March made quite the entrance this year. The Week That Was team is relieved to be back online after that wicked nor’easter gusted through town, taking out power, crippling train lines and most certainly mussing our hair. While we brace for even more bad weather this week, here are a few healthcare news highlights:

  • Last Wednesday marked the 10th time Rare Disease Day was officially celebrated in the United States. The FDA recognized the event by announcing that it’s collaborating with NORD to find ways to incorporate the “patient experience into regulatory discussions.”
  • In addition to the flurries in the skies, there was also a flurry of activity around the opioid epidemic:
    • AG Jeff Sessions introduced a task force that is said to have a particular focus on opioid manufacturers and distributors;
    • A bipartisan group of senators introduced CARA 2.0, which includes $1B to fight the opioid epidemic;
    • POTUS suggested the death penalty could stop the opioid epidemic;  and
    •  An Illinois doctor is helping his patients fight their addiction with marijuana

Read on for more The Week That Was …


Some of us are old enough to remember that iconic question: “Where’s the beef?” Well, fast food customers in the UK were left asking, “Where’s the bird?” as KFC was forced to close hundreds of restaurants after running out of chicken. Yeah, that’s right—no chicken! The chain immediately issued an apology letter by taking out a full page ad in British newspapers saying: "A chicken restaurant without any chicken. It's not ideal. Huge apologies to our customers, especially those who traveled out of their way to find we were closed." This bright red ad was printed alongside a picture of an empty bucket with the chain's initials scrambled to say "FCK.”


As a rule, we don’t advise clients to use profanity in corporate communications; however, we have to give major kudos to KFC for addressing this issue quickly and with humor. Apparently, the shortage was due to a change in delivery logistics that delayed the poultry shipments. Instead of pointing the finger at the shipping company, KFC owned up to the problem and thanked their customers for “bearing with us.” The ad showed the company’s authenticity and was well received. Contrast that to some non-apology apologies (cough *United Airlines*) and see difference in customer reaction. When companies are concerned that their stakeholders may have reason to lose faith in their business or services, we advise issuing corporate communications that balance humility, transparency, and confidence—and certainly a little humor helps, too. Well done, Colonel Sanders.


News in pharma this week speculated on the power and priorities of the PTO. What’s that, you ask? If you guessed “parent-teacher organization” or “personal time off,” you’re wrong. We’re talking the U.S. Patent and Trademark Office (PTO), which recently installed a new director who can potentially have a more direct impact the number of generics on the market than the FDA. As Under Secretary of Commerce for Intellectual Property, Andrei Iancu has the power to influence how easily generics companies can challenge weak or non-innovative patents and weigh in on the types of patents that get approved in the first place. 

A former IP litigator, Iancu has said very little since being confirmed; however, many are speculating on his approach to pharma IP based on the PTO’s recent ruling against Allergan.  Last week, a PTO board ruled that the St. Regis Mohawk Tribe couldn’t claim sovereign immunity to avoid patent challenges, thwarting Allergan’s attempt to avoid inter partes review of dry eye drug Restasis by transferring patent rights to the tribe. (Mylan, Akron and Teva have requested the patent review as they prepare to launch generic competitors to Restasis.) Long-time critics of the U.S. IP system praised the decision and hope it’s a sign of things to come under Iancu, arguing that drug makers have been allowed to extend exclusivity using legal but questionable tactics.


With the FDA consistently vocal about fostering and expediting generic competition, a PTO that supports patent challenges and a potentially narrower interpretation of law could really put the squeeze on branded manufacturers. At the same time, media scrutiny on pharmaceutical lifecycle management and the introduction of authorized generics is increasing. As the public becomes more concerned that pharmacos are looking to charge as much as the market will bear, manufacturers must discuss the value of medicines over time—not just at approval. Now more than ever, companies need to evolve product value narratives to include additional research, label changes, and other investments that may result in new patents or extended exclusivity. Moreover, pharmacos must develop solid communications plans around LOE, similar to any other major product milestone. How a company messages business decisions around patent expiration/LOE is essential for maintaining stakeholder relationships and corporate reputation.

That’s it for us.  The Oscars are on and, in a very rare feat, TWTW team has somehow managed to see *most* of the nominated films.  So we’re off to root for our faves (and probably doze off on the sofa).

Until next week,

-  The Reputation & Risk Management Practice @ Syneos Health Communications

About the Author:

We are a team of healthcare communicators, policy-shapers and crisis response specialists. Drawing upon professional experiences from Congress, CMS, HHS, hospitals, and health technology—and our collective work in rare disease, oncology, diabetes, gene therapy, pain management and infectious disease—we provide unique solutions to the evolving messaging challenges in today’s healthcare industry. We support our clients with evidence-based approaches to preventing pricing pushback, protecting brands from modern activism, establishing and communicating clear policies surrounding expanded access to medicines, and a proactive approach to value frameworks. Our offerings also include product safety, litigation, regulatory risks, ex-U.S. considerations and policymaker investigations.