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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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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 marketing costs are certain to arise as the Congress and White House struggle to reduce the deficit,  stimulate the economy and prepare for the upcoming elections. Meanwhile, the IMS Supreme Court decision is causing a stir in industry and in the courts.

Here are four things you need to know:

1. The IMS Supreme Court decision already is shaking up pending court cases involving FDA and HHS-IG enforcement of medical marketing regulations. As you know, the IMS decision undermines FDA’s ability to ban truthful information by drug companies on off-label uses of drugs. Industry and First Amendment lawyers are closely watching the federal Second Circuit Court of Appeals, a court immediately under the Supreme Court. The IMS case has become central to the appeal of Alfred Caronia, a drug representative  being charged by the United States with the crime of including off-label information in sales presentations. In a decision expected soon, the appellate court could agree with Caronia’s lawyers that uttering truthful off-label information cannot be made a crime. Several parties filed special comments based on the IMS decision (see Caronia Amicus Brief). One of the most important of these came from the Medical Information Working Group (MIWG), a coalition of seven medical product manufacturers who recently filed the attached Citizen Petition with FDA asking for clearer off-label regulations. Together, the Supreme Court decision, the MIWG Citizen Petition, and the upcoming U.S. v. Caronia decision could lead to dramatic changes in medical marketing regulation and enforcement. I will be moderating a panel on these developments at the Sept. 23 FDLI meeting (see FDLI Marketing Conference Agenda). The panel includes Harvey Ashman, General Counsel of IMS, Diane Bieri, General Counsel of PhRMA, and Bert Rein of the Wiley Rein law firm, who served as lead counsel in the Washington Legal Foundation case.

2. The deficit super committee is gearing up and quickly must come up with significant budget cuts or tax increases. While industry fared relatively well in last year’s Affordable Care Act, new money must be found and no income source will be overlooked. Indeed, the Advertising Coalition members were not surprised recently when a group targeted the medicines industry even before the committee’s first meeting. The recommendation came from the Pharmaceutical Care Management Association (PCMA), representing PBMs. PCMA sent the attached letter directly to the leaders of the deficit super committee with several suggestions for saving money by suppressing the use of branded drugs, including elimination of the tax deduction for DTC advertising. The Ad Coalition is working with industry groups, including PhRMA and media associations, to address this and other possible proposals.

3. Congressional action on health care marketing issues most likely will arise as part of PDUFA V, the appropriations bill that must pass by October 2012 to enable funding of the FDA. The FDA draft of that legislation has been in the works for more than a year and is about to be sent to Congress. The current draft includes several modifications

to FDA approval processes, including new fees for devices and generics, but no proposals for additional marketing rules. Knowing this, a coalition of consumer groups made a last-minute plea to HHS Secretary Kathleen Sebelius to include more marketing restrictions. We don’t expect HHS to agree, but know that the consumer groups will press for these changes on Capitol Hill this year and next. You will be hearing much more about PDUFA V before the bill becomes law.

4. As we wait for Sunshine provisions of the Affordable Care Act to be announced by HHS this month (http://www.cohealthcom.org/2011/03/28/coalition-stakeholders-weigh-in-during-cms-“sunshine-act”-call/), we not only are seeing the media future in the age of transparency but are getting much better prepared to handle the media spotlight. Last week, ProPublica and local media outlets filed their second wave of stories publishing data on individual doctors who have received payments for working with us and our medical clients. Although many local news outlets picked up the ProPublica material, reporters often contacted the industry and doctor groups, which worked aggressively to provide background and additional context to the stories. The industry owes special thanks for this to both PhRMA and the Association of Clinical Researchers and Educators (ACRE) (http://www.cohealthcom.org/2011/09/08/propublica-reporters-urged-to-provide-context-and-meaning-to-payment-disclosures/).

And, as always, stay tuned.

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