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FDA Draft Guidance on DTC TV Ads Raises Important Questions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FDA Draft Guidance on DTC TV Ads Identifies Campaigns Subject to 45-day Pre-Review Process

March 13, 2012 – Draft guidance released today by the FDA – “Guidance for Industry Direct-to-Consumer Television Advertisements” – calls ...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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NEWS ALERT: U.S. Supreme Court Deems Vermont Marketing Ban To Be in Violation of First Amendment

June 23, 2011 — In a victory for data gathering companies, the pharmaceutical and biotechnology industries, advertising agencies, medical publishers and other media, the U.S. Supreme Court ruled in Sorrell v. IMS Health Inc. today that Vermont’s ban on marketing use of prescription data “turns on nothing more than a difference of opinion” and that the state’s justifications for imposing “content- and speaker-based burdens on protected expression” do not withstand “heightened scrutiny.”

The Supreme Court’s 6-3 decision in favor of IMS (No. 10-779), followed oral arguments presented April 26, during which the Justices signaled that Vermont’s law was an attempt by the state to manipulate the “marketplace of ideas” on behalf of ideas favored by the state while restricting the rights of pharmaceutical companies to target doctors with truthful messages.

“This is a victory for patients as well as industry,” said John Kamp, executive director of the Coalition for Healthcare Communication. “Although couched in terms of privacy and cost reduction, the Vermont law was a transparent attempt to censor industry speakers while enabling government and others to speak. Enlightened policy makers always knew it was a bad idea. Now, it’s clear that the ban is also a violation of the First Amendment,” he said.

“Patients are not served by censorship. Without good data, no one can make informed decisions, including doctors, patients, policy makers and industry,” Kamp continued. “This and similar state statutes were direct attacks on data gathering, analytics and use. Let’s hope the proponents of these statutes find better ways to advance their policy goals.”

Indeed, the Supreme Court’s opinion states that Vermont “may not burden protected expression in order to tilt public debate in a preferred direction.”

Entities that either joined or supported IMS in this case also are pleased with the outcome. “We have long maintained that Vermont’s prescriber data restriction law – and others like it – violate the U.S. Constitution by restricting speech in two ways: by limiting the transmission of factual and accurate information about prescribing practices; and also by limiting marketing that utilizes that information said Cathy Betz, vice president, Government Affairs, Wolters Kluwer.

“Moreover, these types of laws do nothing to improve healthcare, reduce costs or protect physician/patient privacy as proponents have claimed,” Betz noted. “Today’s ruling is a very important decision for commercial speech in general. The Court invalidated most any attempt to put limits on commercial free speech in advertising and marketing.”

Christopher A. Mohr, an attorney with Meyer, Klipper & Mohr PLLC, and counsel of record for the amicus brief filed in support of IMS by the Coalition, American Business Media, The Consumer Data Industry Association, CoreLogic, The National Association of Professional Background Screeners, and Reed Elsevier Inc. offered the following comment on the Supreme Court’s opinion.

“Today, the Court re-affirmed several basic First Amendment principles and their application to the database industry. First, it rejected any suggestion that the aggregation of information into a database renders it a commodity or ‘beef jerky.’  Databases (and the publication of the information within them) are unequivocally protected by the First Amendment,” Mohr said.

“Second, the case makes clear that the government cannot prevent the dissemination of accurate information (as it tried to in this case) by discriminating against particular speakers speaking on particular subjects.  This case involved pharmaceutical information, but its implications reached far broader than that. The opinion not only protects the rights of information publishers to make information available on a variety of subjects without government interference, but also ensures that the public may receive relevant information to make better business, economic and political decisions,” he said.

The Coalition will continue to offer ongoing analysis of this decision.