Subscribe   RSS Contact Us

Mark Shields to Share Political Insight at Coalition’s D.C. Meeting Sept. 23

Sept. 15, 2014 – Political analyst Mark Shields will be the keynote speaker at the Coalition for Healthcare Communication’s Washington ... read more

CMS Bombarded with Comments Calling for CME Exemption to Remain

Sept. 9, 2014 – An overwhelming majority of comments sent to the Centers for Medicare & Medicaid Services (CMS) by ... read more

Coalition Comment to CMS: Keep CME Exemption Under Sunshine Act

Sept. 2, 2014 – The Coalition for Healthcare Communication’s comment to the Centers for Medicare & Medicaid Services (CMS) asks ... read more

Open Payments Website Reopened, Dispute Period Extended and One-third of Records Withheld

Aug. 18, 2014 – The Centers for Medicare & Medicaid Services (CMS) recently announced that it had reopened its Open ... read more

Medical Groups Ask CMS to Make Changes to Sunshine Act Implementation

Doctors Recommend Fixes to CME Exemption Elimination, Educational Materials Provision Aug. 6, 2014 – More than 100 medical associations and ... read more

Doctors and Industry: When Sharing Sunshine Data, Context Matters

July 29, 2014 – Industry groups and physician organizations have banded together to petition the Centers for Medicare & Medicaid ... read more

Doctor Tells Congress That Communication Is Hampered by FDA, CMS Practices

July 28, 2014 – FDA and Centers for Medicare & Medicaid Services (CMS) policies are barriers to ongoing evidence development ... read more

FDA Plans to Study Effect of DTC Ads on Adolescents

July 24, 2014 – A better understanding of how adolescents weigh risks and benefits in direct-to-consumer (DTC) ads is needed ... read more

Bruce Grant Urges Pharma Communicators to Recognize Their Role in Health Advances

July 23, 2014 – Although the pharmaceuticals industry has come under fire in recent years, it is important to remember ... read more

FDA Social Media Draft Guidances Answer Some Questions, Raise Others

July 21, 2014 – Although the FDA has attempted to provide some clarity on its position regarding certain social media ... read more

Kamp to Washington Post: Companies Should Be Able to Speak Truthfully About Drugs

July 14, 2014 – Drug companies should be allowed to share truthful information about the off-label uses of their drugs, ... read more

CMS Proposes Eliminating CME Sunshine Act Exemption

July 7, 2014 – About 240 pages into the 600-page physician fee schedule proposed rule, which is due to be ... read more

FDA Device Document Revises Mobile Medical Apps Guidance

July 1, 2014 – The FDA’s recently issued draft guidance on medical device data systems (MDDS) not only lessens the ... read more

New FDA Social Media Guidances Address Space-limited Media, Correcting Online Misinformation

June 23, 2014 – Although the two social media draft guidance documents the FDA’s Office of Prescription Drug Promotion (OPDP) ... read more

AMA House of Delegates: Revise Sunshine Act Rules on Textbook/Reprints and TOV Amount

June 12, 2014 – The American Medical Association’s (AMA’s) House of Delegates is attempting to bring some common sense to ... read more

As Sunshine Act Phase One Implemenation Ends, Compliance Concerns Grow

June 9, 2014 – In a recent Pharmalot blog post on The Wall Street Journal site, Ed Silverman writes that ... read more

House Committee Seeks Patient Input on Availability of Treatments

June 3, 2014 – The House Energy and Commerce Committee is seeking public comments from patients, providers and other stakeholders ... read more

FDA To Study Viewers’ Responses to DTC Ad Risk Information

May 29, 2014 – The FDA announced May 28 in the Federal Register that it plans to conduct an eye ... read more

FTC Calls for Data Broker Legislation To Protect Consumers

May 29, 2014 – The Federal Trade Commission (FTC) released a report May 27 in which it asks Congress to ... read more

OPDP Enforcement Letters Address Omission of Risk Information

May 23, 2014 – The FDA’s Office of Prescription Drug Promotion (OPDP) has issued just three Untitled Letters to date ... read more

New Yorker Article Weighs Sales Rep Free Speech Arguments in Off-label Context

May 22, 2014 – Both sides of the argument over whether sales representatives’ speech about off-label drug uses are protected ... read more

WLF: FDA’s Revised Reprint Draft Guidance Violates Injunction and First Amendment

May 19, 2014 – In May 15 comments to the FDA regarding its draft guidance on reprint practices for articles ... read more

