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Senate Bill Would Loop Nurse Practitioners and PAs into Sunshine Reporting

Oct. 12, 2015 – A bill introduced in the Senate last week by Sen. Charles Grassley (R-Iowa) and Sen. Richard ... read more

Which Standard of Truth Will Be Used To Evaluate Non-misleading Ad Claims?

Oct. 5, 2015 – Following numerous First Amendment court cases about promotional speech decided in favor of pharmaceutical companies, it ... read more

Prescription Drug Marketing Targeted by Hillary Clinton

Sept. 24, 2015 – Presidential hopeful Hillary Clinton just announced that she would “demand a stop to excessive profiteering and ... read more

CMPI: Value of Prescription Drugs Is Underestimated

Sept. 21, 2015 – Despite widespread reports about the soaring prices of prescription drugs and calls by the federal government ... read more

Pacira Files Complaint Calling FDA Marketing Restrictions Unconstitutional

Sept. 10, 2015 – On the heels of last month’s ruling in Amarin v. FDA, which held that the FDA ... read more

Comment Period for Brief Summary Revised Guidance Extended to Oct. 5 Under Second Revision

Sept. 8, 2015 – To incorporate animal prescription drugs into its revised draft guidance on Brief Summary and Adequate Directions ... read more

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

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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

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 ( 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:]

The Webinar speakers explain

the genesis of the 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 viagra purchase

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