While 2018 may be considered the year of the woman, 2019 may be the year of the nonbinary. Merriam Webster named “they” -- a gender neutral pronoun some use in place of “he” or “she” – as its word of the year.

The dictionary company says searches for “they” jumped 313% in 2019 compared to the prior year. We’ve been noticing it popping up more in our life as well – with conference organizers requesting pronoun identification as part of their submissions and Broadway shows listing pronouns next to actors’ names in playbills.

We predict gender identity focused diversity and inclusion trainings will be heading our way in the future. For now, though, on to the news…



A man who changed the face of fundraising and modernizing how charities can tap into social media with viral content, passed away this week. Pete Frates, the former athlete who melted ice and hearts through the Ice Bucket Challenge died Monday at age 34. Pete’s efforts raised a record $220 million for ALS research and charities around the world have been trying to replicate his success for their causes


A subcommittee hearing in the US House of Representatives revealed the number of inspections of foreign drug manufacturers has been dropping over the last few years. The committee also discussed how the inspections the FDA does abroad are often announced 12 weeks beforehand (vs. the unannounced inspections done in the US). Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research told the committee the FDA doesn't have enough staff, but they have “developed a risk-based approach to surveillance inspections that ensures equal treatment of foreign and domestic facilities.”


The new USMCA trade agreement that has support from Democrats and the President will strip away market exclusivity protections for biologics that were included in the original proposal. Without the protections, biologics manufacturers are looking at 8 years of exclusivity in Canada, and as few as 5 years in Mexico, before biosimilars are allowed to enter the market. That’s in contrast to the 10 years of competition protection in the prior iteration. PhRMA says the agreement “puts politics over patients.” 


It’s official. Dr. Stephen Hahn, an oncologist and top official at MD Anderson Cancer Center, is the new FDA Commissioner. Experts surveyed by Washington Post say Hahn should focus on teenage use of vaping, regulation of CBD-containing products, and handling the Trump Administration’s proposal to import cheaper drugs from Canada. 


The US Patent Office pulled a lawyer off a high profile patent case regarding an HIV medicine because of some comments she made on Twitter. The lawyer, who has been with the patent office for 14 years, made contentious remarks about the activists challenging the patent. A reminder to all of us: be careful what you post!

Pulse on Policy  

By Michelle Leeds

On Thursday, the US House of Representatives passed H.R. 3, the Lower Drug Costs Now Act, a sweeping bill designed to lower drug prices. There is almost no chance the Senate will bring it up for a vote, but the bill represents an aggressive position on drug prices that Democrats will use as a key campaign message in the 2020 election.

The bill, championed by Speaker Nancy Pelosi, aims to reduce drug prices through several policies opposed by the pharmaceutical industry, including:  

  • Medicare negotiation: the bill would enable the federal government to directly negotiate the prices of the most costly 250 drugs covered by Medicare every year. It would also allow private insurers to buy drugs at the price negotiated for Medicare. Drug manufacturers that refuse to negotiate prices with Medicare would be penalized with fines of 65-95% of a drug's gross sales. 
  • International reference pricing: the bill would cap payments for drugs in the U.S. at 120% of the average prices paid in Germany, Japan, Canada, France, the UK and Australia. 
  • Inflation caps: the bill would prohibit price increases for drugs covered by Medicare Parts B and D beyond the rate of inflation, requiring companies to either roll back price increases taken since 2016 or rebate the difference to the U.S. Treasury. 

According to the Congressional Budget Office, the bill is estimated to save approximately $450 billion over 10 years. The CBO also acknowledges the flip side of these savings, which would be a decline in pharma industry revenue that could lead to eight fewer drugs coming to market in the next 10 years and 30 fewer drugs in the following decade.

The Senate is working on a less aggressive drug pricing bill, but the fate of that bill is uncertain.

What this means for life sciences companies:

Although H.R. 3 has little chance of becoming law this year, it is almost certain to be a key talking point for Democrats on the campaign trail next year. Expect this topic to stay hot in media coverage of the elections, and potentially beyond, if Congress returns to the issue for legislative action in 2021. Life sciences companies should be prepared to respond to media inquiries about how this bill and similar policies may impact their currently marketed medicines and pipeline. 

CAR-T Cost Offsets 

By Rose Shelley

CAR-T therapies were a hot hot hot topic at the 61st American Society of Hematology (ASH) annual meeting last weekend.

It’s no secret that some hospitals have been struggling to pay for treating patients with CAR-Ts, because of insufficient reimbursement relative to the care required to administer them. In fact, a study in Journal of Clinical Oncology published in November found hospitals may be losing upwards of $300,000 for each CAR-T administered, which in some cases is nearly the entire list price of the therapy!  This has led to questions about the price and uptake of CAR-Ts -- and whether they can yield the value investors hoped.

But to the skeptics, a real world evidence study presented at ASH argued that CAR-Ts may be more cost effective than people assumed. The study evaluated Medicare patients with non-Hodgkin's lymphoma who received CAR-T therapy and compared healthcare utilization, costs, and outcomes pre- and post-CAR T therapy. It found treating these patients with CAR-Ts may reduce overall healthcare costs by 27%. Treatment with CAR-Ts was associated with fewer hospitalizations, emergency department visits -- and lower total healthcare costs.

And, in exciting news, the patients analyzed seemed to show better survival rates despite being older and sicker.

Our Take

Will this study unleash better reimbursement and uptake for CAR-Ts tomorrow? Probably not. However, as developers, manufacturers and providers learn how to optimize CAR-T delivery and dosing – this study shows a promising view of how the outcomes and costs solidly justify these therapies’ value. And, increasing data showing good value may support more patients receiving CAR-Ts in earlier lines of therapy – versus coverage being relegated to only more advanced cases.

Who wrote this? The managing editor of TWTW is Randi Kahn, who is excited to breakout her light up “ugly” Chanukkah sweater for a party this weekend. ‘Tis the Season! Syneos Health Communications' Reputation & Risk Management Practice is a team of healthcare communications consultants, policy-shapers and crisis response specialists. We provide unique solutions to the evolving communications challenges in today’s healthcare industry, using evidence-based approaches to help our clients successfully navigate the most sensitive of situations.

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Image credits: ice bucket by Template from the Noun Project, Magnifying Glass by Evgeniy Kozachenko from the Noun Project, North America by Nikita Kozin from the Noun Project Take With Food by Gray from the Noun Project, Tweet by Vladimir Belochkin from the Noun Project, Congress by MRFA from the Noun Project, transfusion by LAFS from the Noun Project
And now please enjoy this disclaimer that prevents our team from getting in a heap of trouble: This report may contain links to external or third party websites. These links are provided solely for your convenience. Links taken to other sites are done so at your own risk and Syneos Health accepts no liability for any linked sites or their content. Syneos Health makes no warranties or representations, express or implied about such linked websites, the third parties they are owned and operated by, the information contained on them or the suitability or quality of any of their products or services. Syneos Health does not authorize the infringement of any intellectual property rights contained in material offered through these linked sites. Please refer to the use agreement and/or copyright statements of any external site you visit, or the terms and conditions of any externally provided web site for instructions, restrictions, and guidelines. If you have a question, please contact the webmaster of the external site.

About the Author:

Randi Kahn is a Senior Media & Content Director in our Reputation & Risk Management Practice, where she helps clients build and protect their brand reputations through executive thought leadership, public affairs, and issues preparation and response. She has worked for clients throughout the healthcare ecosystem including payers, providers, patient groups and pharma.