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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

Refuting Inaccurate CER Results Is “Right” of Drug Sponsors, Temple Says

Feb. 13, 2012 – Dr. Robert Temple, the unofficial dean of drugs at the FDA, recently addressed one of the ... 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

Drug Facts Literature Review: Call for Comments

Feb. 3, 2012 – There are just 10 days left to comment on an FDA draft report that explores the ... read more

House Health Subcommittee PDUFA V Hearing Yields Little Talk of Marketing – For Now

Feb. 2, 2012 – More than four hours of testimony before the House Energy and Commerce Committee’s Subcommittee on Health ... 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

OPDP to Industry: Voluntary Compliance Efforts in New Year Can Prevent Same Old Violations

Jan. 6, 2011 – As the pharmaceutical industry begins 2012, the FDA’s Office of Prescription Drug Promotion (OPDP) recommends that ... 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FDA Issues Draft Guidance on Unsolicited Off-label Info Requests, Addresses both Professional and Internet Media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

Finally, CMS Issues Sunshine Act Proposed Rule and Resets Compliance Deadlines

Dec. 15, 2011 – The Centers for Medicare & Medicaid Services (CMS) issued its long-awaited Proposed Rule for implementing the Physician ... read more

MMM Previews Pharma Debates in DC: Prepare for a Wild Ride in 2012

Dec. 12, 2011 — Facing a need to decrease spending and boost revenues, the federal government will continue to target ... read more

Government, Industry and Educators Are Called to Action on a Looming Health Crisis

  By Jack E. Angel, Education Foundation Executive Director, Coalition for Healthcare Communication Nov. 14, 2011 — In response 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

Fall 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 ... 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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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 the legal community because it extends greater First Amendment protection for marketing and expands that protection to data mining and use. In addition, many legal scholars openly are questioning whether the FDA can continue its current regulation of “off-label” communication by drug companies as well as whether the government can continue to use privacy as a justification for marketing limits.

The following are summaries and links to recent articles on the decision written by lawyers from Arnold & Porter, Jenner & Block, and Wiley Rein, as well as an article from the National Legislative Association on Prescription Drug Prices (NLARx) that outlines the organization’s disappointment with the decision.

Does Sorrell v. IMS Health Mark the End of Off-Label Promotion Prosecution?   In an article appearing in BNA’s Pharmaceutical Law & Industry Report, Arnold & Porter partners Lisa Blatt, Jeffrey Handwerker, John Nassikas and Kirk Ogrosky discuss the impact of the Sorrell decision on “the debate over the constitutional validity of ‘off-label’ promotion prohibitions.” The authors assert in the piece that Sorrell “provides strong support for challenging FDA’s efforts to regulate what the government calls the off-label promotion of drugs for medical uses that are not approved by the FDA.” Indeed, the authors state, “Sorrell builds on prior Supreme Court precedent in establishing a strong foundation to argue that a pharmaceutical company’s truthful, non-misleading information about its products cannot be subjected to content-based and speaker-based restrictions.” Read more by clicking here.

Does the Supreme Court’s Sorrell Decision Threaten Privacy?   An article written by Wiley Rein Partner Bruce McDonald in the firm’s Privacy in Focus publication discusses the role privacy plays in the Sorrell case. Although some privacy advocates assert that the Supreme Court’s decision is a blow to privacy, McDonald states that “another reading is simply that invoking privacy arguments as justification for a statute having another purpose can prove to be an unsuccessful legislative or litigation strategy.” He also comments that the Court’s willingness to give considerable weight to First Amendment protections in a commercial context may trouble privacy advocates, but notes that “a conclusion that the majority decision is anti-privacy would appear to be overreaching,” largely because the majority “clearly doubted” that the Vermont statute in question sought to advance privacy. Read more at http://www.wileyrein.com/publications.cfm?sp=articles&id=7222

Supreme Court Observations: Sorrell v. IMS Health Inc.   An article appearing in the Washington Legal Foundation’s Legal Pulse publication, written by Paul M. Smith, chair of Jenner & Block LLP’s Appellate and Supreme Court Practice and co-chair of its Media and First Amendment Practice, analyzes the dissenting opinion in the 6-3 decision. “This dissent reflects a remarkable indifference to the core First Amendment principle that government should not use direct or indirect regulation of speech as a means of influencing people not to make perfectly lawful decisions,” Smith writes. Read more at http://wlflegalpulse.com/2011/06/24/supreme-court-observations-sorrell-v-ims-health-inc/

Will Supreme Court Decision in Sorrell v. IMS Tie States’ Hands in Medical Records Privacy Efforts?   The National Legislative Association on Prescription Drug Prices (NLARx) calls the Sorrell decision “a huge disappointment to legislators who have sought to protect the confidentiality of private prescription records.” An article on the NLARx Website, written by NLARx Executive Director Sharon Anglin Treat, states that “the expansive decision by the U.S. Supreme Court, which extends new protections to commercial speech, should be a concern to anyone interested in keeping private information private.” Read more at: http://www.reducedrugprices.org/read.asp?news=6207