Happy Monday readers! We’ve got a busy week behind us and another underway so let’s get to it.

  • The FDA was all business this week. They encouraged development of devices for pain and addiction, and issued new draft guidance to curb exploitation of the REMS program by drug makers seeking to delay generic development. Oh, and they approved the first stand-alone prosthetic iris.  
  • Arkansas became the first state to test a work requirement for non-disabled Medicaid beneficiaries. The pilot will support eligible beneficiaries in finding opportunities, but if they fail to comply, they can be locked out of coverage for the year. The impact will be big—for both Medicaid recipients and pharma companies with significant Medicaid populations.
  • PhRMA checks ICER, funding a new analysis showing that reliance on value assessments may limit access to life-saving medicines for Medicare Part B beneficiaries.
  • And hot off the press of the monthly A.P. style update alerts (yes, we read those): a ruling to maintain the two-word viability of “health care.”

The R&RM team will be on the ground at BIO in Boston this week. Our Practice lead, Meg Alexander will be moderating a panel about value and access. And our colleague, Peter Pitts, will join a panel about pain therapy developments. If you’ll be there, drop us a note and we’ll share the details.


Anyone else hear Trump mumble “Right to Try is happening” before he gave his speech on the Blueprint a few weeks ago? Well, if you did, you weren’t dreaming. It was a sneak peek to this week’s signing of Right to Try, the capstone of a decade-long effort by conservative political organizations and patient advocates to broaden access to investigational medicines. The new law seeks to lessen the FDA’s role in patient requests for access. Specifically, it will eliminate the need for the FDA’s Institutional Review Board to approve requests and prohibit the Agency from considering adverse events in eligible patients when reviewing a drug for approval (in most cases). The law will apply to patients with life-threatening diseases who have exhausted all approved therapy options and are ineligible for relevant clinical trials.


The law is really a slightly more expedited regulatory pathway for a subset of patients. The bill does not automatically grant patients the right to access investigational medicines from developers, but it kind of makes it sound that way. That potential confusion—and the fact that saying “no” to ineligible patients will be the burden of drug makers alone—increases PR risk for companies. Now, more than ever, companies need to be clear about their expanded access policies and prepared for activism campaigns on behalf of patients seeking “right to try.” Feeling underprepared? Let’s chat.


Pressure on companies to act on social issues isn’t going anywhere anytime soon. Following an April incident in a Philadelphia store, Starbucks last week closed 8,000 North America locations to undergo a racial sensitivity training with 175,000 staff members. And drug maker Sanofi became unexpectedly involved in the Rosanne Barr tweet scandal, after Barr blamed her remarks on Ambien. Sanofi responded on Twitter:


Starbucks and Sanofi are just the latest reminders that in our current environment, companies can become entangled in a social or politically charged issue in mere seconds. All it takes is someone to fire off a tweet, snap a quick video or draft up a Change.org petition. What that means for communications teams is that preparedness is an absolute must.

A lot of healthcare companies are hesitant to even prepare for these kinds of issues because they have no intention of making even remotely political statements. We get it; it’s a minefield out there. But taking a stance on certain issues doesn’t need to feel too risky if the message aligns with well-established company values. Take it from Sanofi’s head of communications, Angela Bechan, who led the charge on drafting the reply and getting it through internal review at Sanofi: "It comes down to our core values at Sanofi: we take diversity and inclusion very seriously. It is part of how we work every day." Or here’s how Ken Frazier put it, at an event we attended this week: “It’s important for all of us to believe in fundamental issues of justice; CEOs should relate to what our society considers core issues.” As far as we’re concerned, when it comes to social value communications, Sanofi gets an A, as does Ken Frazier.


It was the “You’ve Got Mail” ping heard around the world: last Friday, GDPR, the General Data Protection Regulation, went into effect in the EU. A week later, our team has finally emerged from inboxes clogged with “Updates to Our Privacy Policy” to take you through the high points.

GDPR seeks to better protect a consumer’s data. Specifically, personal data, including:

  • Names, emails, address, ID numbers
  • Racial data, political data, sexual orientation
  • Health and genetic data.

Companies now must obtain consent from people to collect this data and give customers rights to it. Any company operating in the E.U. must be compliant with GDPR or face a serious fine.


This is a big deal for healthcare companies. Partially because it implicates data the industry is in the habit of collecting. And, because with the “data portability” qualification of GDPR, consumers can request all their data from one company and then give it to another company. So, for example, someone could request all their data from their insurance company, and then give it to Fitbit.

All of these changes will require companies be better prepared, especially when it comes to consumer communications. If a company experiences a security breach, they must let customers know within 72 hours. These disclosures are tricky (cough, Equifax). Our best advice: proactively prepare some reassuring, consumer-centric messages and run some simulations so you don’t have to build your response while you’re doing it.

Lastly, a reminder not to try to carry the whole team on your back: give your colleagues an assist and sign them up for TWTW.                                

-  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.