2019 went by fast, but when looking back, so much happened! There were 48 new drug approvals, three FDA Commissioners (one “acting”), the launch of the first $2+ million therapy, and the New York Stock Exchange ARCA Biotechnology Index was up around 20+%. Oh, and our practice nearly doubled in size – strengthening our capabilities in public affairs, advocacy relations, risk mitigation and financial communications.

As our last issue of the year, and in keeping with The Week That Was tradition, we’ve broken down some of the biggest stories of the year impacting the healthcare industry. There’s something for everyone complete with a few predictions for 2020.

Thank you for your loyal readership and we look forward to working with you in the new year! 

The Year in Pricing Policy That WASN'T

The year in drug pricing policy was peppered with hearings, notices of proposed rules, advancing legislation and plenty of campaign speeches. But come year end, very little law is actually different than when it began. A rule requiring manufacturers to include the list price of their medicines in TV ads spurred voluntary action by some companies, but was ultimately struck down by a federal judge. Meanwhile, the International Pricing Index, first floated by the Administration in 2017, still hasn’t been formally introduced, and a sweeping bill that would empower the government to directly negotiate drug prices with manufacturers appears destined to change or fail in the Senate. There was some action affecting the marketplace, such as the largest number of generic approvals in history. But that more or less continues a trajectory in place for several years.

It may have felt like there was an increase of rhetoric about drug pricing in 2019, but this year was not all that different from the previous few. The cycle of political commentary began roughly when presidential candidate Hillary Clinton tweeted about “price gouging” in the specialty drug market, and announced a plan to address it. That was in September 2015.


So, will 2020 be different? Perhaps. While Washington remains deeply divided, there is still momentum behind many of the rules and legislation that were introduced, but not finalized in 2019. Among all voters, lowering drug prices continues to be among the most popular ideas – at least conceptually. The industry certainly avoided major structural changes this year, but advocates only have to be successful once to have a long-lasting impact. And there’s the election cycle to consider. Both sides are looking for an accomplishment to tout on the campaign trail, bringing more motivation to take action. Stay tuned!


 Is Vaping Going up in Smoke?

Few days passed in 2019 without some news regarding e-cigarettes, vaping, juuling or whatever you may call it. The vaping industry, once touted as the “healthier alternative to cigarette smoking,” is facing regulatory, legal and public health pressures following CDC reports of 2,506 people in the US being hospitalized with associated lung injuries -- and 54 succumbing to those injuries.

An industry once touted as the future growth of big tobacco has come under pressure – but will it, too, go up in smoke?

In response to the widespread spate of lung injuries, efforts focused on youth intervention escalated. A National Institute on Drug Abuse survey revealed a quarter of high school seniors and sophomores had vaped nicotine within the last month. The number of teens vaping marijuana also surged. The FDA's Youth Tobacco Prevention Plan launched its first e-cigarette prevention ads to kids last summer on TV, social media and in high schools. The Trump Administration flirted with banning flavored e-cigarette products, before backtracking.

State lawmakers took actions into their own hands. Michigan, New York and Rhode Island attempted to enact bans on flavored vaping products, but their efforts stalled in the courts. Massachusetts recently announced the strictest statewide regulation: a four-month halt to sales of all vaping products.


What’s next for vaping? By May 2020, e-cigarette makers must submit applications to the federal government to keep their products on the market. The new FDA Commissioner, Stephen Hahn, sidestepped questions about his plans for vaping at his confirmation hearings, so the idea of a federal flavor ban is still hazy. However, some manufacturers, such as Juul, seek to proactively avoid regulation by pulling popular flavored pods off the market because of their appeal to teens.

While the “heat” and regulatory pressures are increasing for vaping products here in the U.S., watch the international markets where vaping companies are likely to go next for new populations and revenues. Also, expect the vaping industry’s next line of defense to focus on banning the use of illicit products in e-cigarettes. Early reports seem to suggest that the vaping lung injuries observed in the States are related to use of cannabis and THC laced products – and not the manufacturer’s pods.


