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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July 1, 2014 – The FDA’s recently issued draft guidance on medical device data systems (MDDS) not only lessens the ...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June 23, 2014 – Although the two social media draft guidance documents the FDA’s Office of Prescription Drug Promotion (OPDP) ...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

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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 – which include its industry Self-regulatory Program for Online Behavioral Advertising and its “Your Ad Choices” public education campaign – the Senate Commerce Committee appears to be underwhelmed by companies’ self-regulation efforts and the DAA’s promise to honor “Do Not Track” requests from consumers.

“Consumers are still waiting for these Do Not Track standards. Advertisers are continuing to ignore Do Not Track headers and consumers’ requests for privacy,” said Sen. Jay Rockefeller (D-W. Va.), Chairman of the Senate Commerce Committee, at an April 24 hearing: “A Status Update on the Development of Voluntary Do-Not-Track Standards.”

“I have long expressed skepticism about the ability – or willingness – of companies to regulate themselves on behalf of consumers when it affects their bottom line,” Rockefeller said. “I disclose a generally troubling feeling I have about the nature of corporations around the chance to make money when people don’t know” what information is being collected about them, he continued.

DAA Self-regulatory Program Status

The DAA’s program is designed to provide choice to consumers regarding how they want their privacy protected. “The DAA’s efforts have helped to ensure that consumers will continue to have preferences regarding which ads they wish to see using a one-button mechanism,” said Coalition for Healthcare Communication Executive Director John Kamp. “But clearly, there is still more work to be done and stakeholders have to find common ground to move forward successfully.”

In February 2012, the DAA announced that it would begin work to recognize browser-based choices with a set of tools by which consumers could express their preferences under the DAA principles. Since then, two browser companies, Microsoft and Mozilla, have announced plans to install Do Not Track features that would automatically default to full protection without consumers having to make a choice.

DAA Managing Director Lou Mastria testified before the Senate committee that these features undermine the industry agreement made in February 2012, because they remove consumer choice – a linchpin in the agreement – from the equation.

In March 2012, the Federal Trade Commission (FTC) called on industry to step up self-regulatory practices or live with Congress stepping in. At the recent American Advertising Federation annual advertising day on Capitol Hill, FTC Chairwoman Edith Ramirez stated that the advertising industry should work with the World Wide Web Consortium (W3C) to develop a browser-based solution and praised Microsoft and Mozilla for their efforts, so it appears that support for voluntary programs may be wavering.

Although Harvey Anderson, Mozilla Senior Vice President of Business and Legal Affairs, told the committee that “industry has not moved forward quickly enough,” and that “the efficacy of the Ad Choice program remains questionable,” he did also state that “the work of the DAA should be acknowledged.”

Mastria told the committee that the DAA self-regulatory program protects consumers while also allowing them access to ad-supported content, adding that changes to the current paradigm would harm small publishers while also “chilling innovation.” He said that the DAA “is a solution provider” and the only entity that actually delivers choice for consumers.

“Today, the DAA calls on all stakeholders, including the FTC, W3C, Microsoft and Mozilla to honor the terms of the [February 2012] announcement and remove impediments that are preventing implementation of browser-driven choice for consumers,” Mastria said.

Is Legislation Needed?

Sen. Richard Blumenthal (D-Conn.) asked whether Congress should move forward with legislation in this area, because “when voluntary agreements fail to provide compliance, that’s the classic instance where a law is needed.” Mastria replied that “legislative or technological fiats are not necessarily what the Internet needs. A nimble, self-regulatory approach [like DAA’s] is exactly the kind of thing that fosters consumer trust while protecting privacy.”

He later added that the DAA program delivers “the very mechanisms” that are in Do Not Track legislation (DNT2013) introduced Feb. 28 by Rockefeller and Blumenthal. This legislation would:

  • Create a universal legal obligation for all online companies to honor consumer choice when consumers do not want anyone to collect information about their online activities;
  • Allow the FTC to pursue enforcement action against any company that does not honor this request by consumers;
  • Allow companies, upon consumer requests to not be tracked, to collect only the information that is necessary for the Web site or online service to function and be effective, but then place a  legal obligation on the online company to destroy or make anonymous the information after it is no longer needed.

“Industry needs to strongly advocate for – and deliver on – its promise to implement the levels of online privacy protection that the public is seeking,” Kamp said. “For the DAA’s program to thrive, consensus on how the program will work for all stakeholders is key.”