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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July 1, 2014 – The FDA’s recently issued draft guidance on medical device data systems (MDDS) not only lessens the ...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June 23, 2014 – Although the two social media draft guidance documents the FDA’s Office of Prescription Drug Promotion (OPDP) ...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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New Healthcare Podcast: "Social Media: Approach with Caution"

The Coalition and Med Ad News are collaborating on a series of podcasts by John Kamp, Coalition Executive Director, on topics vital to the healthcare communication industry. The 4th podcast, “Approach with Caution,” is now available for download. In this segment, Mr. Kamp talks about social media, why legal departments will continue to voice strong resistance to going too far and he also acknowledges the great opportunity social media hold in improving the industry relationship and reputation with consumers.

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All 4 podcasts can be downloaded here: prednisone for sale

Executive Director of Coalition Says Stark Proposals Violate the 1st Amendment

From Washington Legal Foundation:

On June 21, 2007, U.S. Representative Pete Stark introduced a bill titled the “Fair Balance Prescription Drug Advertisement Act of 2007.” H.R. 2823 (110th Cong., 1st Sess.). If enacted, the bill would deny a tax deduction for any expenses associated with a direct-to-consumer (“DTC”) advertisement for a new prescription drug for the first 2 years after approval.

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Coalition and Med Ad News Present Healthcare Podcasts

You can visit to download podcasts on healthcare issues by John Kamp, the Coalition”s Executive Director.

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The 1st is on the defeated but still looming ad tax bill. The 2nd is an overview and analysis of the “New FDA.”

Med Ad News plans to present 3 more podcasts in this series.bayer cipro prostatitis

MM&M Profiles Tom Sullivan, a Forceful Defender of CME

The February issue of MM&M magazine spotlights Policymed.com blogger Tom Sullivan.

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Sen. Grassley Wants An Accounting of Pharmaceutical and Medical Device Company Contributions

Continuing his “ongoing probe into conflicts of interest,” Senator Chuck Grassley this week sent letters to the American Medical Association, Alzheimer’s Association, the American Cancer Society and 30 other disease and medical advocacy organizations asking them to provide details about the amount of money that they and their directors receive from drug and device makers.

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Read more, including Senator Grassley’s letter, in Thomas Sullivan’s Policy and Medicine Blog.

Outgoing NJ AG Report Recommends Further Limits to Physician-Industry Relationships

In one of her final acts as NJ Attorney General, Anne Milgram’s office has issued a new report, “Physician Compensation Arrangements,” recommending limitations to physician-industry relationships for state agencies that go above and beyond guidelines outlined by PhRMA and other organizations.

The Coalition Speaks Out on New DTC Research Analysis

Coalition Statement – DTC Advertising:

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Recent news coverage regarding a Harvard Medical School study showing correlation between Plavix price increases for Medicaid programs in 27 states and direct-to-consumer advertising costs is unfounded. As study authors concluded, DTC advertising was not associated with an increase in Plavix use above preexisting trends.

Washington Ad Coalition Urges Renewed Contacts to Senators to Stop Ad Tax

As expected, the Ad Tax is back on the table as part of the pending healthcare reform legislation. Jim Davidson, head of the Advertising Coalition, is recommending calls to U.S. Senators urging REJECTION of the medical advertising tax proposal of Senator Franken-MN and 2 cosponsors, Senators Whitehouse-RI and Brown-OH.

Ad Coalition to Senators: Ad Tax Bill Is Unconstitutional

Today, the Coalition sent letters to Senators Franken, Whitehouse and Brown specifying multiple reasons not to allow passage of s1763, the Ad Tax Bill. Read the letters, then feel free to comment.

Senator Franken to Offer Rx Ad Tax Amendment. No joke.

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