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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

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July 1, 2014 – The FDA’s recently issued draft guidance on medical device data systems (MDDS) not only lessens the ...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June 23, 2014 – Although the two social media draft guidance documents the FDA’s Office of Prescription Drug Promotion (OPDP) ...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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DAA’s Self-regulatory Ad Program to Protect Consumers Online Is Praised by White House, DOC and FTC

 Feb. 23, 2012 – At a White House meeting held today to unveil the blueprint for the Obama Administration’s “Consumer Privacy Bill of Rights,” the Digital Advertising Alliance (DAA) and its members were praised by White House, Department of Commerce and Federal Trade Commission officials for their efforts during the past three years to protect consumers’ privacy online. These efforts include the DAA’s Self-regulatory Program for Online Behavioral Advertising and last month’s “Your Ad Choices” public education advertising campaign. 

“While generic viagra mexico privacy remains one of the most challenging issues in the Internet age, the Coalition for Healthcare Communication, through its work with the American Association of Advertising Agencies, is proud to be part of the solution announced by the White House today to enable consumers to better exercise their privacy and marketing preferences,” said Coalition Executive Director John Kamp. “Much still remains to be done, including urging all Web publishers, agencies and clients to take full advantage of the DAA’s self-regulatory program

in order to create a more robust and trustworthy Internet marketplace,” he added.

The DAA also announced today that it will immediately begin work to recognize browser-based choices with a set of tools by which consumers can express their preferences under the DAA principles.

“The Administration, Congress, and the FTC have been pushing the business community for several years to make sure consumers are aware of the information practices occuring online and providing choices to consumers regarding the collection and use of information about them,” said DAA General Counsel Stu Ingis. “The DAA is an embodiment of leading companies responding to this call.”

For more information on this groundbreaking news, see the press release from the 4A”s, released at noon today: http://www.aaaa.org/news/press/Pages/022312_daa_whitehouse.aspx

Do Not Track: Coming Soon to a Mobile Device Near You?

May 27, 2011 — As Congress considers six pieces of pending legislation introduced to protect consumers’ privacy online – all but one of which recommends mandatory “Do Not Track” provisions – the Senate Committee on Commerce, Science & Transportation last week held a hearing to discuss whether Do

Today saw a good website

Not Track also should be expanded to mobile device marketing.

“I think anyone who uses a mobile device has an expectation of privacy, and sadly that expectation is not always being met,” Committee Chairman Sen. John D. “Jay” Rockefeller IV (D-W. Va.) said in a statement. “As smart phones become more powerful, more personal information is being concentrated in one place. These devices are not really phones—they are miniature computers.”

Testifying before the Committee, David C. Vladeck, director of the Federal Trade Commission’s Bureau of Consumer Protection, said that mobile device applications and ads that allow for the collection of consumer information “need to provide meaningful disclosure in a small screen environment” to prevent the invisible collection and sharing of consumer data with multiple partners.

Vladeck commended Rockefeller and fellow committee member Sen. John Kerry (D-Mass.) for the two consumer privacy bills they have introduced. “Although the [FTC] has not taken a position on whether to recommend legislation in this area, the Commission strongly supports the goals of Sen. Rockefeller’s Do Not Track legislation and supports the approach laid out in that bill,” Vladeck said. Kerry’s bill does not call for a Do Not Track mechanism.

Vladeck noted that “the absence of a privacy policy makes things more difficult” to enforce and that his response to using Do Not Track in the mobile device setting is positive. “It’s hard to argue in favor of a business model that depends on deceiving consumers,” he said.

He added that the Commission “is committed to protecting consumers in the mobile sphere through law enforcement and by working with industry and consumer groups to develop workable solutions that protect consumers while allowing innovation.”

Acknowledging that industry is trying to self-regulate online behavioral advertising both online and in mobile device marketing, Vladeck indicated that the adoption of self-regulation has been rather slow. “Until advertisers agree to be bound by [self-regulation] – actually signing up and making this happen – I think the business community knows that at some point, sooner or later, there will be a Do Not Track requirement,” he told the Senate Committee.

“Whether we are conducting marketing activities online or through mobile device apps, industry must get its act together and begin self-regulation – quickly and in large numbers – if we are going to mandatory Do Not Track regulation,” said Coalition for Healthcare Communication Executive Director John Kamp. “We can’t ‘wait and see’ any longer – the time to get on board is now.”

