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DTC Study Does Not Claim DTC Ads Cause Doctors to Prescribe Inappropriately

May 23, 2013 – A study of the effect of direct-to-consumer advertising for statin drugs on physician prescribing that recently was ... read more

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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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