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July 1, 2014 – The FDA’s recently issued draft guidance on medical device data systems (MDDS) not only lessens the ...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June 23, 2014 – Although the two social media draft guidance documents the FDA’s Office of Prescription Drug Promotion (OPDP) ...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

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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

Guest Commentary: Academic Detailers or "Retailers"

May 25, 2011 –  by Peter Pitts

“Harvard Academic To Organize Insurance Industry CER Detailing Program,” gushes the headline of the article on academic detailing:

“A prominent academic at the forefront of comparative effectiveness research pharmaceutical detailing efforts will soon begin seeking support for the establishment of a third-party payer non-profit organization to help physicians receive information on medical therapies from a wider group of experts — including insurance companies — as opposed to predominantly from drug manufacturers.”

The “prominent academic?” Why it’s none other than Harvard Medical School researcher Jerry Avorn – the same high-minded and unbiased man of science who said, “Marketing departments of many drug companies don’t respect any boundaries of professionalism or the law.”

Untrue and unfair. That’s a pretty broad brush – but Dr. Avorn has never worried about the unintended consequences of hyperbole.

(Avorn already established two non-profit groups supported by government funding that help disseminate CER information to doctors. The National Resource Center for Academic Detailing obtains funding from HHS” Agency for Healthcare Research and Quality to help train academic detailers, while the Independent Drug Information Service compiles CER information and is supported by some state government agencies, including the Pennsylvania Department of Aging.)

“I”ll be, basically, phoning contacts that I know in the private sector and asking if they would like to engage in this bold adventure together,” he told FDA Week.

Well, “bold” may be one word for it.  Another, less flattering adjectival phrase — “intellectually dishonest” – may be more applicable.

(This is the same Jerry Avorn who tried to claim that there was a higher incidence of black box warnings around drugs approved right before user fee deadlines but got caught when Bob Temple and FDA economists found significant, uh, omissions in his database and “rounding” errors that, when accounted for, essentially eliminated any difference in the number of black box warnings.) 

There is little information on why so few AD programs attempt to measure overall healthcare cost reductions.  This is likely due to the fact that measuring changes in prescription drug costs is a more manageable analysis than determining changes in overall healthcare spending. It also (in the calling a spade a spade department) fits into the general cognitive mapping of those who believe that pharmaceutical costs are the main driver of health care costs. (FYI – on-patent drug costs represent less than a dime on the American healthcare dollar.)

I’ve said it before, but it’s worth repeating — the worst part about rushing headlong into academic detailing is that there is no clear articulation or transparency regarding the specific rules and regulations that will govern the behavior and activities of AHRQ-funded detailers.

Some of those unanswered (and, alas, unasked) questions:

Q: What safeguards are in place to certify that physicians are being presented information that is unbiased? Previous government detailing efforts have often focused on demonstrating their own value by highlighting the cost effectiveness of initiatives through savings generated from the increased utilization of generics and other low-cost therapies.

Asked another way – how can an “academic detailing” program funded by our nation’s largest payer be considered neutral? Just like detailing programs run by pharmaceutical companies, there is an inherent “interest.” And that’s okay – as long as that “interest” is transparent.  But “academic” it ain’t.

Q: What information is worthy of being detailed by these programs?  Who decides and on what basis?What can they say or not say?  Who decides? Will they have to play by the same rules as pharmaceutical representatives?  And, importantly, what is the oversight mechanism?  If academic detailers stray into off-label conversations, to whom does DDMAC send a letter?  Who does the Department of Justice investigate? Who pays the fine?

All this to say that, if academic detailing is the

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answer – what’s the question?

