Subscribe   RSS Contact Us

In Amicus Brief, PhRMA Says Off-label Case “Raises Serious First Amendment Concerns”

Sept. 19, 2014 – Stating that a whistleblower’s interpretation of the False Claims Act has “a critical flaw” because it ... read more

Pfizer’s Susman to Talk Public/Private Partnerships at Nov. 10 Coalition Briefing

Sept. 19, 2014 – Sally Susman, EVP, Corporate Affairs, Pfizer, will share her insights on the importance of public and ... read more

Mark Shields to Share Political Insight at Coalition’s D.C. Meeting Sept. 23

Sept. 15, 2014 – Political analyst Mark Shields will be the keynote speaker at the Coalition for Healthcare Communication’s Washington ... read more

CMS Bombarded with Comments Calling for CME Exemption to Remain

Sept. 9, 2014 – An overwhelming majority of comments sent to the Centers for Medicare & Medicaid Services (CMS) by ... read more

Coalition Comment to CMS: Keep CME Exemption Under Sunshine Act

Sept. 2, 2014 – The Coalition for Healthcare Communication’s comment to the Centers for Medicare & Medicaid Services (CMS) asks ... read more

Open Payments Website Reopened, Dispute Period Extended and One-third of Records Withheld

Aug. 18, 2014 – The Centers for Medicare & Medicaid Services (CMS) recently announced that it had reopened its Open ... read more

Medical Groups Ask CMS to Make Changes to Sunshine Act Implementation

Doctors Recommend Fixes to CME Exemption Elimination, Educational Materials Provision Aug. 6, 2014 – More than 100 medical associations and ... 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

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

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

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

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

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

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 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

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

Previous Next

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