Subscribe   RSS Contact Us

WLF to CMS: Deem Medical Textbooks Educational Materials or Face Potential First Amendment Challenge

May 16, 2013 – The Centers for Medicare & Medicaid Services (CMS) is likely “to find itself the target of ... read more

Kamp in MMM: Off-label Is on the Table

May 14, 2013 — In a Medical Marketing and Media (MMM) column posted May 1, Coalition for Healthcare Communication Executive ... read more

Next OPDP Webinar Will Address Five Months of Enforcement Actions

May 14, 2013 — The FDA’s Office of Prescription Drug Promotion (OPDP) will be holding an Enforcement Webinar May 16, ... read more

Many Physicians Are Both Unaware and Wary of Sunshine Act Requirements, Survey Says

May 6, 2013 — With Sunshine Act reporting slated to begin in less than three months, it is sobering to ... read more

Senate Commerce Committee Growing Impatient with Self-regulatory Measures

April 29, 2013 – Although the Digital Advertising Alliance (DAA) has made great strides to protect consumers’ privacy online – ... read more

Coalition: Educational Materials Should Be Excluded from Sunshine Reporting

April 22, 2013 – In April 18 comments to the Centers for Medicare & Medicaid Services (CMS) the Coalition for ... read more

White Paper Examines FDA Enforcement in Digital, Social Media Realm

April 4, 2013 – A new White Paper, “FDA Communications Oversight in a Digital Era,” issued April 2 by Eye ... read more

Policy and Medicine: News Outlets Accentuate the Negative in Describing Industry-Physician Relationships

April 4, 2013 — Headlines run by news outlets regarding the status of industry-physician relationships rarely focus on the benefits ... read more

Kamp Commentary: Supreme Court Decision Could End “Pay for Delay,” Hurt Patent Protection

April 1, 2013 – By John Kamp, Executive Director, Coalition for Healthcare Communication While not directly about communication and marketing, ... read more

Promotion Down, But Prospects Up for New Drugs

March 22, 2013 – Although spending on drug promotion has declined in recent years,  2013 could be a pivotal year ... read more

“Cyberspace Is Not Without Boundaries,” FTC States in Digital Advertising Guidelines

March 19, 2013 – Although the FDA has not yet issued its long-awaited social media guidance for the biopharma industry, ... read more

NDHI Releases Statement Outlining Four Principles for Industry/Provider Collaborations

March 11, 2013 – Healthcare industry collaborations with physicians and researchers have “been at the heart of most of the ... read more

Study Cites Benefits of Pharma’s Promotional Efforts

March 4, 2013 – A recent study released by the National Bureau of Economic Research (NBER) states that although consumer-directed ... read more

CMS Launches "OpenPayments" Site as Part of Sunshine Implementation

Feb. 25, 2013 – The Centers for Medicare & Medicaid (CMS) launched its “OPENPAYMENTS” Website last week, which will be ... read more

Sunshine Act Final Rule: Coalition for Healthcare Communication Summary

On Feb. 1, the Centers for Medicare & Medicaid Services (CMS) issued a final rule implementing the Sunshine Act provisions ... read more

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 ... read more

Coalition’s Policy Update: Keep Fiscal Challenges, Privacy Regulation on Radar

Jan. 15, 2013 – If 2012 – with its high number of new drug approvals, senior staff stability within the ... read more

OPDP Untitled Letters on PR Materials Surprise Industry

Nov. 27, 2012 – An Oct. 31 enforcement letter from the FDA’s Office of Prescription Drug Promotion (OPDP) to Cornerstone ... 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

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

Previous Next

OPDP Presents Dec. 19 Webinar on Enforcement Actions

Dec. 14, 2011 — The FDA’s Office of Prescription Drug Promotion (OPDP) will be presenting a Webinar next week to review the enforcement actions it took during this quarter. The Enforcement Webinar – the third the agency has hosted this year – will be held on Dec. 19, 2011, from 2:30 p.m. to 3:00 p.m. (ET). Viewers can begin submitting questions 30 minutes prior to the Webinar start time.

These Webinars are offered under a pilot program “in which OPDP will give our stakeholders a chance to directly communicate with the Agency on clarifications or questions about the Warning Letters and Untitled Letters issued by OPDP in a given quarter.” The Dec. 19 Webinar will cover Warning Letters and Untitled Letters issued from September 2011 to December 2011.

The Webinars are part of a pilot program that is intended to “support OPDP’s mission to protect the public health by assuring prescription drug information is truthful, balanced, and accurately communicated.”

Meeting details provided by the agency are listed below:

FOR WEB:
To join the meeting:
https://collaboration.fda.gov/ddmac3/

FOR AUDIO:
Conference Number(s): 301-796-2700
Participant Code: 252580

If you have never attended a Connect Pro meeting before:
Test your connection: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm
Get a quick overview: http://www.adobe.com/go/connectpro_overview

User Comments 1

  1. I hope this pilot develops into a good relationship that encourages clear and solid communication about these issues because we will all benefit from it.

    Bill Gustafson on Jan 12, 2012 @ 12:11AM