Life Science Compliance Update

« July 2013 | Main | September 2013 »

28 posts from August 2013

August 30, 2013

Physician Payment Sunshine Act: Doctors Bracing for Increased Public Scrutiny

The Wall Street Journal recently reported on the Physician Payment Sunshine Act. The Journal noted that doctors are "bracing" for increased "public scrutiny of the payments and gifts they receive from pharmaceutical and medical-device companies as a result of the new health law."

As we have reported numerous times, the Journal broadly summarizes the Sunshine Act: "Starting this month, companies must record nearly every transaction with doctors—from sales reps bearing pizza to compensation for expert advice on research—to comply with the so-called Sunshine Act provision of the U.S. health-care overhaul. The companies must report data on individual doctors and how much they received to a federal health agency, which will post it on a searchable, public website beginning September 2014."

Doctors worry the public will "misinterpret the information." Others fear: "patients will view the payments as tainting their medical decisions, and will lump together compensation for research-related services with payments of a more promotional nature."

Dr. John Mandrola

The story notes the experience of one doctor, John Mandrola, a cardiologist in Louisville, KY. Dr. Mandrola says he has been paid a total of: "$1,500 to $2,000 this year by medical-device makers for speaking engagements." Knowing that such transactions will become public has caused him to be more cautious about what fees to accept, he said. He avoids industry reps visiting his office, believing he can get information on new drugs elsewhere.

"I'll continue to weigh the benefits and the negatives, and I think the Sunshine Act and the public reporting of all this stuff makes us think about that," said Dr. Mandrola. "And I think that's a good thing."

Dr. Mandrola addressed the benefits of added transparency, but notes that the disclosures: "could squelch legitimate interactions—for example, when doctors receive consulting fees to help companies develop drugs and determine their best use."

"I don't think all physician-industry interaction is bad," he said.

Dr. Mandrola's follow-up

Posting on MedCity News, Dr. Mandrola added more context to his quotes in the Wall Street Journal. Dr. Mandrola writes:

"Doctors are a conservative lot (a good thing for patients), so yes, it is likely that things will change. Concern over perception will surely decrease physicians' interactions with industry, both the useful and not so useful ones. Do we really want the industry responsible for innovative medical products blowing money on keeping spreadsheets of how many free burritos someone is getting?

The effect on physician education might suffer. Though the Ben Goldacre's of the world rightly emphasize bias when industry entwines itself with medical education, I can attest to have learned a lot from industry-sponsored programs–like the echo conferences a decade ago. And this too: one thing that happens when industry sponsors a learning session is that doctors come to it. They talk; they share cases; they come together face-to-face. Such interactions are critical. Will the disappearance of sponsored sessions decrease the amount of face-to-face learning? Yes it will. Maybe social media can fill the face time void. And maybe not. A chilling effect on physician education should not be minimized.

There is one exception to the Sunshine Act that deserves emphasis: If industry gives money to a medical society as an unrestricted grant, the society can then use the money to pay speakers without disclosure. As long as the money is not ear-marked, no disclosure is required. Influence leaders, therefore, can continue to be paid for influencing. If the ultimate goal of the Sunshine Act is to improve transparency or perhaps even decrease utilization of expensive medical care, this loophole seems an important one.

And the final irony: Deep down, I believe that less is more in medical care. Changing the culture of American Medicine from one that disrupts so much to one that disrupts a little less will ultimately improve societal health. Alas, the problem is that it's all so nuanced. The Sunshine Act may help sharpen some lines, but in the care of other humans, the lines will always remain blurry."

Other drug and device makers

The Journal further notes that several drug and device makers have been posting physician-payment data online for the past few years. Some U.S. states already require companies to report such information. But the Sunshine Act will significantly widen the scope because it applies to most companies—any company whose products are covered by Medicare—and the government's launch of the database could draw greater public attention.

