Thought Leader Segmentation Reduces Regulatory Pressures

Last month, the French version of the U.S. Sunshine Act was implemented, forcing medical device makers to report all exchanges of value to healthcare professionals in excess of €10, in a first step that will eventually spread to all life science companies. The French “Law No. 2011-2012 on Strengthening of Health Protection for Medicinal and Health Products” is retroactive to transactions from January 1, 2012. We believe a similar scenario as the one that unfolded in the US will prevail in France: a reduced pool of thought leaders available to work with device makers.
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Drug Company Research Payments Exceed Promotional Speeches

Elio Evangelista, physician fair-market value expert
By Elio Evangelista,
Senior Director

Although the government has varying motivations for requiring drug and device companies to disclose the payments they make to physicians, one consequence — intended or otherwise — is that drug company research payments have begun to exceed payments to physicians for promotional speeches.  They’re also paying less money to doctors as a whole.

ProPublica’s Dollars for Doctors database houses the physician compensation data for 15 pharmaceutical companies that have been publishing information about the payments they make to doctors as far back as 2009.  The cumulative amounts paid since then by 13 of these 15 companies total more than $2 billion.  (Allergan and Valeant have disclosed payment ranges and not fixed numbers, so they’re more difficult to include in the cumulative total.) Continue reading

Advisory Board Functions Expanding in Pharma Industry

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Senior Research Analyst

Advisory boards have been part of the pharmaceutical landscape for a long time, providing companies with valuable expert opinions on topics ranging from ensuring thorough regulatory submissions to clinical trial protocols.  This role does not look to fade anytime soon, as regulatory requirements get tougher and payers look for ever more clinical data and health outcomes to prove the value of products on the market.  Many companies are working to create a cohesive advisory board strategy – and set of advisory board functions – that encompasses which groups are best suited to handle the responsibility of coordinating advisory boards and how to achieve a useful deliverable out of a board meeting. Continue reading

Speaker Programs 2.0: Budgets Are Here to Stay

The future of speaker programs has looked murky for the past few years for several reasons: tightened budgets, increased regulatory scrutiny and heightened media attention to speaker fees — as seen in the Dollars for Docs platform and potential CME Sunshine Act reporting.  This uncertainty thrived, especially before CMS published the final rules for the Sunshine Act in early February.  However, even before the final ruling stipulated that fees for speakers for CME events will not be tracked as long as they fulfill certain requirements (such as accreditation or certification requirements), educational speaker programs were stabilizing.  The final ruling is an added boon to medical educational speaker programs, and the overall trend for speaker programs has already begun improving. Continue reading

Transparency for FMV Rates: Finding a Balance Abroad

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

When France first released its 2011 draft of the Bertrand Act — which included a provision similar to the Sunshine Act here in the US – the legislation promised to be more stringent than US guidelines.  The draft required companies to post its payments on its website within 15 days of the activity — complete with the recipient’s name and the amount he or she received.  It also required companies to deliver a report detailing their outside spending to six professional organizations — even if payments were under the US equivalent of $95.  Continue reading

Sunshine Act and the States

There has been much buzz about the Sunshine Act since the Centers for Medicare and Medicaid Services (CMS) released its final draft of guidelines.  Comparatively, there has been little mention as to how the Sunshine Act affects states.  According to Section H of the guidelines, the law will take precedence over existing state laws in situations where the national and state reporting requirements overlap.   Continue reading

Is Pharma Ready for the Sunshine Act?

At last.  Cue the Etta James music because the Centers for Medicare and Medicaid Services (CMS) released the final version of the Sunshine Act.  Is pharma ready for the Sunshine Act? As of February 8, the Sunshine Act will be included in the Federal Register and will go into effect shortly thereafter.  Finally, pharma and the rest of the healthcare industry can breathe a little easier as they shift away from eagerly — or perhaps reluctantly— awaiting further legislative updates to focusing on adhering to these now-finalized guidelines. Continue reading

Happy Holidays!

As the year comes to a close, we would like to thank our readers, clients, and partners for their contributions toward helping Cutting Edge Information create benchmarking reports for the life sciences industry.

With Sunshine Act responsibilities and continued patent cliff challenges in front of us in 2013, CEI is ready, willing and able to rise to the difficulties facing the Pharma industry. Check out our Annual Forecasting Guide to see what other trends will be impacting life sciences companies in 2013.

We look forward to serving you in 2013.

Here’s wishing everyone a safe and happy holiday season.

-The Team at Cutting Edge Information


Physician Payment Disclosures and FMV Going Strong Despite Sunshine Act Delays

Elio Evangelista, physician fair-market value expert
By Elio Evangelista,
Senior Director

The United States is still waiting for the Centers for Medicare and Medicaid Services (CMS) to issue its final ruling on how it will implement the physician payment disclosures rules outlined in the Sunshine Act. However, this has not deterred companies from continuing to make public disclosures or caused them to lose focus on determining fair-market value (FMV) physician fee schedules.

Initially, CMS was scheduled to give a ruling to drug and device manufacturers in October 2011. But the agency Continue reading