FTC Cites Privacy Concerns Related to Mobile Health Apps

May 9, 2014 – Mobile health and fitness applications are on the Federal Trade Commission’s privacy-protection radar following a study ... read more

CHC Comment to FDA: Less Is More in DTC TV Ads

May 2, 2014 – The Coalition for Healthcare Communication believes that “shorter, simpler disclosures are most likely to lead to ... read more

FDA Willing to “Re-examine” Off-label Policies in Light of First Amendment Rulings

April 28, 2014 – The FDA is not taking lightly industry’s concerns that its existing off-label policies are not in ... read more

CHC Press Release: Comment on Social Media Draft Guidance

April 9, 2014 — The Coalition for Healthcare Communication issued the following press release today regarding the CHC Social Media ... read more

Some States Impose Reporting Requirements That Add to Sunshine Burden

April 7, 2014 – Although the Physician Payment Sunshine Act preempts state laws that require reporting of similar information required ... read more

Kamp to WSJ: FDA Could Do a Better Job of Defending Off-label Limits

March 31, 2014 – The FDA’s recent draft guidance on disseminating reprints, textbooks and clinical practice guidelines (CPGs) discussing off-label ... read more

OPDP Issues First Untitled Letter for Branded Facebook Page

March 14, 2014 – The FDA’s Office of Prescription Drug Promotion (OPDP) on Feb. 24 issued its first enforcement letter ... read more

Cuts in Speaker Payments Should Be Placed in Proper Context

March 10, 2014 – The need for industry to educate the public on why company interaction with physicians is both ... read more

FDA Issues Updated Draft Guidance on Distributing Scientific and Medical Info on Unapproved New Uses

March 3, 2014 – The FDA announced today the availability of a new draft guidance (2014-04560) on distributing scientific and ... read more

New Tax Reform Legislation Includes Limit on Ad Tax Deductions

Feb. 27, 2014 – As expected, tax reform legislation introduced yesterday by Senate Ways and Means Committee Chairman Dave Camp ... read more

FDA Is Considering Shorter List of Risks in DTC TV Ad Major Statement

Feb. 17, 2014 – In recognition that the stream of risks currently disclosed on direct-to-consumer (DTC) television ads may be ... read more

OPDP Enforcement Letters Target Common Issues in Last Half of 2013

Feb. 4, 2014 — Many of the 14 enforcement letters issued by the FDA’s Office of Prescription Drug Promotion (OPDP) ... read more

Caronia Decision One Year Later: Off-label Change May Be Slow, But It’s Brewing

Jan. 27, 2014 – Although FDA officials have treated the U.S. Court of Appeals for the Second Circuit decision in ... read more

Coalition Seeks Input on FDA Online Promotion Guidance

Jan. 23, 2014 – The Coalition for Healthcare Communication would like to receive feedback from its members regarding the FDA ... read more

FDA Draft Guidance Addresses Postmarket Submission of Online Promotional Material

Jan. 14, 2014 – The determining factor regarding whether a firm submits online prescription drug promotional material to the agency ... read more

Kamp on Off-label Discussion at the CMS/FDA Summit

Jan. 3, 2014 – From Coalition for Healthcare Communication Executive Director John Kamp: Several weeks ago I was privileged to ... read more

Coalition Calls on Senators to Reject Tax on Advertising

Dec. 16, 2013 – Today the Coalition for Healthcare Communication sent a letter to U.S. Senators and Members of the ... read more

House Members Speak Out Against Inclusion of Textbooks, Reprints in Sunshine Act Reporting

Nov. 26, 2013 – On Nov. 22, 23 members of the U.S. House of Representatives sent a letter to the ... read more

OPDP Sends Warning Letter Based on Statements Made on Fast Money TV Show

Nov. 11, 2013 – The FDA Office of Prescription Drug Promotion’s (OPDP’s) recent enforcement actions – four Untitled Letters and ... read more

Physician Organizations, Medical Societies Implore HHS to Reverse Policy on Reprints and Textbooks

Oct. 28, 2013 – On Monday, 33 physician organizations and 41 national and state medical societies sent a letter to ... read more

MIWG Asks FDA to Clarify Position Regarding Manufacturer Dissemination of New Use Information

Sept. 16, 2013 – The Medical Information Working Group (MIWG), a coalition of medical product manufacturers seeking to improve the ... read more

Previous Next

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 entire June 23 Sorrell v. IMS Health Inc. Supreme Court decision (No. 10-779), here is a quick summary of what happened and what drug marketing executives need to know.