Richard B. Aguilar, a diabetes-care specialist, received a total of $42,339 from Lilly for the first three months of 2013, according to Lilly's online payment database. Dr. Aguilar, who has a private practice in Downey, Calif., said he speaks about Lilly drugs at programs to teach other doctors, and the information is consistent with the FDA-approved prescribing labels. He says the payments are fair compensation for his expertise and travel. Dr. Aguilar plans to continue serving as a paid speaker, but he says other doctors are increasingly opting out of attending or speaking at such programs for fear of what the public will think about the payment disclosures.

Dr. Aguilar said he hopes the public would see the value of physicians learning new information about drugs from an expert at speaker programs, rather than having to rely upon their own educational resources to keep current. "This, in essence, is reducing the number of valuable expert educational speakers who might otherwise have provided teaching and experience to many health-care providers," he said.

Some doctors fear the payment data will be inaccurate and could mislead the public about the nature of their relationships with the industry. Gary M. Cowan, an ophthalmologist in Fort Worth, Texas, said he has occasionally attended company-sponsored dinners to hear a lecture from an expert in his field. He plans to monitor the payments that companies report in his name.

"I think it behooves every physician to look and see what's said about him," he said.



August 29, 2013

CBI Forum on Independent Medical Education and Grants 2013 – Includes Give and Take Sunshine Panel

Now in its 11th year, CBI's Forum on Independent Medical Education and Grants offers a deep dive into topics related to the regulatory landscape, stakeholder expectations, effective needs assessment, outcomes management and more! Convening more than 400 supporters, providers, medical societies and associations over the years, this is the go-to event for benchmarking and networking with industry leaders. 

Join industry professionals September 10-11 in Philadelphia to participate in the most interactive forum yet, including a participatory education workshop, rotating roundtable series and customized tracks for pharma/biotech and medical device companies. You'll hear from commercial supporters and providers representing more than 20 companies.

Registration can be completed at this link.

To learn more, please see the following link. A brochure for the Forum can be found here.

Key topics to be addressed include:

  • Making sense of and interpreting the Sunshine Act – The evolving impact on both CME and non-CME initiatives
  • Supporter/provider collaboration to align expectations
  • Understanding your learner's key objectives
  • Outcomes debate on expectations vs. reality
  • CME perspective on the advent of ACOs
  • Monitoring and auditing programs through needs assessment

Who Should Attend?

Primary Audience Titles and Types of Companies:

This conference would be of interest to Vice Presidents, Executives, Senior Directors, Directors and Managers at pharmaceutical, biotechnology or medical device companies with responsibility in the following areas:

  • Grants
  • Continuing Medical Education/CME
  • Medical Communications
  • Compliance
  • Medical Affairs
  • Clinical Affairs
  • Regulatory Affairs
  • eLearning
  • Counsel
  • Academic Affairs
  • Legal
  • Scientific Affairs
  • Medical Research

Secondary Market Titles and Types of Companies:

This conference would also be of interest to consulting companies, academics, researchers, etc. who work with the above groups to solicit for or are the beneficiaries of grants from bio/pharmaceutical and medical device companies.

Of particular note to Policy and Medicine readers is the Sunshine Panel:

"Give and Take" Sunshine Panel – Making Sense of and Implementing Sunshine Reporting Data

2012 has been a monumental year for the Physician Payment Sunshine Act, with the release of the final regulations in February and the August 1st deadline to start reporting. While accredited CME programming was, for the most part, excluded from the reporting mandate, non-CME activities were not. This decision may play a large part in determining future strategies -- Will companies continue to fund non-CME programs or will they move away from this to avoid the associated "reporting headaches"? How will stakeholders handle meal reporting for covered entities? This panel takes a deep dive into both supporter and provider interpretations of the Sunshine Act, examines how it is impacting day to day responsibilities and forecasts the future of both CME and non-CME programming.