As the old Crazy Eddie commercial asked, “What’s the story, Jerry?”flagyl 400

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

More Social Media Studies Planned at FDA

Immediate Guidance Slips Again 

May 9, 2011 – A recent notice in the Federal Register calling for comments on a series of Food and Drug Administration (FDA) studies to determine the most effective way of presenting risk information online indicates that the FDA is still a long way from developing significant new social media guidance. This status leaves industry in an unsurprising state of limbo after the Division of Drug Marketing, Advertising, and Communications (DDMAC) missed at least two self-imposed deadlines for issuing draft guidance and did not set a new target date for the much-anticipated document.   

“The FDA’s choice to start new studies rather than issue guidance is unfortunate,” said John Kamp, executive director of the Coalition for Healthcare Communication. “Healthcare providers, patients and care givers are on the Internet, searching and finding health information. Companies, knowing that much Internet health information is uninformed and biased, must participate even without FDA guidance,” Kamp asserted.   

The agency states in an April 28 Federal Register notice that it plans to research the new venues available online for displaying risk and benefit information for prescription drug ads in a fair and balanced way. 

 According to the FDA, “The interactive nature of the Internet allows for features not possible with traditional media … such as scrolling information, pop up windows, linking to more information, and embedded videos.” The agency is planning a series of studies that test the different methods of risk and benefit information on branded drug sites, the results of which will “inform the development of future guidance.” 

Study 1 will examine the visibility of risk information (scrolling versus no scrolling), Study 2 will look at whether special features (e.g., testimonial videos, interactive videos) influence the perception of risks and benefits, and Study 3 will investigate whether links to and citations from external organizations referenced on the home page affect consumer perception and understanding of risks and benefits. 

“It was anticipated that the FDA’s draft Internet guidance … would address the key question about the possible use of hyperlinks to provide risk information in a variety of online and social media formats,” according to Arnold I. Friede, Arnold I Friede & Associates. “In its 14 [notices of violation] on the use of hyperlinks in sponsored research results, FDA categorically rejected the possibility that providing information via such links could possibly constitute ‘fair balance.’” 

Friede also commented that the FDA’s “categorical rejection” of the use of hyperlinks to provide risk information is “inconsistent with the approach FDA has taken in other analogous contexts.” 

Without any guidance in “the near term,” Friede continued, industry has two choices: (1) “refrain from engaging in any behavior that is the subject of the proposed studies,” or (2) “make rational decisions about what is and is not justified, or at least what should be justified, from a legal, policy, and communications standpoint.” 

If a company takes the latter approach, it should be “prepared to defend those decisions if questioned by the FDA,” Friede

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asserted, adding that “many decisions in business are made in the absence of perfect knowledge.”

The Coalition’s Kamp consistently has stated that agencies and clients should continue their marketing efforts online while following existing FDA policy, especially in light of DDMAC officials’ statements that the FDA will not break new ground with its social media guidance.

“Wrong or right, the FDA has been up front in stating that it has no intention of creating a new Internet and social media policy at this time,” Kamp said. “FDA’s plan to conduct research in this area is just one more indication of that position.”viagra original use

Kamp to Chair Social Media/Patient Care Panel at DIA Annual Meeting

May 5, 2011 — The regulatory challenges and marketing opportunities facing drug, device and biological companies using digital and social media to reach doctors, patients and caregivers will be discussed by experts with both marketing and regulatory backgrounds at the Drug Information Association’s 47th Annual Meeting, held June 19-23 in Chicago.

A June 22 panel session, “The Problems and Promise of Using Social Media to Improve Patient Care,” which is being chaired by Coalition for Healthcare Communication Executive Director John Kamp, will outline the regulatory environment in which companies are using social media to promote their products and will review concerns regarding the public relations and legal risks posed by the public, the plaintiff’s bar, and state and federal law enforcement agencies.

Forum panelists include special speaker Christopher M. Schroeder, CEO and board member, HealthCentral, as well as Mike Myers, president, Palio; Sharon Callahan, CEO, The Vue Group & LLNS; and Stuart Ingis, partner, Venable LLP. For more information on the conference, go to http://www.diahome.org.uk viagra purchase

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