Top line, the Supreme Court majority not only affirmed the commercial speech rights of pharmaceutical companies to buy and use prescription data for marketing, it also protected the rights of data companies to compile, analyze, publish and sell those data in the increasingly data-driven digital environment.

The Supreme Court also appears to have raised First Amendment scrutiny applied to government restrictions on virtually all truthful marketing activities. Indeed, the Court applied “heightened scrutiny” in this case, apparently expanding the traditional protections for “commercial speech” under the Central Hudson test used for the past 20 years. Moreover, the 6-3 decision logically applies to all marketing, not just medical marketing, strengthening our alliances with consumer marketers and media, including digital media.

For those not familiar with the case, IMS and others challenged a Vermont ban on the marketing use of prescriber data by drug companies. At the same time, Vermont had allowed these data to be used for “counter-detailing” by insurers, managed care and the state. The Supreme Court said Vermont illegally limited speech because it did not like the speaker nor the message and especially because the marketing was effective, i.e., presumably increasing prescription rates for branded drugs.

Vermont said the rules were designed to save money by increasing the use of generic drugs and to protect doctor privacy by protecting them from unwanted sales tactics. The Court said there were non-speech ways to save money and that the protection of doctor privacy was nominal given that others could use the data in marketing.

The Court’s decision may strengthen significantly the position of the Coalition and our industry partners in Washington as we resist legislation and rules banning or restricting marketing. Indeed, the Supreme Court decision calls into question many of the FDA’s restrictions on truthful company speech, especially truthful “off-label” statements by drug sponsors. Drug marketing remains the most prominent heavily regulated topic in advertising, but has not been routinely subject to rigorous regulator restraint or judicial scrutiny. That could change.

Supreme Court Decision Highlights:

(1) Government restrictions based on commercial content and industry speakers were subjected to “heightened” First Amendment scrutiny, much like that traditionally applied to political or so-called “pure speech.” The only clear difference apparent in this decision between “pure speech” and commercial speech that is false or misleading commercial speech is not protected by the First Amendment.

(2) Data and data analytics are also treated as speech protected by the First Amendment. This includes data companies of all types, plus publishers and users of these data.

(3) Marketing restrictions and marketing bans were treated similarly, limiting indirect as well as direct restrictions on marketing communications and making it harder for law makers and regulators to suppress or ban marketing one restriction at a time. 

(4) Government attempts to save money and to protect individual privacy remain potent reasons to regulate speech, but governments cannot just assert these as justifications. Applying traditional First Amendment rules for “pure speech” as well as commercial speech, the Court reasserted that governments must ensure that such rules are narrowly written to avoid burdening speech, and must achieve the legitimate purposes of the law. Additionally, governments must first consider and use non-speech restrictions when possible.

(5) FDA lawyers must be concerned about the continued viability of many of its marketing polices, especially restrictions on truthful “off-label” communications by drug sponsors. Although industry seldom challenges these restrictions, a group of companies recently filed a Citizen’s Petition seeking “clarity” on these rules. This could be a significant step forward. Watch this Website for more background and analysis on this Petition.

(6) Narrow restrictions based on drug safety, such as REMS requirements, were not at issue here. Although subject to First Amendment scrutiny, legitimate safety restrictions are less likely to fail.

Bottom Lines

As a result of this Supreme Court decision, clients, publishers and agencies are in a much better position today to oppose restrictions on marketing and marketing analytics when imposed by all governments, including states, the Congress, the FTC and the FDA.

This case also underlines the value of medical industry alliances with consumer marketers and media publishers, as well as with vendors and other allies. The broad language in this decision arguably applies to all marketers and supports our joint activities with a wide range of allies, including the AAAA, the Internet Advertising Bureau, the Ad Coalition, the Digital Advertising Alliance and the new Digital Health Coalition.

Moreover, the decision enables us to use the First Amendment to defend innovative and effective marketing of all types, including in the digital space where data and data analytics promise to power effective and efficient messaging. While we still must respect reasonable expectations of privacy, the decision will help us resist proposals for broad versions of “Do Not Track” and other limits on digital professional and consumer communication.

However, it is important to remember that opponents of medical marketing are undaunted, very well funded, and remain darlings of the press. These groups will be visible, litigious and smart. Although we had our day and court and won, related policy and legal challenges battles will arise soon.

 

Great product and excellent customer support! Excellent price, prompt shipping, fair shipping price, and delivery right on schedule. Generic viagra? If you get a new prescription and need it filled that day, you can walk into a pharmacy and get it taken care of.