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WLF to CMS: Deem Medical Textbooks Educational Materials or Face Potential First Amendment Challenge

May 16, 2013 – The Centers for Medicare & Medicaid Services (CMS) is likely “to find itself the target of ... read more

Kamp in MMM: Off-label Is on the Table

May 14, 2013 — In a Medical Marketing and Media (MMM) column posted May 1, Coalition for Healthcare Communication Executive ... read more

Next OPDP Webinar Will Address Five Months of Enforcement Actions

May 14, 2013 — The FDA’s Office of Prescription Drug Promotion (OPDP) will be holding an Enforcement Webinar May 16, ... read more

Many Physicians Are Both Unaware and Wary of Sunshine Act Requirements, Survey Says

May 6, 2013 — With Sunshine Act reporting slated to begin in less than three months, it is sobering to ... read more

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 – ... read more

Coalition: Educational Materials Should Be Excluded from Sunshine Reporting

April 22, 2013 – In April 18 comments to the Centers for Medicare & Medicaid Services (CMS) the Coalition for ... read more

White Paper Examines FDA Enforcement in Digital, Social Media Realm

April 4, 2013 – A new White Paper, “FDA Communications Oversight in a Digital Era,” issued April 2 by Eye ... read more

Policy and Medicine: News Outlets Accentuate the Negative in Describing Industry-Physician Relationships

April 4, 2013 — Headlines run by news outlets regarding the status of industry-physician relationships rarely focus on the benefits ... read more

Kamp Commentary: Supreme Court Decision Could End “Pay for Delay,” Hurt Patent Protection

April 1, 2013 – By John Kamp, Executive Director, Coalition for Healthcare Communication While not directly about communication and marketing, ... read more

Promotion Down, But Prospects Up for New Drugs

March 22, 2013 – Although spending on drug promotion has declined in recent years,  2013 could be a pivotal year ... read more

“Cyberspace Is Not Without Boundaries,” FTC States in Digital Advertising Guidelines

March 19, 2013 – Although the FDA has not yet issued its long-awaited social media guidance for the biopharma industry, ... read more

NDHI Releases Statement Outlining Four Principles for Industry/Provider Collaborations

March 11, 2013 – Healthcare industry collaborations with physicians and researchers have “been at the heart of most of the ... read more

Study Cites Benefits of Pharma’s Promotional Efforts

March 4, 2013 – A recent study released by the National Bureau of Economic Research (NBER) states that although consumer-directed ... read more

CMS Launches "OpenPayments" Site as Part of Sunshine Implementation

Feb. 25, 2013 – The Centers for Medicare & Medicaid (CMS) launched its “OPENPAYMENTS” Website last week, which will be ... read more

Sunshine Act Final Rule: Coalition for Healthcare Communication Summary

On Feb. 1, the Centers for Medicare & Medicaid Services (CMS) issued a final rule implementing the Sunshine Act provisions ... read more

Sunshine Act Final Rule Resets Clock on Annual Reporting of Payments to Physicians

Many Questions Still Unresolved Feb. 4, 2013 – Although the final rule to implement the Sunshine provisions of the Affordable ... read more

Coalition’s Policy Update: Keep Fiscal Challenges, Privacy Regulation on Radar

Jan. 15, 2013 – If 2012 – with its high number of new drug approvals, senior staff stability within the ... read more

OPDP Untitled Letters on PR Materials Surprise Industry

Nov. 27, 2012 – An Oct. 31 enforcement letter from the FDA’s Office of Prescription Drug Promotion (OPDP) to Cornerstone ... read more

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 ... read more

Sorrell v. IMS: What Marketing Professionals Need to Know

By John Kamp, Executive Director, Coalition for Healthcare Communication July 18, 2011 — For those who have not read the ... read more

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Forbes Article Shines New Light on “Academic” Detailing

Oct. 29, 2012 – A recent op-ed piece in Forbes about the federal government’s sponsorship of “academic” detailing reiterates what industry proponents have been saying for some time: This government program may “gloss over the fact that less-expensive treatment options that are effective for most patients often won’t work for some of them,” and “can be harmful to patients who don’t respond to medicine in the same way as a majority of patients.”

“Bringing widespread attention to this issue, which is likely to result from this op-ed in a major publication, is vital to ensuring that there is not a double standard for the biopharma industry, whereby the industry’s hands are tied but the government gets a helping hand and patients have reduced access to drugs that can really benefit them,” said Coalition for Healthcare Communication Executive Director John Kamp.

The Oct. 24 Forbes article, authored by Henry I. Miller and Jeff Stier, states that a House Appropriations subcommittee has voted to support legislation that would eliminate funding for the Agency for Healthcare Research and Quality (AHRQ) and therefore put an end to the AHRQ’s academic detailing program. The program, which sends government representatives into the offices of healthcare providers “to offer a supposedly more disinterested viewpoint,” … “sounds good in theory, but a glaring lack of transparency in the program makes it hard to know how it functions in practice,” the article states.

Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest, has been critical of academic detailing from the start. In his view, the program, which “is not academic detailing or government detailing, but counter detailing, is ill-advised and poorly constructed.”

Pitts told the Coalition that two significant problems in the program lead to an unlevel playing field:

(1)   The government can offer free continuing medical education credits as enticements for scheduling appointments with government detailers (which cannot be offered by industry); and

(2)   Government program materials do not have to be vetted by the Food and Drug Administration (FDA), even though industry materials are subject to FDA review.

“The ACCME has stated that the federal government has

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no conflicts warranting greater transparency, even though it is the largest payer of health care technology,” Pitts said. “That’s like saying an insurance

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company has no conflicts and it’s just the wrong position.”  

In an article published earlier this year in the Drug Information Journal, Pitts stated that the government program’s supposed goal of cutting costs has not been proven, noting that “a strategy that’s good for payers” often is “bad for patient outcomes.” The program and other policies like it “are pernicious to both the public purse and the public health,” Pitts wrote. To view the full Pitts article, go to: http://media.drugwonks.com/media/attachments/501e56cc2017a8354f00001e.pdf?1344165580

Miller and Stier underscore this point: “The program is plagued by the same sort of conflict of interest as drug detailers, just in reverse. The law exempts the feds from the same transparency standards applied to the drug industry.”

The authors also cite concerns about several issues: the government failing to note that drugs may be metabolized differently by certain individuals; a lack of reporting requirements for government detailers; and a lack of transparency. The government’s agents “should have to abide by the same degree of scientific oversight and transparency standards demanded of others,” they state.

Pitts is pleased that the Forbes authors have taken up this issue. “I am glad there are now more voices in this argument,” he said.

To view the Forbes article, go to: http://www.forbes.com/sites/henrymiller/2012/10/24/a-lack-of-government-transparency-the-devil-in-the-detailing/

Pitts: Important Details on Government Detailing

June 13, 2012 – In a recent blog entry on Drugwonks.com, Center for Medicine in the Public Interest President and Co-founder Peter Pitts provides a link to his article on government detailing in a recent issue of the Drug Information Journal (http://media.drugwonks.com/media/attachments/4fd748c92017a87e7400000c.pdf?1339508937).

In the article, Pitts states that this so-called “academic” detailing

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is important to understand because “significant government funding has been provided to develop and roll out academic detailing programs.” This matters, he states, because the federal government “is spending tens of millions of tax dollars to tell American physicians how to practice medicine based on comparative effectiveness studies that are commissioned without any public input or transparency.”

To view the Drugwonks.com blog entry, go to: http://drugwonks.com/blog/government-detailing-by-number

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