draft Guidance on Unsolicited Off-label Info Requests, Addresses both Professional and Internet Media

Jan. 2, 2012 – In the waning days of 2011, the FDA released a significant draft guidance on company responses to ... read more

FDA Approval Report Contains Good News for Patients and Industry

  By John Kamp, Executive Director, Coalition for Healthcare Communication – Nov. 7, 2011 – Until the research labs and ... read more

RPM Report: Pandora’s Box Officially Open as New Legal Challenges to FDA’s Off-label Restrictions Emerge

Oct. 24, 2011 – After the U.S. Supreme Court struck down speaker- and content-based restrictions in Sorrell v. IMS Health, ... read more

Par Pharma Case Asserts That First Amendment Protects Truthful Off-label Speech

Oct. 18, 2011 – A case filed by Par Pharmaceutical, Inc. against the FDA seeks to preserve Par’s First Amendment ... read more

Kamp on the Sunshine Act: Collaboration Key to Patient Care

Dec. 14, 2011 — UPDATE — CMS has published the proposed rules enforcing the Sunshine provisions of the Affordable Care ... read more

Experts Weigh In on Implications of Sorrell Decision

Aug. 1, 2011 — The recent Supreme Court decision in Sorrell v. IMS Health Inc. is earning robust commentary in ... read more

Academic 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 ... 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

Kamp Column: Industry Must Embrace Internet and Social Media or Become Irrelevant in Many Health Conversations

By John Kamp, Executive Director, Coalition for Healthcare Communication June 29, 2011 — Yesterday I had the pleasure of moderating ... read more

PhRMA 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 ... read more

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Report Shows That Doctors and Patients Benefit Greatly From Commercially Supported CME

View the report

FDA Draft Guidance: Coalition Submits Formal Comment

Coalition submits formal comment on FDA Draft Guidance on “Presenting Risk Information in Prescription Drug and Medical Device Promotion”.

The coalition’s comment, which commends the draft’s many strong points, also criticizes what they believe is the FDA’s over complication of advertising and promotion.

Read the full comment

Coalition Asks Senate to Focus on Patient Access to Care

Coalition tells Senate committee that real patient interests trump potential “conflicts of interest” as nation expands access to care.

Read the Coalition’s letter

View related press release

DTC and Medical Marketing — Tax Issues

From DTC Perspectives:

Representatives John Fleming and Frank Pallone set Erin Burnett of CNBC straight on the value of DTC and why removing its tax deductibility is not a good idea.

View the article on their website

The DTC Fight Is Far From Over

Washington lobbyists working with the Advertising Coalition breathed a bit easier Friday when learning that the Ad Tax Provision was not likely to be in the House revenue options for funding healthcare reform. But watch the news carefully.

Advocates Sound the Alarm Over Congress’s Threats to Tax Drug Advertising

The Advertising Coalition and the AAAA D.C. office report that elimination of the tax deduction for marketing costs for drug and related businesses is still among the revenue options to pay for healthcare reform (HCR).

FDA Draft Guidance: Potentially a Significant Danger

The Coalition has developed an aggressive plan to address the FDA’s recent “draft guidance” for including risk information in advertising and other marketing materials.

Under the leadership of Harry Sweeney, the Coalition has developed an aggressive plan to address the FDA’s recent “draft guidance” for presenting risk information in advertising and other marketing materials.

Coalition Defends Use of Rx Data

Read the Coalition’s Amici Brief, submitted to appeals court, defending marketing use of prescription data and asserting First Amendment rights.

View the Brief

4A’s Urges President and Congress to End Efforts to Remove Drug Ad Deductibility

The American Association of Advertising Agencies, along with other members of The Advertising Coalition, are aggressively opposing all efforts to restrict the deductibility of prescription drug advertisements. The deductibility proposal, which has been discussed in Congress and at The White House, is an area of a new revenue package being considered as part of a new healthcare reform.

The Advertising Coalition, of which the 4A’s is a founding member, is coordinating the industry’s efforts to defeat any changes to the deductibility rules. The broad coalition comprises marketers, clients and media outlets.

Download the Letter Sent by The Advertising Coalition to President Obama

“This is a very real and an extremely serious threat,” said Dick O’Brien, head of the 4A’s Washington office. O’Brien and other 4A’s staff and members with medical accounts have been meeting with Congressional leaders and key members of the House Ways and Means Committee and the Senate Finance Committee to educate them about the effect such a change would have on consumers and on marketers and media.

For more information about the 4A’s efforts, contact the 4A Washington office, 202-331-7345.

AMA Rejects Ethics Proposal to Limit Industry Collaboration

June 15, 2009 — Today the American Medical Association (AMA) House of Delegates rejected sweeping ethical guidelines against industry collaboration. The guidelines would have suppressed many education and marketing relationships with practicing doctors and medical researchers.

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