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New Hampshire Amends Patient Privacy Law Following IMS v. Sorrell Decision

May 11, 2012 — In the wake of the June 2011 U.S. Supreme Court decision in IMS v. Sorrell, which ... read more

CMS: Sunshine Act Data Collection Will Be Delayed Until 2013

May 7, 2012 — The Centers for Medicare & Medicaid Services (CMS) stated on the CMS blog that following its ... read more

Guest Column: Heavy Meddle by Peter Pitts

May 7, 2012 — The American Recovery and Reinvestment Act (aka, “the stimulus package”) provided AHRQ with $29.5 million for ... read more

Proposed OTC Drug Distribution Would Expand Patient Access to “Rx” Drugs

April 30, 2012 – Comments are due May 7 on an FDA-proposed paradigm that would allow the agency to approve ... read more

PDUFA V Bills Moving Forward Without Specific Marketing Provisions

April 23, 2012 — The House and Senate both issued draft legislation last week to reauthorize the Prescription Drug User ... read more

CHC and TAC Comments Object to “Dual Modality” Risk Communication in DTC TV Ads

April 16, 2012 – The Coalition for Healthcare Communication (CHC) and The Advertising Coalition (TAC) recently told the FDA’s Office ... read more

ACRE Study Finds Medical Journal Discussion of Academic/Industry Relationships Unbalanced

April 12, 2012 – The Association of Clinical Researchers and Educators (ACRE) announced yesterday the publication of a study in ... read more

FDA Draft Guidance on DTC TV Ads Raises Important Questions

By John Kamp April 9, 2012 – The only thing really clear about the new guidance on pre-review of the ... read more

FTC to Industry: Adopt Consumer Privacy Best Practices Now

March 28, 2012 – Industry members needing another reason to join the fray of companies participating in the Digital Advertising ... read more

Call for Industry Comments: Proposed FDA Study on “Corrective” DTC TV Advertising

March 26, 2012 – Note to Industry Leaders The Coalition for Healthcare Communication needs your input on a study FDA ... read more

New Video Highlights Advances in CME Conflicts of Interest Policies

March 19, 2012 – A new video produced by CME Peer Review – “Conflict of Interest: The Bottom Line” – ... read more

FDA Draft Guidance on DTC TV Ads Identifies Campaigns Subject to 45-day Pre-Review Process

March 13, 2012 – Draft guidance released today by the FDA – “Guidance for Industry Direct-to-Consumer Television Advertisements” – calls ... 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

Coalition Calls for Substantial Revisions to Sunshine Act Proposed Rules

Feb. 16, 2012 – Further notice and comment are necessary for the implementation of Section 6002 of the Affordable Care ... read more

Digital Health Coalition Issues Guiding Principles and Best Practices to Help Lead Way on Robust Use of Social Media by Medicine Companies

Feb. 7, 2012 – Responding to patient and professional calls for more industry participation in the Internet and social media, ... read more

Digital Advertising Alliance Launches Consumer Education Campaign

Jan. 27, 2012 – The Digital Advertising Alliance (DAA) last week launched its “Your AdChoices” public education campaign to inform ... read more

MMM: CME Video Addresses Conflict of Interest

Jan. 26, 2012 – Avoiding conflict of interest in continuing medical education (CME) may seem like a daunting task, but ... read more

Does Novo Nordisk’s Victoza + Paula Deen = Recipe for Success?

Jan. 20, 2012 – Common sense should tell people that some of celebrity chef Paula Deen’s infamously unhealthy dishes – ... read more

Sunshine or Rain?

By Jack E. Angel, Education Foundation Executive Director, Coalition for Healthcare Communication Jan. 17, 2012 – The Affordable Care Act ... read more

MMM Features Kamp’s Call for Industry Leadership on Off-label, Online Communications

 Jan. 6, 2012 — This article, written by Coalition for Healthcare Communication Executive Director John Kamp, was featured in the ... read more

FDA Issues Draft Guidance on Unsolicited Off-label Info Requests, Addresses both Professional and Internet Media

Jan. 2, 2012 – In the waning days of 2011, the FDA released a significant draft guidance on company responses to ... read more

FDA Approval Report Contains Good News for Patients and Industry

  By John Kamp, Executive Director, Coalition for Healthcare Communication – Nov. 7, 2011 – Until the research labs and ... read more

RPM Report: Pandora’s Box Officially Open as New Legal Challenges to FDA’s Off-label Restrictions Emerge

Oct. 24, 2011 – After the U.S. Supreme Court struck down speaker- and content-based restrictions in Sorrell v. IMS Health, ... read more

Par Pharma Case Asserts That First Amendment Protects Truthful Off-label Speech

Oct. 18, 2011 – A case filed by Par Pharmaceutical, Inc. against the FDA seeks to preserve Par’s First Amendment ... read more

Kamp on the Sunshine Act: Collaboration Key to Patient Care

Dec. 14, 2011 — UPDATE — CMS has published the proposed rules enforcing the Sunshine provisions of the Affordable Care ... read more

Experts Weigh In on Implications of Sorrell Decision

Aug. 1, 2011 — The recent Supreme Court decision in Sorrell v. IMS Health Inc. is earning robust commentary in ... read more

Academic Detailing and Health Plan Communications: Is the Playing Field Level?