The Panel Will Discuss:

  • Sunshine wrap up – Where does industry stand now? What process and behavioral changes has this dictated?
  • Impact on pharma, device and providers
  • Implications for reporting at satellite symposia and programs with covered entitles
  • Considerations for honoraria, travel, food and beverage, giveaway materials
  • Opt in vs. opt out for plated meals
  • How to handle sign-in sheets
  • Notifications for information being reported

Moderator: Patricia Jassak, MS, RN, CCMEP, Director, IME and Advocacy Development, Astellas Scientific and Medical Affairs, Inc.

Panelists:     Marc Eigner, Partner, Polaris Management Partners

Thomas Sullivan, President, Rockpointe

Leah Omar, Senior Compliance Specialist, Medtronic, Inc.

NIH To Support Big Data to Knowledge Centers of Excellence

NIH announced that it will fund up to $24 million per year for four years ($96 million total) to establish six to eight investigator-initiated Big Data to Knowledge Centers of Excellence. The centers will improve the ability of the research community to use increasingly large and complex datasets through the development and distribution of innovative approaches, methods, software, and tools for data sharing, integration, analysis and management. The centers will also provide training for students and researchers to use and develop data science methods.

Biomedical research is increasingly data-intensive, with researchers routinely generating and using large, diverse datasets. Yet the ability to manage, integrate and analyze such data, and to locate and use data generated by others, is often limited due to a lack of tools, accessibility, and training. In response, NIH launched the Big Data to Knowledge (BD2K) initiative in December.

This initiative supports research, implementation, and training in data science that will enable biomedical scientists to capitalize on the transformative opportunities that large datasets provide. The investigator-initiated BD2K Center of Excellence funding opportunity is the first of several BD2K funding opportunities to be announced in coming months.

"BD2K aims to enable a quantum leap in the ability of the biomedical research enterprise to maximize the value of the growing volume and complexity of biomedical data," says Eric Green, M.D., Ph.D., NIH acting associate director for data science and director of the National Human Genome Research Institute. "The Centers of Excellence will provide a key component of the overall initiative."

By encouraging the formation of interdisciplinary teams in a collaborative environment the BD2K Centers of Excellence also seek to increase the involvement of investigators outside of traditional biomedical areas who are experienced with data science.

"This funding opportunity represents a concerted effort to leverage the power of NIH in developing cutting-edge systems to address data science challenges," said NIH Director Francis S. Collins, M.D., Ph.D. "The goal is to help researchers translate data into knowledge that will advance discoveries and improve health, while reducing costs and redundancy."

Applicants responding to the BD2K Center of Excellence funding opportunity announcement should identify a research topic and propose research in data science. They should develop approaches, methods, software, and tools for data integration, analysis, database development and management, and visualization and modeling to address important research questions. The products from this research and development will be shared and distributed broadly to the research community. The centers are expected to interact as a consortium that cooperatively builds on individual research efforts.

An information webinar for prospective applicants will be held on Thursday, Sept. 12, 2013, from 3 p.m. to 5 p.m. EDT. More details about this event and the overall BD2K initiative can be found at Applications will be due on Nov. 20, 2013.

In other news, NIH announced in July that due to the "unstable regulatory environment" in India, it has cancelled almost 40 ongoing clinical trials taking place in the country.

The unstable regulatory environment is one reason why "sponsors are being driven away to places like Malaysia and Canada," reported BioSpectrum.

"The move comes as the health ministry, after the Supreme Court's intervention, tightened regulatory norms for trials. The health ministry amended the Drugs and Cosmetics Act with new laws for regulation and ethical supervision of trials; compensation of trial subjects; and mandatory accreditation of all stakeholders—institutional review boards, research institutions, sponsors and contract research organizations."


Preview | Powered by FeedBlitz


April 2018
Sun Mon Tue Wed Thu Fri Sat
1 2 3 4 5 6 7
8 9 10 11 12 13 14
15 16 17 18 19 20 21
22 23 24 25 26 27 28
29 30