Opioid Litigation Optics Hurting the Pharma Industry

Anyone observing any form of news over the past 12 months can agree that opioids, and in turn, opioid trials, were at the top of the public consciousness. The first state lawsuit to make it to trial in Oklahoma resulted in a $572 million verdict, later reduced to $465 million. Weeks later, the same defendants in that trial settled with two Ohio counties in a bellwether federal case that is speculated to pave the way for a much larger (and as-yet unreached) global settlement. What do all these cases mean for the public perception of pharma?

As opioid manufacturers, distributors and sellers faced the court of law, they also found themselves on trial in the court of public opinion. Stories about the detrimental effects of the opioid crisis on towns across America shaped opinions across the country, while politicians and policymakers excoriated pharma for its purported role in the epidemic. Nine-figure verdicts and settlements, heavily covered in all manner of media, further cemented this in the public’s mind. Unsurprisingly, pharma’s reputation sunk to an all-time low among industries in a Gallup assessment, which attributed at least part of the unfavorable ranking to the opioid crisis.


Opioid litigation won’t end soon and pharmaceutical manufacturers will continue fighting an uphill battle against negative public sentiment. Upcoming trials, including a New York state case set for January and another federal trial scheduled for October, are likely to generate additional unfavorable publicity for pharma companies. According to Gallup’s analysis, perception of the industry may not recover until the opioid crisis, and pharma’s role therein, is closed.

Pharma companies looking to buttress their reputations against waves of litigation and negative news need to begin communicating contriteness and the impact of proactive programs to remedy wrongs. The billions of manufacturer and distributor dollars going into settlements will benefit anti-addiction funding at both the state and county levels. As the settlements begin paying out, manufacturers must focus on evolving the story to highlight efforts to ameliorate the problem and responsibly steward less addictive pain management therapies.   


Slow Start, Strong Finish: A Look Back at Biotech IPOs 

With evolving healthcare and economic policies, investors were more selective and conservative with placing their bets on the healthcare industry in 2019. The healthcare IPO market appeared to be flat relative to 2018. And, when drilling down to the biotech/pharma sector, IPO raises actually shrunk from 63 companies raising a total of $8 billion in 2018 -- to 50 companies raising $5.3 billion in 2019. So, why the pullback from investors -- and is there hope that 2020 will be a stronger year for public offerings?

2019’s Bumpy Ride

A scan of the New York Stock Exchange ARCA Biotechnology Index (BTK) reveals that the industry experienced extreme undulations this year, which may have impacted investor sentiment. 2019 started slow for IPOs with 10 biopharmas going public in the first quarter. This skittishness may have been influenced by the 2018 end-of-year sell-off and the U.S. government shutdown in January. But the second quarter brought in some sunshine with 18 biopharma IPOs. The third and fourth quarter were even stronger with 22 companies going public -- over half of those offerings incurring in October.

When you parse the 2019 data, there was no clear correlation between the size of the raise, the time of year, the lead manager or the return performance. The largest IPO of 2019 came from Genmab (raising >$500M) followed by BridgeBio ($349M) and Gossamer ($276M). Despite the truculent environment, the 2019 IPO graduating class provided a strong return with an average of 29% versus 23% in 2018. Investment bankers and company management teams had to work judiciously to time the market and investor sentiment for a successful offering, not an easy task!  


2020 may hit a tipping point where environmental factors may influence receptivity to IPO investments. Indubitably, there are attractive private companies that may fill the IPO calendar next year, including this list from FierceBio. But the anticipated election year scrutiny will likely impact the industry’s performance and increased M&A activity may lead to companies being acquired before they can go public. While these trends may lower the total number of IPO offerings, there is potential for higher valuations. Net/net: The IPO market might be a little more challenging next year for companies and investors alike. However, we believe well run companies, with strong management teams and great science will always attract investors.

Who wrote this? The managing editor of TWTW is Randi Kahn, who is planning a reboot for 2020. Stay tuned! 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: American Flag by Xinh Studio from the Noun Project, juul by Jake Tubbesing, Bull Market by Icon Island from the Noun Project

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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.