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The Week That Was

The Week That Was

July 31, 2017 0 Comments

Our team spent some time in Washington last week, and despite the cooler temperatures, we definitely felt the healthcare heat. While “skinny reform” dominated headlines, and our NYT alerts kept us up until the wee hours of Friday morning, our team was also keeping an eye on:

  • ICER’s announcement of potential topics for review in 2018
  • The FTC’s testimony before the House on regulatory reform and antitrust concerns in the pharmaceutical industry
  • The Government Accountability Office’s examination into whether HHS violated the rules against “grassroots lobbying” and “covert propaganda” by producing videos supporting ACA repeal
  • Sustainable Rx’s newest campaign against drug makers

Whew! It was quite the week, and that’s just the beginning. Sit back, relax and join us as we remember The Week That Was.


The Annals of Surgery was forced to retract an article that used male-only pronouns to refer to surgeons. The paper, a recent presidential address of the European Surgical Association, received backlash from readers, who took issue with the paper’s inherent suggestion that all surgeons are men. Editor of the journal, Keith D. Lillemoe, explained that the mistake occurred as the paper was translated from its original Polish (a language in which “his” is not gender-specific). Issuing an apology to ESA leadership and on social media, Lillemoe noted that the article had been reviewed by an editor and two peer-reviewers, but that “[i]t’s my responsibility, since it’s published in the journal.”


This story is a reminder of just how critical it is to review materials with a thoughtful eye; not just for spelling or grammar errors, but for nuances that can influence the meaning of the overall piece. That goes double for pieces that are translated or may be shared cross-culturally. In our experience, we find that bringing in “fresh eyes” to review a project at the very end is crucial to catching missteps in tone and meaning. Looking at it from an outsider’s perspective ensures that the meaning of the piece is not easily misinterpreted. And for projects with a more permanent nature, like corporate narratives or value statements, we recommend message testing with your primary audiences, including employees abroad, to ensure that the intended message comes across loud and clear.


Televisions, smartphones and biosimilars? The latest entrant into the world of U.S. pharmaceuticals is South Korea’s Samsung Bioepsis Co., joint venture between Biogen and Samsung BioLogics. Yes, this is the same Samsung that has been making household electronics and appliances for decades. Using Merck’s U.S. sales team, Samsung launched a biosimilar this week for the treatment of rheumatoid arthritis and other related conditions at a 35 percent discount to Johnson & Johnson’s Remicade. Executives saw the anticipated $223 billion market (by 2021) for biological medicines as having potential for significant growth, and are determined to become a leader in the space.


With populist indignation about drug costs unwavering, non-traditional players may see this as a prime time to try to disruption the market. Samsung, however, isn’t the first “non-pharmaco” to venture into the industry; several other companies have developed biosimilars or served as contract manufacturers, including Fujifilm. With ex-US regulations supporting growth of biopharmaceutical businesses and heightened focus on drug costs, we can expect to see more industry outsiders making their mark on healthcare. What does that mean for pharmacos? For some time, stakeholders have struggled to understand innovation relative to pharmaceuticals as compared to other consumer products. Now, with technology companies moonlighting as drug makers, scrutiny over pharma R&D will only increase, as will comparisons to how competition drives down prices in technology, particularly consumer electronics.


This is not your father’s FDA. The once-staid agency is taking a more proactive approach to its mission, particularly with respect to public health. Just this week, the FDA announced it wants to reduce nicotine in cigarettes to non-addictive levels and that it is widening the scope of its work to stem the opioid epidemic by limiting numbers of individuals exposed to opioids in the first place.

When taking office, Commissioner Scott Gottlieb said that he would prioritize the opioid epidemic—and he has. In the last two months, the agency requested removal of one pain medicine from the market because of abuse issues and called a public workshop to review how best to evaluate risk/benefit profiles of abuse deterrent opioids. Gottlieb will meet with insurers to discuss opioid dispensing in September, a bold step for an agency with no regulatory authority over payers.


Gottlieb recognizes that sensitivity of opioid abuse has moved beyond media profiles to impact the votes of pharmaco shareholders, prompt Senate investigations, and raise concerns about slowing the economy. Manufacturers of potentially addictive medicines (opioid or otherwise) must recognize this heightened attention from various stakeholders, engage them early (pre-commercialization) and prepare simple, straightforward messages that address patient and prescriber concerns. Communicate these messages often with federal, state, and local policymakers, too. Manufacturers recognize that medicines are made for people who need them—and must be used responsibly. Make sure the public understands that, too.

Until next week,

 The Reputation & Risk Management Practice @inVentiv Health Communications

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