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House Energy and Commerce Committee Wholeheartedly Approves 21st Century Cures Act

May 21, 2015 – In a unanimous (51-0) vote today, the House Energy and Commerce Committee approved the 21st Century ... read more

21st Century Cures Legislation Poised for Full House Committee Vote This Week

May 18, 2015 – Major medical legislation, including closely followed provisions on off-label communication and Sunshine reporting, survived a House ... read more

FDA Plans for Off-label Communication Draft Guidance, Meeting

May 11, 2015 – With off-label provisions in the 21st Century Cures legislation in the works and the courts bearing ... read more

FTC to Industry: Consumer Health Data Subject to Privacy, Security Protections

May 4, 2015 – The Federal Trade Commission (FTC) has issued a reminder to industry members collecting, using or sharing ... read more

PhRMA Authors Call for FDA to Establish Off-label Communication Safe Harbor

April 27, 2015 – Because “sharing more information rather than less” about the off-label uses of approved drugs “is critical ... read more

FDA Draft Guidance Describes Framework for Electronic Submission of Promotional Materials

April 22, 2015 – Healthcare marketers soon will have to submit promotional labeling and advertising materials to the FDA electronically, ... read more

Changing of the Guard at PhRMA

April 20, 2015 – The Pharmaceutical Research and Manufacturers of America (PhRMA) last week announced changes to its board – ... read more

Coalition to Sponsor Medical Marketing Pitch Webinar

April 6, 2015 – The Coalition for Healthcare Communication is sponsoring a Webinar May 6 that will highlight both basic ... read more

2014 DTC Ad Spending on the Rise

March 25, 2015 – The amount of money that drug companies spent on direct-to-consumer advertising rose from $3.8 billion in ... read more

What Does OPDP’s Enforcement Lull Mean?

March 12, 2015 – The FDA’s Office of Prescription Drug Promotion (OPDP) has issued fewer enforcement letters in recent years, ... read more

Who Says You Can’t Fight City Hall?

Commentary from Jack Angel, Coalition for Healthcare Communication Education Foundation Executive Director March 9, 2015 – I am not sure ... read more

DAA Expands Ad Privacy Controls to Mobile Marketplace

Feb. 26, 2015 – To “bolster both consumer trust and marketplace growth,” the Digital Advertising Alliance (DAA) yesterday launched two ... read more

Leveraging Technology and Other Highlights from DIA Marketing Meeting

Feb. 23, 2015 – Dale Cooke, owner of PhillyCooke Consulting, who spoke Feb. 18 at the Drug Information Association’s Marketing ... read more

FDA Budget Increase Relies on Higher User Fees

Feb. 16, 2015 – Although President Obama’s proposed budget for fiscal year 2016 includes increases for both the FDA and ... 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

FDA Commissioner Hamburg to Leave FDA

Feb. 5, 2015 – After serving the FDA for six years, Commissioner of Food and Drugs Margaret Hamburg, M.D., will ... read more

21st Century Cures Discussion Draft Includes Textbook/Reprint Language, Communication Fixes

Jan. 29, 2015 – A 393-page discussion draft of legislation designed to accelerate the 21st Century Cures initiative – released ... read more

Transparency Proponents Slam Company-Provider Communication

Jan. 26, 2015 – Although biomedical companies can legally communicate and share information with physicians under the Physician Payments Sunshine ... read more

FDA Moves Forward with Major Statement Study, Responds to Coalition’s Comments

Jan. 14, 2015 – The FDA is taking the next step toward examining whether shorter, simpler risk disclosures in direct-to-consumer ... read more

Coalition: Issues to Watch in 2015

Jan. 13, 2015 — As 2015 gets fully underway, there are several issues that healthcare marketers should be following, according ... read more

Kamp to WSJ’s Pharmalot: CMS Move on CME “One of Biggest Flip Flops” Ever

Dec. 18, 2014 – This week’s release by the Centers for Medicare & Medicaid Services (CMS) of subregulatory guidance on ... read more

MM&M Tax Reform Prognosis: Stay Tuned

Dec. 4, 2014 — The looming threat of eliminating the marketing tax deduction as part of overall tax reform may ... read more

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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 Care Act clarified several areas in question in the proposed rule, unresolved issues remain and the burden placed on industry to keep records and report on funds provided to physicians and teaching hospitals is significant, according to John Kamp, Executive Director, Coalition for Healthcare Communication.

The Sunshine final rule states that manufacturers must start collecting required data on Aug. 1 of this year and report it to the Centers for Medicare & Medicaid Services (CMS) by March 31, 2014.

“There are plusses and minuses to the final rule,” Kamp said. “It ends the uncertainty we’ve lived under since the proposed rule was issued in December 2011 and removes some of the meaningless requirements to report every bagel and cup of coffee offered at general meetings, but it also states that many routine products and services provided to physicians as part of reasonable and beneficial collaborative relationships are reportable,” he noted.

In the “pro” column for the final rule, which was released by the U.S. Department of Health & Human Services (HHS) on Feb. 1 and will be published Feb. 8 in the Federal Register, Kamp lists the following:

  1. Many

    rules are explicit, clear, understandable, standardized, and actionable.

  2. The national Website reports will contain a section where buy viagra canada clients can explain the purpose and context of the payments, thus enabling the public to understand their value.
  3. Clients and doctors have new, clear systems for reporting, reviewing and resolving disputes before the reports are public.
  4. Certified continuing medical education (CME) that follows national accreditation rules explicitly is exempted both for speaker fees and the value of attendance.
  5. The value of mass media supported by advertisers appears to be exempt.
  6. New meal reporting rules exempt coffee, snacks and buffets at widely attended events.

However, there are a corresponding number of items in the “con” column:

  1. The system is extremely burdensome to administer. (CMS conservatively estimates that it will cost $269 million the first year and $180 million per year thereafter.)
  2. Many politicians, reporters and others still are likely to consider every payment indicia of a conflict of interest and will criticize industry and doctors for simply collaborating.
  3. The rules appear to require reporting of all promotional education, even mandated education under REMS.
  4. Indirect payments by agencies and publishers to known physician recipients all must be reported.
  5. The value of all formal meals and entertainment at educational and other unpaid events offered to identifiable doctors must be reported.
  6. Disputes between doctors and clients must be resolved in a very short time span or they will be reported on the registry as unresolved.

It is the government’s position that while it understands that industry/provider collaboration “contributes to the design and delivery of life-saving drugs and devices … payments from manufacturers to physicians and teaching hospitals can also introduce conflicts of interest that may influence research, education, and clinical decision-making in ways that compromise clinical integrity and patient care, and may lead to increased health care costs,” the rule’s executive summary notes. 

However, even though the rule states that “financial ties alone do not signify an inappropriate relationship,” industry has reason to be concerned that these ties will be viewed negatively, Kamp explained.

“With these rules in place, the press and some politicians must stop treating reported payments as indicators of some sort of scandal,” he said. “Collaboration between industry, physicians and academicians has led

to great medical breakthroughs in the past, so driving a wedge between these parties will hurt, not help patients. Transparency is good, but it must be clear to the public that a physician who collaborates with industry is not doing anything wrong.”

CMS will be accepting public comment on the final rule for 45 days.viagra 100 mg