Summer hit the country hard this week, with temps on both coasts and most of the Midwest reaching near-triple digits. Last week’s headlines were nearly as extreme. From one biopharma’s Right-to-Try misstep to political shade thrown at BIO and PhRMA for the infamous PABNAB rager, the industry heated up with one controversy after another. Crank up the A/C and read on for The Week That Was…

  • Amazon took a couple of major steps toward healthcare disruption this week, purchasing online pharmacy PillPack for a cool $1B. The deal gives Amazon access to hundreds of millions of U.S. consumers who order six billion 30-day equivalent prescriptions every year. The acquisition comes hot on the heels of Amazon-JP Morgan-Berkshire Hathaway hiring Harvard professor and Brigham & Women’s star doc Dr. Atul Gawande to lead its headline-grabbing health venture. This time next year, we could be lighting orange fireworks in honor of the ‘United States of Amazon.’

  • Guilt by quasi-association? Washington Sen. Patty Murray took industry trades BIO and PhRMA to task for the infamous PABNAB (Party at BIO Not Associated with BIO) that included logo-painted topless dancers. In a letter, Sen. Murray’s demanded that the groups detail what they are doing to address sexual harassment at their members’ companies. In response, BIO has informed members that they will be kicked out for sponsoring the event in the future.

  • In her first in-depth report for ProPublica, former Bloomberg reporter Caroline Chen published a scathing report accusing the FDA of being too friendly to pharma. Chen contends that the agency has become lenient under the Gottlieb regime, granting expedited approvals based on questionable data. Industry voices fired back, accusing Chen of selective reporting of the facts. 


►ACCESS—EXPANDED THEN RETRACTED—IN ALS 
BrainStorm Cell Therapeutics made headlines recently by promising broad access for its investigational ALS therapy—for a price of about $300K. When BrainStorm CEO Chaim Lebovits said the “right-to-try” program was a “semi-commercial enterprise,” critics hit the company hard, calling the plan potentially dangerous, exploitive and even illegal. After days of intense scrutiny, the company cancelled the program, stating that access to the medicine would only be available through a clinical trial it is currently enrolling. Lebovits blamed a Bloomberg reporter for taking his comments about profiting out of context, causing the controversy.

►OUR TAKE
While the new Right-to-Try law has been heralded as expanding patient access, it really just removed the FDA from the petition process—causing confusion and consternation for patients and pharmacos alike. Patients, understandably, want access to potentially lifesaving therapies as soon as possible. But “right-to-try” doesn’t mean “right-to-try for free.” Drugmakers are absolutely within their rights to charge in order to recoup manufacturing and other costs associated with expanding access to investigational medicines.  Moreover, pharma companies want to protect the integrity of their clinical development programs—an issue that gets complicated by granting access outside clinical trials. And while the FDA is not supposed to factor in expanded access data as part of an NDA, Wall Street and Main Street often interpret AEs in “right-to-try” patients as safety risks, stifling uptake in the indicated population.
 
As the dust settles in the post-RTT environment, pharma companies need to be mindful of patients’ perceptions of these rights versus the letter of the law. We advise our clients to get ahead of these questions: Be fully transparent with clearly communicated policies regarding expanded access—even if that policy is no access—readily accessible to the public.  Prepare statements about the company’s rationale, should media or policymakers come calling.  And never ever try to use expanded access as a press hook. Even the best intentions around RTT will seem disingenuous if the program doesn’t pan out as promised. Too much is on the line (for both patients and pharmacos) to treat expanded access as an afterthought.

►IS TRUTH IN ADVERTISING WAC?
According to a Kaiser Family Foundation survey, 76 percent of people polled are in favor of requiring biopharmas to include list price in prescription drug ads—a notion floated by the Trump Administration in its “Blueprint to Lower Drug Prices.” KFF notes that this proposal received bipartisan support, with nearly equal numbers of Democrat, Republican and Independent participants in favor. Critics note that this effort to improve pricing transparency would be moot, since few patients don't actually pay list prices.

       

►OUR TAKE
Overwhelming support for pricing disclosures in ads reflects continued populist angst over drug prices. However, this effort toward more transparency would actually provide less—or, at the very least, be very misleading for consumers. As those in industry know, list price is just a starting point. Consider weight-based or other individualized dosing, and then factor in discounts and rebates to payers and PBMs. In reality, there isn’t just “one” price for a drug—and making it appear otherwise may just add to the confusion for patients.  How can pharmacos get ahead of this potentially distorted reality? Promote your patient support programs.  Call centers that help patients understand their health plans—whether a drug is covered and what they will likely owe out-of-pocket—provide actual transparency, albeit on an individual level.

We’re prepping the grill and mini-pool to get ready for Independence Day, but we’re giving our laptops a much-needed rest. TWTW will be on hiatus next week, but we’ll return to your inboxes on July 16th. Happy 4th!

-  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.