Subscribe   RSS Contact Us

Pitts Calls Higher Drug Approval Rate a Sign of Regulatory Progress

Aug. 24, 2015 – Although some may call the FDA to task for approving more new drugs than they have ... read more

CHC and CCC Launching Regulatory Compliance University for Agencies, Publishers

Aug. 19, 2015 – The Coalition for Healthcare Communication (CHC) is partnering with the Center for Communication Compliance (CCC) to ... read more

Kamp on Presidential Politics: They Matter to Medical Marketers

Aug. 17, 2015 – In an Aug. 11 column posted on the PharmaLive website, Coalition for Healthcare Communication Executive Director ... read more

Amarin Federal Court Decision: FDA Off-Label Marketing Rules Violate the First Amendment By John Kamp

Aug. 10, 2015 – Late last week the U.S. District Court for the Southern District of New York granted Amarin ... read more

FDA Will Study How Market Claims, Efficacy Info Affect Consumers in DTC Drug Print Ads

July 29, 2015 – The FDA’s Office of Prescription Drug Promotion (OPDP) recently announced that it plans to conduct a ... read more

Congressional Briefing: Medical Information Communication Is Important Patient Issue

July 28, 2015 – Physicians and their patients need access to truthful and non-misleading data about available treatments, including off-label ... read more

CME Update: CMS Revises Guidance and Industry Ups Spending

July 20, 2015 – Two recent developments in the continuing medical education (CME) arena – a revision to CME guidance ... read more

Kamp: 21st Century Cures Act and Amarin Case Developments Are Signs of Progress

July 13, 2015 –Two events last week – the House approval of the 21st Century Cures legislation and arguments in ... read more

House Approves 21st Century Cures Act, Bill Now Heads to the Senate

July 10, 2015 — The House of Representatives today passed H.R. 6, also known as the 21st Century Cures Act, ... read more

21st Century Cures Legislation Garners House Majority Support

July 1, 2015 – The 21st Century Cures Act, which was unanimously approved by the House Energy and Commerce Committee ... read more

Google SEM Changes Affect Drug Black Box Reminder-like, Redirecting Ads

June 29, 2015 – Two changes to search engine marketing (SEM) recently announced by Google could soon alter how pharmaceutical ... read more

Physicians Say CHC-backed H.R. 293 Would Remedy “Burdensome” Sunshine Act Reporting

June 15, 2015 – More than 100 physician organizations have written to Rep. Michael Burgess (R-TX) to express their strong ... read more

Author of “Pharmaphobia” Says Conflict-of-interest Regulations Are Slowing Medical Progress

June 8, 2015 – In his new book, “Pharmaphobia: How the Conflict of Interest Myth Undermines American Medical Innovation,” Tom ... read more

Revised Guidance on Use of Brief Summary in Print DTC Ads: Full PI Is Not Needed or “Recommended”

Feb. 9, 2015 – In a revised draft guidance document released Feb. 6, the FDA is updating a 2004 version ... read more

Previous Next

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.”