The Coalition opposes mandatory Do Not Track provisions and believes that consumer privacy and robust Internet commerce is better served by self-regulation (www.AboutAds.com) that enables easy consumer opt-outs of unwanted tracking and marketing.prescription of levitra

Required Course for Medical Agencies: 4A’s Webinar on Your Role in Implementing the Behavioral Advertising Self-Regulation Program

May 17, 2011 — Widespread industry participation in online behavioral advertising (OBA) self-regulation is the only way for the program to succeed and for advertisers to stave off federal regulation of behavioral marketing practices, according to Dick O’Brien, head of the 4A’s Washington office and moderator of an OBA educational Webinar for ad agencies.

“Do it now,” said John Kamp, executive director of the Coalition for Healthcare Communication. “Agencies, publishers and medical companies must get on board today to make the self-regulation program work. If this program is not widespread and visible soon, Washington will mandate a ‘do-not-track’ program that will be a disaster for us, our clients and the public.”

The 4A’s Webinar, “A Complete ‘How-To’ Guide for Ad Agencies Implementing the New Industry Online Behavioral Advertising Program,” features presentations from John Montgomery, COO, GroupM; Josh Berman, director, Trading Strategy, GroupM; and Lee Peeler, president, National Advertising Review Council, Better Business Bureau. [View the free Webinar and learn more about OBA self-regulation at: http://www.aaaa.org/events/webinars/media/Pages/051011_dc_behavioral.aspx]

The Webinar speakers explain

the genesis of the AboutAds.com program and why it is so important for agencies and clients to participate now. They also cover the core principles of the program, who is covered, program icon implementation, entities’ roles and responsibilities, approved providers to assist companies, and program costs.

“The core of this sound, robust program is transparency and choice,” O’Brien said. “To keep government legislation away,” more entities must sign on for program implementation, he asserted.cialis capsules vs softabs

Two More “Do Not Track” Bills Enter the Fray

May 13, 2011 – In the span of one week, two new bills calling for “Do Not Track” provisions were introduced in Congress, increasing the pressure on lawmakers to address the various versions of Do Not Track legislation that have been introduced during the past few months.

On May 9, Sen. John D. “Jay” Rockefeller IV (D-W. Va.), Chairman

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of the Senate Committee on Commerce, Science, and Transportation, introduced the “Do-Not-Track Online Act of 2011,” a bill that is designed to empower consumers to opt out of having their activities tracked online. This bill calls for a mandatory browser-based Do Not Track mechanism and would set time limits regarding how long a company could keep any data that is collected online.

“Recent reports of privacy invasions have made it imperative that we do more to put consumers in the driver’s seat when it comes to their personal information,” Rockefeller said in introducing the bill. “I believe consumers have a right to decide whether their information can be collected and used online. This bill offers a simple, straightforward way for people to stop companies from tracking their movements online.” 

House Co-chairmen of the Bi-Partisan Congressional Privacy Caucus Rep. Edward J. Markey (D-Mass.) and Rep. Joe Barton (R-Texas) also introduced a bill on May 6 that amends the Children’s Online Privacy Act of 1998 to “extend, enhance and update the provisions relating to the collection, use and disclosure of children’s personal information and establishes new protections for personal information of children and teens,” according to a press release.

The “Do Not Track Kids Act of 2011” aims to protect children on the Internet, which is “their new 21st century playground,” Markey said. It calls for parental consent of the collection of children’s information and would establish a “digital marketing bill of right for teens.”

These two bills join four other privacy bills introduced previously by Sen. John Kerry (D-Mass.)/Sen. John McCain (R-Ariz.), Rep. Cliff Stearns (R-Fla.), Rep. Jackie Speier (D-Calif.), and Rep. Bobby L. Rush (D-Ill.). Of these bills, the Kerry/McCain bill is the only privacy legislation that does not call for a Do Not Track mechanism.

The Coalition for Healthcare Communication opposes mandatory Do Not Track provisions and believes that consumer privacy and robust Internet commerce is better served by self-regulation that enables easy consumer opt-outs of unwanted tracking and marketing. As such, the Kerry/McCain bill is the most palatable to industry “because it recognizes the value of self-regulation,” said John Kamp, the Coalition’s executive director. “We want to be able to move forward to protect consumers in a more collaborative way,” he added.viagra for cheap

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