With Tribeca now behind us, film buffs and the elite brought their high fashion and celebrity to Cannes this week. The biggest hype was around the debut of the Elton John biopic “Rocketman,” leaving us kicking ourselves once again for missing that farewell show at Madison Square Garden in March (seriously, the videos from it were epic).

Discussion of the movie led to an interesting debate among The Week That Was team about which musical icon Hollywood should turn to next for inspiration (in addition to plans for a team karaoke outing). The responses: 

  • Olivia Rothseid: “Beyoncé. Always Beyoncé. (Granted she would need to play herself so it would be like Dreamgirls part 2)”
  • Michele Melson: “Alanis Morrisette. The story of having one epic album and then putting out several others that were not very successful.”
  • Miriam Kalnicki: “Madonna. Because who doesn’t love Madonna?”
  • Sara Fallon: “Lady Gaga. Afterall, she’s the next Madonna.”
  • Michelle Leeds: “Prince. With his death a few years ago, “Purple Rain” needs an update.”

As a born and bred Long Islander, my vote is for Billy Joel.

For now, we’ll just celebrate “How wonderful life is while you're in the world” and move on to the news.



Policymakers often talk about how increasing access to generics may help lower healthcare costs. But is that always the case? More than 40 states filed a lawsuit against leading generics companies and 15 of their executives alleging they conspired to inflate and manipulate prices of more than 100 drugs. The list includes therapies for diabetes, cancer, arthritis and several other medical conditions. Stocks for generics makers have taken a downturn upon the news.  


For years, some docs have been wary of antibiotic use, as antibiotic resistant infections are on the rise. A new study in the Lancet, however, suggests that prophylactic antibiotics could be beneficial for certain individuals – specifically women who deliver their babies with the assistance of forceps, vacuum or other device. The study found giving a single dose of prophylactic amoxicillin and clavulanic acid to these women cut their risk of maternal infection in half. The findings underscore the recent CDC report we discussed last week that found that half of maternal deaths in the US could be prevented.


When a group of hospitals and foundations came together last year to launch a nonprofit drug company, many wondered how that would even work. Back in February, we learned they won’t actually be developing the drugs themselves… at least initially. Now the group has announced its first products – forming a deal with a regular drug company to provide generics of two antibiotics that they say are often in short supply. Pricing will reportedly include “manufacturing costs, plus a "fair margin" for the drugmaker.”


After much activity over the past few months, the U.S. House of Representatives passed a package of healthcare bills. There was bipartisan support for the drug pricing related components aimed at increasing access to generics – penalizing branded drugmakers from withholding samples from generics manufacturers, banning pay-for-delay agreements, and limiting first-approved generic makers’ ability to stall competition. But, the final bill is likely to be a nonstarter in the Senate because of ACA-related measures that were included in the bundle. Stay tuned to The Week That Was as we continue to track action on the Hill regarding drug pricing (Spoiler: there’s a House Energy and Commerce Committee hearing next week on pricing transparency).  


Protected drug classes aren’t going anywhere. The Trump Administration announced that it won’t implement a policy that would have allowed Medicare Part D plans to exclude antidepressants, antipsychotics, anticonvulsants, immunosuppressants for treatment of transplant rejection, antiretroviral drugs (such as those used to treat HIV), and anti-cancer drugs from their formularies. The Administration had initially proposed allowing Part D plans to exclude these “protected drugs” if their price increased beyond a certain threshold or if the drug was a new formulation of an existing single-source drug or biological product. This doesn’t mean drugs in these categories will be available without any limitations; CMS does plan to implement the part of its proposal allowing Part D plans to use step edits or prior authorization, but only for new starts.


A View on Value

Reducing drug prices remains a top issue for American voters. Policymakers have hosted a variety of hearings lately as they barrel towards legislation to placate them - many often pointing fingers at specific drug companies and therapeutic classes. It’s a tough environment for drug makers, which is why communicating value has never been more important.

Now, we have a new tool in our toolbox: data on the investment in drug development over time. This week, Regulatory Focus dug into some recent IQVIA data we mentioned a few weeks ago, noting that while the number of clinical trials required for a drug to get approval has declined, the design of the clinical trials is becoming more rigorous and the duration of trials remains long. That’s especially the case for orphan drugs, where companies need to accumulate adequate safety, efficacy and durability over time data from smaller overall patient numbers. That’s in addition to comparing effectiveness to the current standard of care.

Highlights from the report: 

  • 42% of novel drugs approved in 2018 were approved on the basis of only one trial. And one out of eight approvals relied only on Phase 1 or 2 trials, with no Phase 3 trials. As in previous years, a large portion of the drugs relying on only one trial were new orphan and cancer drugs.
  • Nearly 90% of drugs included randomized clinical trials in their regulatory packages.
  • Nearly half of the new drugs (46%) were tested in trials with active control arms, versus only 20% a few years ago. This highlights the increasing importance of comparative effectiveness in disease indications where existing standards of care are in place.
  • The cumulative years in the clinic and registration remains long at 12+ years. This average time holds true for both orphan drugs and non-orphans, interestingly.
  • The average trial duration for orphan drugs is 12% longer than for non-orphans, based on the 4-year averages (7.6 years vs 6.7 years).

Our Take:

The nuances of development often get buried in conversations about a drug’s value. As pricing continues to be under the microscope, it is important to be upfront about everything that went into a drug’s development, including the details about how your trials were conducted, and how they’re unique. Greater understanding about the process, in addition to the impact a drug will make for patients and caregivers, is a key to acceptance. While we cannot darken the spotlight instantaneously, increasing transparency about what exactly goes into R&D could move us in the right direction.

Who wrote this? The managing editors of TWTW are Randi Kahn, who is happy she at least got to see the Who’s farewell tour, and Dana Davis, who is at a college graduation this weekend (not her own). 

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: Justice Scale by Vectors Market from the Noun Project,  pregnant woman by Alice Noir from the Noun Project

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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.