Although this weekend marks April Fools’ Day, our stories this week are no joke. The potent combination of Twitter and spandex nearly grounded United Airlines. Senate Dems jumped back into the healthcare debate with new legislation related to drug pricing, and Arizona became the first state to sanction off-label promotion of drugs as a matter of free speech. We expect backers of this law to take the model legislation to other states .
And a bonus! Our very own expert Paul Tyahla published a great piece on how innovation, access to information, and the law are driving greater attention to Expanded Access Programs and compassionate use. His guidance on how companies can communicate effectively, and compassionately, is available on PM360 online
Now read on for more from The Week That Was!
Now read on for more from The Week That Was!
OFF-LABEL NOW LEGAL, mAYBE.
Compliance folks cover your ears. Arizona just became the first state to pass legislation allowing pharmaceutical companies to promote their medicines for “off-label” use. Essentially, the law potentially allows medicines companies to promote a medicine for a different disease or dosage than what is specified in its FDA-approved label. The Free Speech in Medicine Act (HB 2382), was the handiwork of the Goldwater Institute, a Phoenix-based think tank whose past work includes being the most visible organization supporting the Right to Try movement. The “off-label” legislation marks a new milestone in the debate over whether off-label promotion is protected speech and if the FDA has authority to regulate that speech in its attempt to ensure patient safety.
This legislation won’t go into effect for nearly three months, and even then, some experts question whether or not it can offer drug makers protection from the FDA, which has authority granted by federal law. Nevertheless, the law will surely drive conversation about “off-label” use, a legal process that accounts for nearly 20% of all written prescriptions in the U.S. The Goldwater Institute has stated that they intend to take this “model law” to other states, and based on their record with Right to Try, we’re inclined to take them seriously. Drug makers should prepare themselves for questions about the “off-label” use of their products, and where their company stands on this new legislation.
Uncle Sam means business…but so does UNITED HEALTH
The U.S. Department of Justice is gearing up for battle against UnitedHealth Group. The DOJ recently joined whistleblower lawsuits over allegations that UnitedHealth Group has been “gaming” the Medicare Advantage system through inflated risk scores, or assessments that take into account differences in patients’ medical diagnoses and health outcomes to inform risk-adjusted payments. Specifically, DOJ alleges UnitedHealth Group has been requesting reimbursements for underpayments but failed to report that it has been overpaid despite knowledge of inflated risk scores.
If you recall, this lawsuit isn’t the first time we’ve seen claims of this nature. But, United’s response is noteworthy. Contrary to the “no comment” responses corporations often dish out to media in the midst of high-profile litigation, the company hasn’t shied away from questions that have come their way about the allegations. It vehemently denied wrongdoing, asserted compliance with program rules, and alluded to an alternative explanation for the case—the DOJ’s hope that judicial activism will “create new rules” to address existing policy issues.
There’s a time and place for everything, but the response “no comment” in the midst of an investigation is losing its relevance nearly everywhere. Why? Silence increasingly translates to presumed guilt. Providing a response doesn’t mean you have to aggressively assert your position, divulge confidential information, or put the company in jeopardy (Note, aggressive legal posturing has limited place in a press statement). Instead, effective responses to investigations can clarify areas of confusion and maintain the goodwill of the company throughout turbulent times. We suggest reaching a consensus with key internal staff (legal included) about things that you can speak to and topics that are off limits. Even if your response must be “no comment” in the immediate, companies should consider providing reporters background information that can help you build stronger relationships for future reporting.
DEMS RETAKE LEAD ON HEALTHCARE REFORM WITH DRUG PrICING BILL
You didn’t think we’d be able to go an entire week without a drug pricing story, did you? Senate Democrats led by Senator Al Franken (D- MN) reminded everyone that healthcare reform didn’t die with the tabling of the GOP’s America Health Care Act. Enter from stage left the Improving Access to Affordable Prescription Drugs Act. The bill includes a number of provisions aimed at lowering the cost of prescription drugs and improving transparency, including allowing Medicare to negotiate drug prices. If passed, the bill calls for GAO to study the impact of patient assistance programs on prescription drug pricing and expenditures, and creates incentives for generic drug competition. Oh, and it would allow the importation of “qualifying prescription drugs manufactured at FDA-inspected facilities from licensed Canadian sellers and, after two years, from OECD countries that meet standards comparable to U.S. standards.” The bill has 15 co-sponsors including Sens. Bernie Sanders (I-VT), Elizabeth Warren (D-MA), among others. Companion legislation has been introduced in the House.
Franken’s reforms run the gamut from more government intervention on pricing to encouraging more competition, perhaps an astute political move to improve the likelihood of finding common ground in a deeply divided Congress. Dems are counting on one Republican for support: President Trump, who has continued to vocalize his support for many of these reform concepts. Only time will tell if he’s willing to cross party lines to help nudge this over the goal line. In the meantime, drug makers need to increase their transparency and tell their value stories on the Hill—and among advocacy groups. We’ve said it before, but the perceived secrecy around drug pricing, combined with the complexities of insurance coverage, leave the average voter confused and pointing the finger at pharma. The best—and maybe only way—to bridge the gap between the industry and patients they are trying to serve is to better explain, in detail, the costs of innovation, the commitment to patient access, and the challenges of formulary placement. And smart pricing strategies supported by KOLs and advocates help, too, as we saw in the media response to recent approvals for Ocrevus, Dupixent, and Kisqali.
Freedom of….athleisure wear?
United Airlines started the week with a full blown crisis response situation about spandex. Yes, spandex. A firestorm of tweets broke out Sunday when two teenagers were barred from boarding a flight by a gate agent because of failure to comply with dress code requirements for employees and family members who fly for free on a standby basis. A fellow passenger recounted the situation in a string of tweets, and suddenly, United became the “anti-leggings” airline. United was quick to respond with a link to a policy that allows the right to refuse transportation for passengers who are not “properly clothed,” but failed to explain what that meant. After a barrage of responses—include a number of celebrities weighing in—United clarified that dress code issue related to “pass travelers” (a whole different policy) and general passengers (a.k.a. those paying for their own tickets, can continue to wear their spandex as they please). Unfortunately for United, the policy explanation came a little too late, and the airline spent most of the week defending itself against perceived sexism of the dress code, which seems to disproportionately target women’s attire.
Wardrobes haven’t caused so much controversy since Super Bowl XXXVIII! In today’s rapid fire environment, the timeliness of a response is just as important as the tone and its accuracy. For many companies, Twitter presents a new challenge. While often used for proactive consumer engagement, plans to use Twitter for responding to crises are often lacking, resulting in delays in getting the right messages out in the same channel as your critics. Having an internal system in place before a crisis situation strikes will help ensure accuracy, sound tone, and quick timing when you’re in the midst of what can seem like utter chaos. If you aren’t prepared for a situation (it happens to the best of us), acknowledge that you’re looking into an issue and promise to have a response as soon as possible. Then, follow your system to guide you through the turbulence.
Until next week,
– The Issues Management Practice @inVentiv Health PR