In recent years, pharmaceutical companies’ commercial teams have faced a growing number of challenges in the market. These organizations have already faced two major patent cliffs, both of which filled the market with a number of generics and biosimilars alongside an increasing contingent of branded competitors. Now, sales representatives are seeing more and more doctors close their doors to pharma’s commercial forces in response to the Physician Payment Sunshine Act. In the wake of these challenges, pharmaceutical sales teams have had to evolve their traditionally product-centered commercial models to better meet their customers’ demands. Continue reading
The US Sunshine Act is probably among the more well-known regulations governing the life science industry’s interactions with physicians and other healthcare community members. However, when it comes to physician payment reporting obligations, the United States is not the only country with a little sunshine to spare. Many other countries have also recently drafted or enacted physician payment disclosure requirements of their own. Continue reading
Investigator meetings engage, educate and synchronize investigators before a clinical trial begins. These meetings may have been extravagant in the 1990s, but increased physician-pharma interaction regulations now monitor how much money companies spend on investigator meeting budgets. To avoid compliance troubles, investigator meetings should be comfortable but not ostentatious. Continue reading
I play video games often in my free time and hold a particular love for the Portal series. At the end of the first game, there is a cute song that contains the line, “We do what we must because we can.” There aren’t many similarities I can find between pharma and the fictional Aperture Science company from the games (pending any news regarding armies of mantis men). But that particular line lies parallel to the situation in which many companies find themselves as the digital age continues to bloom. Medical publications transparency, in particular, is one area in which several companies are only beginning to actually do what they must. Continue reading
GlaxoSmithKline recently announced that it will create an internal team of doctors tasked with educating peers about its products. In December 2013, GSK decided to stop hiring external speakers. The company hopes that “hiring doctors and medical experts to speak as in-house representatives of Glaxo will provide more transparency,” according to Deirdre Connelly, GSK president, North America pharmaceuticals. The decision to form an internal education team underscores the importance of engaging physicians in discussions regarding product efficacy. When making prescribing decisions, physicians look to well-respected peers to affirm their choices as they seek to treat patients using the best possible options. Continue reading
Teams within medical affairs often have substantial trouble gaining management buy-in and, as a result, don’t often receive the resources that they need. Although most marketing and sales functions can use hard numbers to prove their value to the company, medical affairs is often completely barred — whether legally or by company policy — from tying their work to financial gain. Most medical affairs functions need to turn to soft medical publications performance metrics to demonstrate value and obtain the resources they need. Medical publications teams were no different — until recently. Continue reading
After the Sunshine Act was released and a Final Rule was issued in early 2013, pharmaceutical companies geared up to make sure that their reporting and disclosure systems were in good working order. Determining fair-market value (FMV) for services provided is an ongoing effort. Continue reading
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.
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 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