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The Elections Are Over: What Does It Mean for Healthcare?

Oct. 28, 2014 — Join us for a Webinar on Nov. 12! John Kamp, Executive Director of the Coalition for ... read more

FDA Response to MIWG Shows Willingness to Revisit Off-label Speech Policies

Oct. 27, 2014 – As members of Congress prepare legislation that may establish the conditions under which companies can share ... read more

House Legislation to Tackle Thorny Off-label Issues

Oct. 20, 2014 – It is looking like Congress may attempt to settle whether companies can speak truthfully about their ... read more

Bipartisan Bill Seeks Fix to Formalize Textbook/Reprint Sunshine Act Exclusions

Oct. 14, 2014 – After multiple efforts failed to convince the Centers for Medicare & Medicaid Services (CMS) that peer-reviewed ... read more

PhRMA, BIO, AdvaMed Tell FDA Social Media Guidance Is Lacking, Violates First Amendment

Oct. 6, 2104 – Although the FDA’s Office of Prescription Drug Promotion (OPDP) recently reopened the comment period for its ... read more

Social Media Master Class Helps Companies Navigate Compliance

Sept. 30, 2014 – Companies striving to use social media marketing both effectively and appropriately likely will benefit from a ... read more

Coalition Panel: Data Regulation Focus Shifting from Privacy to Security

Sept. 29, 2014 – The federal government’s efforts to severely limit the ability of industry to gather and use online ... read more

In Amicus Brief, PhRMA Says Off-label Case “Raises Serious First Amendment Concerns”

Sept. 19, 2014 – Stating that a whistleblower’s interpretation of the False Claims Act has “a critical flaw” because it ... read more

Pfizer’s Susman to Talk Public/Private Partnerships at Nov. 10 Coalition Briefing

Sept. 19, 2014 – Sally Susman, EVP, Corporate Affairs, Pfizer, will share her insights on the importance of public and ... 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

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

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

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

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

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

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

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 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

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

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UPDATE: Supreme Court finds Rx data use ban violates the First Amendment

June 23, 2011 — Justices find Vermont violated First Amendment rights of  pharma and data publishers

Sweeping aside justifications by the state of Vermont and privacy advocates, the United States Supreme Court today found the Vermont ban on marketing use of Rx data a violation of the First Amendment.

” This is a victory for patients as well as industry, ” said John Kamp, Executive Director of the Coalition for Healthcare Communication.  “Although couched in language of privacy and cost reduction, the Vermont bill was a transparent attempt to censor industry while allowing others to talk.  Enlightened public policy makers have always known that was a bad idea. Now they know it is also unconstitutional.”

More soon.

………………………

April 20, 2011 — On Tuesday, April 26, the U.S. Supreme Court hears oral arguments in a case – Sorrell v. IMS Health Inc. – that could be a game changer for data gathering companies, the pharmaceutical and biotechnology industries, advertising agencies, medical publishers and other media. The Supreme Court will decide whether the First Amendment protects the collection and marketing use of physician prescribing practices.

“Victory or loss in this case will depend largely on how the majority of Justices construe the question,” said John Kamp, executive director of the Coalition for Healthcare Communication, which filed one of 16 amicus curiae briefs in support of IMS Health. “Listen carefully to the questions by the Justices. The tenor and direction of the Justices’ questions during oral arguments will give clues to the decision, which is expected in June.”

In Kamp’s view, medical marketers have a First Amendment right to use legally collected data and data analytics to communicate with the appropriate doctors and patients using targeted messages and media. If IMS loses because the Court considers these activities unworthy of First Amendment protections, “the assaults on data gathering and use in marketing will proliferate,” Kamp commented. “The ensuing legal actions will not just be about IMS data, but all marketing uses of data, which would be a huge blow.”

Focus of Court’s Questions?

