Regulatory Rigamarole

Happy Monday! The Week That Was team survived the 4th (and hopefully last) nor’easter of the season and is taking in the storm of news that blew in with it: 

• Congress approved a $1.3 trillion spending bill to fund the U.S. Government through September. The bill includes funding increases NIH, CDC and an additional $94M to expand FDA efforts to seize illegal opioids at international mail facilities.
• Americans think pharma has more policymaking influence than Wall Street or the NRA.
• The first patient receives new curative gene therapy treatment Luxturna, but not without a prior authorization scare.

But those are just flurries in a blizzard of news, so read on for The Week That Was...

►RIGHT TO TRY PASSES HOUSE

The House of Representatives passed a Federal “Right to Try” bill this week by a margin of 267-149, making it much more likely that a version of the proposal will become law this year. The House-passed bill is narrower than previous proposals and other state versions, but the objective is the same—to largely remove the FDA’s oversight and approval role for terminally ill patients seeking early access to experimental medicines. The proposed law does not require the makers of medicines to provide access to their investigational therapies.

►OUR TAKE

The legal impact of Right to Try on pharmaceutical companies is minimal. However, it is yet another trend that elevates the visibility of expanded access issues, and the bill title may confuse some patients into thinking they have a right to receive investigational medicines. To avoid reputational challenges, companies need policies that balance compassion with clear protocols and a system for handling sensitive conversations. Patients and advocacy groups will have varying levels of experience in requesting expanded access, and it is the pharmaco’s responsibility to be transparent and work with advocates to explain policies, risks and rationale.

►PETITIONING THE CITIZEN'S PETITION... 

A federal judge threw out a first-of-its-kind lawsuit this week in which the FTC sued ViroPharma (now owned by Shire) for abusing the citizen’s petition process to impede generic competition to a best-selling medicine. FTC’s suit alleges ViroPharma filed 46 citizen petitions to stall the entry of generic to its drug Vancocin D. The lawsuit was notable because the FTC had never before cited use of the petitions as a tactic for delaying competition. Even though the case was dismissed, the court gave the FTC the opportunity to amend and refile its suit if the agency could prove the potential for ongoing harm—a technicality that may make it harder for pharmacos to stave off similar suits in the future.

►OUR TAKE

The lawsuit was notable because it’s the first time the FTC cited use of a citizen’s petition as a challenge to generic competition. And these days, expediting competition is viewed as the key to lower drug prices—so the media and the public are paying close attention to regulatory behind-the-scenes activities to speed generics to market. As the media increasingly focuses on end-of-lifecycle business activities, pharmacos need to lean in to brand teams to create continued drumbeat of good patient stories and additional investments in access and ease-of-use. These stories inject balance and remind the public of the long history of patient benefits delivered by branded medicines.

►TOO LITTLE, TOO LATE FOR FACEBOOK APOLOGIES? 

Facebook CEO Marc Zuckerberg, the seemingly invincible wunderkind, has been taking a metaphorical beating in recent days. Facing an FTC investigation into improper sharing of data related to the 2016 election, a class action lawsuit and Congress starting to line up hearings, Zuckerberg’s company and personal stock are plummeting. While regulators and consumers were already scrutinizing and making accusations, Zuckerberg stayed silent for five days before commenting—and took another half day to say he’s “really sorry.” Hey, maybe if Mark had read TWTW’s coverage of KFC’s chicken shortage, he would have jumped on taking full page apology ads a bit sooner…

►OUR TAKE

For a social media company, Facebook sure didn’t pay heed to how quickly a business crisis can turn into a PR crisis—especially when your “customers” have a robust platform for commentary.  These days, everyone has power, whether backed by investor dollars or online followers. We counsel our clients to heed early warning signals and have escalation plans in place to respond swiftly and directly. But if you’ve reached the point of government investigations, you’ve certainly waited too long to respond.
 
Of course, this type of situation is not unique to Facebook. With the public’s distrust of pharma higher than any industry, we counsel clients to keep issues preparedness plans updated and at the ready. Our best practices include identifying and training your crisis response team and drafting protocols so your company can be ready to assess any scenario before it becomes a full-blown crisis. It’s also critical for your company’s communications team to always have a seat at the table, since they are the ones tasked with preparing and delivering your public messaging.

If you want to read a little more about our best practices, our very own Leslie Isenegger was mentioned in a PR Daily piece recapping a recent HPRMS event where she spoke on an issues preparedness panel.

Until next week,
-  The Reputation & Risk Management Practice @ Syneos Health Communications