By Kenneth P. Berkowitz, Esq. July 21, 2011 — Why does the government fail to apply current regulatory requirements and ... 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

Kamp Column: Industry Must Embrace Internet and Social Media or Become Irrelevant in Many Health Conversations

By John Kamp, Executive Director, Coalition for Healthcare Communication June 29, 2011 — Yesterday I had the pleasure of moderating ... read more

PhRMA Survey Shows That Physicians Value Industry Communication

March 31, 2011 — At a time when interaction between biopharmaceutical companies and physicians is under increased scrutiny, a recent ... read more

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Pitts to Med Policy Pros: Academic Detailing Is Not a Panacea

From DrugWonks.com:

In a recent blog entry on DrugWonks.com, Peter Pitts, president of the Center for Medicine in the Public Interest, called out the federal government for putting its focus on and committing its dollars to programs that support “academic detailing,” a practice largely conducted by pharmacists to help healthcare professionals better understand medical treatment effectiveness (and supposedly to counter detailing done by pharmaceutical companies).

According to Pitts, although the federal government has awarded five academic detailing grants, funded in part with $29.5 million under the American Recovery and Reinvestment Act, “only a few small studies demonstrate that academic detailing reduces overall healthcare costs (direct and/or indirect) – and most only demonstrate reduced prescription drug expenditures.”

Further, he explains that measuring only drug expenditures and not health outcomes is a flawed premise. “Skimping on a more expensive medicine today but paying for an avoidable hospital stay later is a fool’s errand,” Pitts notes. Indeed, he cites a New England Healthcare Institute estimate that $290 billion in healthcare expenditures could be avoided if medication adherence were improved.

In Pitts’ view, there are number of unasked and unanswered questions regarding academic detailing, including what safeguards are in place to make sure unbiased information is disseminated, which information should be allowed in academic detailing programs, and what the ramifications of off-label academic detailing and other enforcement issues are. “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…detailers.”

Another important idea has been advanced by Ken Berkowitz, veteran industry activist and member of the Legacy Board of the Coalition for Healthcare Communication. Berkowitz has called for FDA regulation of academic details, including limits on off-label discussion. It is unfair and bad public policy, Berkowitz argues, to allow non-sponsors to include messages not approved by the FDA.

Please add your comments on this important topic below.

Read more on their website

Journal Editor Spells Out Legitimacy of Physician-Industry Relationship

With the amount of negative attention lately surrounding relationships between physicians and industry, some doctors have had enough. In response to the recent criticisms, Bradley P. Knight, MD, FACC, FHRS, Editor-in-Chief of the Electrophysiology Lab Digest, wrote an article defending the “Legitimate Relationships Between Physicians and Industry.”

Read a summary of the article in Tom Sullivan’s Policy and Medicine blog. Sullivan includes a link to the full text of Dr. Knight’s article.

UPDATE: Supreme Court will decide if Rx data use ban violates the First Amendment

January 7, 2011– The United States Supreme Court today will hear First Amendment appeal to Vermont’s Rx data use ban.

Earlier  First Circuit federal appeals court decision set up the Supreme Court appeal.

Late last year, the 2nd Circuit Court  invalidated the Vermont version of the Rx data restriction law, finding it a violation of the First Amendment.  This 2nd Circuit decision is contrary to  a 1st Circuit Court decision on similar facts, setting up the  US Supreme Court appeal granted today.   Although a victory in the Supreme Court is not assured,  the Supreme Court has fiercely protected commercial speech in virtually nearly every case before it since  the “Central Hudson” test was announced by the Court in the 1970′s.

Professor Epstein Says Conflict of Interest Policies Endanger Medical Progress and Cures

From Manhattan Institute:

An active partnership between science and commerce underlies Americans’ high standard of living, including their state of health and the medical discoveries and treatments that have steadily improved it. But a mounting wariness toward collaborations between employees of research institutions and public agencies and those working for pharmaceutical companies and the like, as expressed in increasingly broad conflict-of-interest rules and prohibitions, threatens to disrupt what has been a wide-ranging and productive exchange of knowledge and information.

Read more on their website

Richard Myer: A HCP’s Response to the PLoS Study That Pharma Marketing Increases Rx’s

From World of DTC Marketing:

The PLoS study reveals the obvious: pharmaceutical marketing affects prescribing. Pharma would not spend all the money they do on marketing if it didn’t work. In addition, they have a fiduciary responsibility to their shareholders to make providers (and some might argue the public) aware of their products.

Read more on their website

Commercial Support for CME May Rise in Response to Health Care Reform

From Medical Marketing & Media:

Industry support for continuing medical education (CME) has been waning the last 2 years, but some say the bottom may be in sight.

“My own guess is that we’re near the bottom for commercial support dollars, and that within the next few years we’ll be reporting increases, not decreases in the amount of industry funding of certified CME,” said John Kamp, executive director, Coalition for Healthcare Communication.

Read more on their website

Required Reading: Lilly Issues 52-Page Report on Value of Medicine

From Lilly:

Lilly is committed to providing “Answers That Matter.” That means not only discovering and developing innovative medicines – which we believe offer the best value in healthcare – but also engaging in ongoing dialogue with patients, providers, payers, and the public. Our vision at Lilly is to deliver improved outcomes for individual patients.

Read more on their website

Coalition Supports FDA Revision of Patient Information Requirements

In our informative slideshow, John Kamp, executive director of the Coalition, discusses steps the FDA should take to improve the information required to be given patients when prescribed a drug. The topics covered in the slideshow include

  • Who We Are, Mission & Passions
  • FDA Correctly Seizing the Moment
  • Bold Action Needed
  • What Needs to Happen
  • How Can We Help?

View the slideshow

We invite comments!

New York Times Provides an Analysis of Why Pharmaceutical Companies Should Not Be Barred From Participating in CME

Read this article on Tom Sullivan’s Policy and Medicine blog 

…then please come back here and comment.

Associations React to NIH-Proposed Conflict of Interest Rules

National Institutes of Health (NIH) has proposed new rules to amend its regulations on the “Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service (PHS) Funding is Sought and Responsible Prospective Contractors.”

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