“If the Justices ask whether the Vermont ban restricts the First Amendment right of pharma companies to speak about their products, I think we’ll win,” Kamp said. “The restriction is egregious because it allows the government and managed care companies to detail using the data, but bans industry from using the same data in a similar manner,” he noted.

For example, Wolters Kluwer Pharma Solutions and similar analytical companies, as well as pharmaceutical companies, need this information in order to identify and reach the prescribers who will value information about new therapies, according to Cathy Betz, vice president, Government Affairs, Wolters Kluwer.

“What the case is not about is privacy,” said Betz. “The data that is being restricted (physician prescribing information) is stripped of patient identity and patient identifiers (as required by federal law) before we ever receive it from our suppliers. We also utilize security protections by implementing appropriate administrative, technical and physical safeguards to further protect this anonymous information,” she noted.

“Every court to consider the question has therefore recognized that patient privacy is not at issue in these cases. This law also does nothing to establish a physician privacy right in their professional practice information because it allows wide dissemination of prescriber history information to many people for many purposes,” Betz said.

However, if the Justices “decide that the question is whether or not IMS can gather and sell prescription data that in turn can be sold to pharma for marketing purposes, we may lose,” Kamp stated. “The Court has never found data gathering and use, per se, as a First Amendment-protected activity. Our brief and others argue that this activity should be protected because it informs marketing, but this could be a stretch for the Justices.”

Of course, handicapping results based on oral arguments is a very risky proposition, according to Christopher A. Mohr, an attorney with Meyer, Klipper & Mohr PLLC, and counsel of record for the amicus brief filed by the Coalition, American Business Media, The Consumer Data Industry Association, CoreLogic, The National Association of Professional Background Screeners, and Reed Elsevier Inc.

In the brief, these entities urge the Supreme Court to adopt a Court of Appeals for the Second Circuit decision that invalidated the Vermont law on the ground that it violated the First Amendment by banning the voluntary exchange of truthful information on a matter of public importance. The Coalition and its co-filers argue selective bans on data use is “wrong and constitutes a dangerous threat to First Amendment values,” and that the “compilation, aggregation and distribution of the content of informational databases is entitled to First Amendment protection.”

“If the First Amendment means anything, it means that government regulation of speech is a last resort and the government may do so in a way that is tailored to the interests it is trying to advance,” Mohr said, adding that in a related case involving the same plaintiffs (which technically is not before the Court), the Court of Appeals for the First Circuit “rejected that basic constitutional maxim and held that when information is gathered for commercial purposes and treated like a commodity, the state may regulate it just like ‘beef jerky.’

“The state and its amici are urging the [Supreme] Court to adopt the First Circuit’s view,” Mohr continued. “Such a holding is unprecedented and radical.”

Court Decision’s Implications

Henry Horbaczewski, general counsel, Reed Elsevier, agreed with Mohr’s assessment. “From my perspective, this case is about whether government can regulate information like beef jerky rather than as speech, and, in particular, whether government can regulate conduct by denying persons access to information needed to make informed decisions,” Horbaczewski said.

Mohr also asserted that there is another troubling aspect to this case. “Facts are the building blocks of discourse. In this case, Vermont has decided that those facts enable face-to-face sales presentations between drug sales reps and doctors that are truthful, but ‘too good,’” he said. “Rather than ban unethical practices (e.g., kickbacks, etc.) the state has attempted to cut off the flow of information to an industry to ‘dumb down’ these conversations … Vermont has legitimate, even compelling interests in reducing health care costs, but it has chosen a very dangerous, almost sinister means to accomplish its ends,” he concluded.

“If Vermont prevails, this decision could have implications for the free flow of information in our society, threatening numerous industries and companies that collect, analyze, and sell truthful information vital to the public,” according to Betz. “The very real fear among other companies and industries engaged in this type of business is that government can choose to restrict information flow whenever it decides it doesn’t like the outcomes in the marketplace that are being produced with the help of the information and insight,” she asserted.

The Coalition will continue to monitor ongoing developments in this case.cialis online prescriptions

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