Subscribe   RSS Contact Us

FDA Approval of 35 Novel Drugs Is Sign of Progress

Dec. 19, 2014 – The FDA announced last week that its Center for Drug Evaluation and Research (CDER) so far ... 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

Bennet/Hatch MEDTECH Bill to Maximize Benefit of Medical Electronic Data

Dec. 15, 2014 — The “Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act” introduced recently by U.S. Senators ... 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

21st Century Cures Initiative to Spur Innovation, Improve Communication

Dec. 1, 2014 – Last week House Energy and Commerce Committee Chairman Fred Upton (D-Mich.) and Rep. Diana DeGette (D-Colo.) ... read more

Doctors Weigh In on Importance of Journal Reprints, Passing H.R. 5539

Nov. 26, 2014 – Several physicians speaking at a recent meeting held in Washington, D.C., said that journal reprints, medical ... read more

Kamp: 2014 Election Results Will Have Impact on Medical Marketing

Nov. 14, 2014 – Tax reform, privacy legislation, Sunshine Act implementation and FDA/HHS enforcement and emerging policies all are issues ... read more

CMS Reinterprets Sunshine Act Final Rule to Exclude Certified CME Costs from Reporting

Nov. 3, 2014 – The certified continuing medical educations (CME) community got a “treat” on Oct. 31, when the Centers ... read more

The Elections Are Over: What Does It Mean for Healthcare?

Oct. 28, 2014 — Join us for a Webinar on Nov. 12! John Kamp, Executive Director of the Coalition for ... read more

FDA Response to MIWG Shows Willingness to Revisit Off-label Speech Policies

Oct. 27, 2014 – As members of Congress prepare legislation that may establish the conditions under which companies can share ... read more

House Legislation to Tackle Thorny Off-label Issues

Oct. 20, 2014 – It is looking like Congress may attempt to settle whether companies can speak truthfully about their ... read more

Bipartisan Bill Seeks Fix to Formalize Textbook/Reprint Sunshine Act Exclusions

Oct. 14, 2014 – After multiple efforts failed to convince the Centers for Medicare & Medicaid Services (CMS) that peer-reviewed ... read more

PhRMA, BIO, AdvaMed Tell FDA Social Media Guidance Is Lacking, Violates First Amendment

Oct. 6, 2104 – Although the FDA’s Office of Prescription Drug Promotion (OPDP) recently reopened the comment period for its ... read more

Social Media Master Class Helps Companies Navigate Compliance

Sept. 30, 2014 – Companies striving to use social media marketing both effectively and appropriately likely will benefit from a ... read more

Coalition Panel: Data Regulation Focus Shifting from Privacy to Security

Sept. 29, 2014 – The federal government’s efforts to severely limit the ability of industry to gather and use online ... read more

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

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

CHC, MassBIO and PhRMA Support Mass. Emergency Amendments to Allow Modest Meals at Non-CME Events

Oct.

22, 2012 – At a hearing held Friday in Boston by the Massachusetts Department of Public Health, representatives from the Coalition for Healthcare Communication, the Massachusetts Biotechnology Council (MassBio) and the Pharmaceutical Research and Manufacturers of America (PhRMA) testified that the state’s emergency amendments making an exception to a 2008 gift ban to allow “modest meals” to be offered order viagra usa to healthcare professionals is both supported by their organizations and in line with

industry and federal standards. [Click on name links to view full testimony.]

“The Massachusetts Department of Health correctly recognized that the most important need here is to facilitate education for drug prescribers,” said Coalition Executive Director John Kamp after the hearing. “The common sense provision of a modest meal at a dinner meeting is merely a way to facilitate the safe and effective use of medicine.”

Although the Coalition “takes that as a given, it found it necessary to respond to critics of the change who made irresponsible allegations that company-sponsored education was unregulated and often led to improper prescribing,” he said.

The Oct. 19 hearing follows July revisions to the 2008 Pharmaceutical and Device Manufacturer Code of Conduct (PCOC) as part of the 2013 state budget. In September, the Massachusetts Public Health Council set forth amendments that would allow meals to be offered at non-CME presentations for healthcare professionals outside of the office or hospital setting.

The amendments proposed the following definition: “Modest Meals and Refreshments, food and/or drinks provided by or paid for by a pharmaceutical or medical device manufacturing company or agent to a health care practitioner that, as judged by local standards, are similar to what a health care practitioner might purchase when dining at his or her own expense.”

PhRMA “believes that the emergency amendments will facilitate the ability of pharmaceutical manufacturers to offer company-sponsored speaker programs that educate and inform health care practitioners about the benefits, risks, and appropriate uses of their products and to engage in other informational discussions with physicians,” said Marjorie Powell, senior assistant general counsel, PhRMA.

Further, PhRMA “appreciates” the emergency amendments’ flexible standard for determining whether a meal is modest, and that the definition of modest meals is consistent with the PhRMA Code, which states that “speaker programs may include modest meals offered to attendees and may occur in locations outside of the office or hospital setting, as long as they occur in a venue and manner conducive to informational communication.”

MassBio President and CEO Robert K. Coughlin also praised the amendments as “very narrowly tailored but important revisions to the law that now provide our members with further critical opportunities to educate health care professionals on important aspects of medical science, treatments and therapeutics.”

Kamp stated on behalf of the Coalition that the “singular goal” of his comments “is to dispel the myth promulgated by some that company-supported education is pure selling and is unfettered by regulation or full company responsibility for the truth, veracity or ‘fair balance’ of the content of the presentations. Nothing could be farther from the truth.”

When addressing the specific language in the modest meal definition, PhRMA recommended that Massachusetts revise its definition to refer to what a “typical” healthcare practitioner might purchase when dining at his or her own expense. “This additional language would ensure that companies are able to conduct a single evaluation of whether a particular meal is modest,” according to Powell.

She also raised some issues regarding how the amendments would dovetail with Sunshine Act requirements (which preempt state law) and how Massachusetts disclosure reports should be drafted to coordinate with federally mandated Sunshine Act disclosure reports. While noting that company-sponsored speaker programs “are critical to the safe and effective use of prescription drugs,” Powell also stated that companies might have opportunities to interact with healthcare practitioners in other contexts as well, which Massachusetts should consider when crafting the final rule.

Overall, Coughlin stated that the definition of modest meals “strikes a thoughtful and effective balance: it holds the industry accountable through transparency while also providing further opportunities to life sciences companies – some of whom are small and not yet profitable – to engage with the medical community in a controlled manner that is critical for the further development of the life sciences and the achievement of novel therapies that advance not only our economic health, but also the health of our citizens.”

Kamp pointed out that company-sponsored educational events are fully regulated by the federal Food and Drug Administration, state consumer protection statutes, state codes (including the Massachusetts code), federal “false claims” and other statutes, the threat of possible plaintiff “failure to warn” law suits, and the self-regulatory guidelines of PhRMA, BIO and AdvaMed, the three leading industry trade associations. In other words, according to Kamp’s testimony, “the laws of the federal and state governments … and the internal policies of companies are stringent and work to ensure that these programs are both educational and in accordance with good care.”

“As we said in Boston, these sessions are strictly regulated and provide information that is essential to the safe and effective use of drugs,” Kamp said.

The Massachusetts Department of Public Health will now consider the hearing testimony and written comments on the proposal. The regulation will be voted on by the Council at its Nov. 14 meeting and will be filed with the Secretary of the Commonwealth. The final regulation will be effective as published on Dec. 7.

Results 1-1 of 1