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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

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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

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FDA Device Document Revises Mobile Medical Apps Guidance

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

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

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As Sunshine Act Phase One Implemenation Ends, Compliance Concerns Grow

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House Committee Seeks Patient Input on Availability of Treatments

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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

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OPDP Enforcement Letters Address Omission of Risk Information

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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

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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

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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

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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

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

Feb. 2, 2012 – More than four generic viagra professional hours of testimony before the House Energy and Commerce Committee’s Subcommittee on Health — and members’ follow-up – nearly exhausted the issues related to the Prescription Drug User Fee Act V (PDUFA V) legislation yesterday, but just one question focused on drug marketing.

“It has taken hard work so far to keep direct-to-consumer [DTC] and other marketing on the back burner in PDUFA V,” said John Kamp, Executive Director of the Coalition for Healthcare Communication. “But I’m still worried. Consumer and other groups pressed FDA at several points last year in the FDA phase. I don’t think they are going to give up now, so we’re watching carefully and remain prepared for a challenge.”

During the Feb. 1 hearing, medical marketing was raised just briefly. “Do you actually have any resources for DTC advertising monitoring to ensure that consumers do have a balanced understanding of the drugs and the risks advertised to them and the accuracy of those?” Rep. Jan Schakowsky (D-Ill.) asked Commissioner of Food and Drugs Margaret Hamburg, M.D. “Where are we with monitoring these DTC drug ads?” she queried.

“We do have a

group that is charged with working on the oversight of DTC advertising and there is a process that involves the screening of the DTC advertisements,” Hamburg said, adding that “we don’t have fees associated with that.” Hamburg explained that although advertising was considered in previous PDUFA negotiations, “it is not part of PDUFA V.”  

Hamburg said she gathered “that in the last PDUFA negotiation this had been identified as a possible area of focus, but actually including it was moved away from for a number of reasons that I think may have included the willingness to … include budget authority.”

“Hamburg’s response is right and appropriate,” Kamp said. “May it be the last word. However, we’re not betting the farm,” he added.

Indeed, although the exchange between Schakowsky and Hamburg was the only mention of drug advertising during this comprehensive hearing, it is unlikely to be the last, especially considering Schakowsky’s ending remark: “Given the prevalence of those ads on television, I would think that should be a major focus and I hope we can work together to make that happen,” she concluded.

Recent efforts by other entities to push for drug marketing restrictions or greater regulation of DTC ads as a part of PDUFA V are worth noting. An Aug. 31, 2011, letter from the Pharmaceutical Care Management Association (PCMA) to the Joint Select Committee on Deficit Reduction called suppressing the use of branded drugs and eliminating the tax deduction for DTC advertising “debt-reducing solutions” that it claims, combined with other prescription drug measures, could save the federal government $100 billion over 10 years.

In highlighting the PCMA recommendation to ban the DTC advertising tax deduction, the letter states that “while the First Amendment allows for such advertising, it does not require tax payers to subsidize promoting the most expensive drug treatments.”

Further, a last-minute plea from a coalition of consumer groups to Department of Health & Human Services Secretary Kathleen Sebelius asked that more marketing rules – including expanded capacity for monitoring of DTC advertising – be added to PDUFA V language.

In tandem, these proposals forward the view that further discussion of marketing in the context of PDUFA reauthorization legislation is likely to rear its head again.

“Once groups like PCMA and Consumers Union take a position, they seldom give up easily,” said Kamp. “It would be naïve to think that our fight is over.”