Life Science Compliance Update

April 24, 2017

Eighth Aggregate Spend and Sunshine Act Conference

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On June 15th and 16th, 2017, the Eighth Aggregate Spend and Sunshine Act Conference will be held at the Sonesta Philadelphia Rittenhouse Square in Philadelphia, PA. The conference has proven to be industry’s leading educational event where compliance and reporting professionals convene to discuss past submissions and upcoming changes in order to better prepare for the future.

The conference focuses on the Physician Payments Sunshine Act, which was intended to advance the life sciences industry standard of transparency, but the ambiguity of current regulatory principles continues to puzzle compliance and reporting professionals, leaving them with more questions than solutions. In addition to those issues, the actual collection of aggregate data is challenging for departments across organizations, further complicating even the most effortless tasks. Through interactive discussions and expert presentations, the conference will provide attendees with the tools needed to leverage data analytics and elevate daily operations.

Some of the conference’s featured speakers include:

  • Amie Phillips Pablo, Novo Nordisk Inc;
  • Michael O’Connor, Alexion Pharmaceuticals, Inc.;
  • Richard Velardi, Sun Pharma;
  • Michael Hunn, Draeger Medical;
  • Ishita Arora, Horizon Pharma, LLC; and
  • Gretchen Reyes Cseplo, Convatec.

According to ExL Events, the top five reasons to attend are: you will learn how to (1) uncover ways to optimize your organization’s daily operations using aggregate spend data required by the Sunshine Act; (2) comply with new CMS documentation guidelines surrounding aggregate spend reporting; (3) effectively communicate with healthcare providers across national and global data reporting landscapes; (4) consider frameworks for conducting internal audits designed to measure success; and (5) discuss best practices for leveraging your data analytics to assess compliance risk.

If you are interested in attending, you can register here.

April 03, 2017

Fourth Promotional Review Committee Compliance and Best Practices – Midwest

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On May 16th and 17th, 2017, ExL Events will host the Fourth Promotional Review Committee Compliance and Best Practices Conference at The James Chicago in Chicago, IL. The Conference is the only industry forum devoted entirely to boosting the skills and teamwork of all the stakeholders in the PRC process. Whether you are a submitter, reviewer, project manager, or meeting facilitator, this conference promises to provide you with a unique opportunity to learn and network with your peers and work to improve the cooperation, compliance, and speed of your PRC.

This year’s conference features speakers such as:

  • Denise Sanchez, Executive Director, Regulatory Affairs Advertising and Promotion, Allergan
  • John Caruso, Senior Manager, Promotion Compliance, Otsuka
  • Kevin Stark, Director, Office of Promotion and Advertising, Merck
  • Leann Bonaventura, Senior Manager, Promotional Regulatory Affairs, Medimmune

The first day starts off with a workshop on how to develop and maintain a promotional claims compendium for each product, and the official conference kicks off at 1:00 pm with an introduction, followed by panels, discussions, and case study presentations on a variety of topics focusing on new guidelines and new media for promotional review.

Day Two focuses on improving PRC teamwork and performance metrics with panel discussions and presentations. Some of the discussions include: how to prepare PRCs to respond to label changes; focus on facilitators to keep PRCs functioning smoothly; and how to leverage team member skills to enhance the PRC process. 

ExL Events cites as the top five reasons to attend, as attendees will learn: the latest methods for reassessing risk in light of First Amendment court case decisions in off-label messaging; promotional review strategy optimization for social media and adaptive websites; techniques to empower facilitators and leaders for a smoother PRC process; methods to select the ideal metrics for PRC performance improvement; and in-depth interactive workshop on developing and maintaining a promotional claims compendium.

The conference is designed for pharma, biotech, and medical device professionals who have responsibilities in the following areas: promotion review; regulatory affairs; compliance; medical affairs; communications; medical and scientific writing; and more.

If you are interested in attending, you can register here.

March 29, 2017

Chicago Releases Draft Rules on Industry Representative Licensure

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In a city where crime rates are sky-high and illegal drugs are easily picked up on the street, on November 16, 2016, the City of Chicago passed an ordinance that, effective July 1, 2017, requires pharmaceutical sales representatives to become licensed before they can promote prescription drugs to health care providers within city limits. 

Mayor Rahm Emanuel states that the new licensing requirement is part of a larger series of efforts by the city to combat heroin and opioid addiction. However, the law will impose significant new burdens on any pharmaceutical manufacturer with sales representatives who call on health care providers in Chicago.

The draft rules for this ordinance were released on March 17, 2017.

These recently-released draft rules provide additional detail regarding the licensure requirements as well as other associated education and disclosure requirements with which pharmaceutical representatives will be expected to comply beginning in July of this year.

To obtain their initial licensure as a pharmaceutical representative, applicants must complete an online course, for which proof of completion must be submitted. The cost of the initial license will run each representative $750. Then, to maintain the license, representatives must complete a minimum of five hours of continuing professional education every year thereafter. 

Approved providers for continuing professional education can be found on the city’s website. Making this burden even more onerous, continuing education provided by pharmaceutical manufacturers to their employees will not be accepted as fulfilling the requirement, unless the manufacturer previously applied for, and received, approval. A licensed representative who does not meet these continuing education requirements may face substantial penalties, including suspension or revocation of the license, inclusion in a public list of representatives whose licenses have been revoked, and/or a fine between $1,000 and $3,000 per day of violation.

In addition to the professional education requirement, pharmaceutical representatives will also be required to track and report certain sales information on an annual basis or upon request by the Commissioner of Public Health. This information must include: a list of the health care professionals who were contacted, the location and duration of each contact, the pharmaceuticals that were promoted, and whether product samples or any other compensation was offered in exchange for the contact.

For applicants who receive initial licensure, the time period for the data that must be collected and reported shall cover an 11-month period, starting on the first day of licensure and exactly ending one month before its expiration. For representatives with a renewed license, the data shall cover a 12-month period that will begin one month before the license renewal and will end one more before its expiration.  If the Commissioner of Public Health requests the information at any other time, the request will designate the time period the submission must cover, and it will be due within 30 days of the request.

A pharmaceutical representative who is found to have violated any provision of the Ordinance or these rules will be subject to suspension or revocation of licensure and/or a fine of $1,000 to $3,000 per day of violation. Inexplicably, once a license is revoked, it cannot be reinstated for a period of two years from the date of revocation.

These new requirements will place a significant burden on pharmaceutical manufacturers and their sales representatives who work in Chicago. Late last year, in an attempt to prevent the ordinance from going into effect, a coalition of sixteen pharmaceutical companies, along with organizations such as the Illinois Chamber of Commerce, the Illinois Manufacturer’s Association, the Epilepsy Foundation of Greater Chicago, and the Pharmaceutical Research and Manufacturers of America, wrote a letter to the City Council of Chicago expressing its concerns. The group noted, “[t]hese proposed reporting requirements are unnecessary and duplicating, creating an unnecessary tax on one of the most important sectors of our economy.”

The public is invited to submit any comments it may have on the proposed rules by April 2, 2017. readers are encouraged to send in comments, especially those local to the Chicago area to submit their comments about these regulations. The pharmaceutical industry is one of the most regulated industries in the country as it is.  The FDA requires reps to distribute REMS information on drugs that their company provides.  It is not clear how tracking the office visits and amount of time spent with healthcare providers by pharmaceutical reps is in the public interest.

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