Gooooooooooooooaaaaaaaaaaaaaaaaaaaaaaaaaal!!!!!!!!! Sorry folks, we've been feeling inspired by the World Cup kicking off and needed to get that out of systems since 2014. While the rest of the globe is focused on soccer (or football), we haven't missed last week's penalty kicks in healthcare:

POTUS Price Chopping: Taking a page from Walmart's low, low prices, officials of the Trump administration met with drug companies this week to push for "voluntary" price cuts. Using the same definition of voluntary, we're going to clean the garage, hit the gym and pre-file next year's tax return.
Put yourself on ice? That's not a joke. A startup with experts from Harvard and Stanford promise to store patients own stem cells with the hope they can treat later life diseases. But critics say, "cool it." Despite the company's roster of prominent supporters, its marketing materials tout medical benefits for conditions for which there are little promise to-date of stem-cell based treatment.

PFDD. PFDD is not the new party drug. Rather, it's the latest guidance document from the FDA detailing how patient-focused-drug-development can be improved. This represents the first of four imminent guidance documents from the FDA, and it outlines how experience data can be collected and used for medical product development and in regulatory decision making.

PABNAB = bad, bad news. In a move that embarrassed us all, the customary after after party at the annual BIO conference took a distasteful turn. PABNAB (the party at BIO, not associated with BIO) chose to entertain party-goers with scantily clad female dancers whose bodies were strategically painted with pharmaceutical sponsor logos. In an era of #metoo and questionable representation of women in biopharma leadership, the objectifying move is embarrassing – and the exact opposite culture of what the majority of life-sciences leaders seek to cultivate.
And, are you still struggling to understand what the Administration's drug pricing Blueprint does and does not mean for biopharmas? Our colleague Peter Pitts breaks it down in Morning Consult.  
But wait, there's more! Put on your pharma jersey and tighten those laces, let's run intoThe Week That Was… 

►TAKING THE ANTI OUT OF ANTIBIOTIC DEVELOPMENT FDA Commissioner Gottlieb was busy last week! On Tuesday, in prepared remarks, Dr. Gottlieb proposed a new reimbursement idea to incentivize the development of antibiotics – an area of critical need as cases of resistant microbes and fears of antibiotic resistance accelerate. His idea takes a page from the software licensing industry and suggests that hospitals should buy a "license" to use a novel antibiotic, rather than the traditional model of being reimbursed on a per use basis. The goal is to provide a predictable return on investment and revenue stream for developers of novel antibiotics as well as give hospitals more granular management over prescribing practices.

Buckle up, folks. This is a whole new FDA. Remember the days when FDA didn't weigh into drug pricing issues – well – those times are a-changin'.  Increasingly, the FDA is weighing into the drug pricing discussion, and in this case, it represents a solid move. Anti-microbial resistance is a real threat. Efforts for responsible antibiotic prescribing stewardship can help prevent the inappropriate use of antibiotics. However, less prescribing can be a disincentive for life-science companies taking a bet on novel antibiotics development, because it can mean limited commercial return. Our thought: If FDA wants more antibiotics, create a voucher program similar to those granted for tropical infectious diseases, which help incentivize innovation.

►IS CRISPR TOAST? Our biotech funds were hurtin' last week, as two studies took a slice out of CRISPR, the crown jewel of gene editing. Two studies published in Nature Medicine claimed CRISPR's approach to gene editing may trigger cancer development. At the heart of the issue is a gene called p53, known as a DNA "first aid kit." When gene p53 is altered in a cell, the call can lose the ability to police itself for faulty DNA. In fact, many cancer cells carry damaged p53 genes. However, the pressure on CRISPR stock prices was potentially worsened by the comments of CRISPR Therapeutics CEO Sam Kulkarni, who said the study results were "plausible" and needed to be carefully studied. He also noted that the cancer concerns impacts just one application of CRISPR.

The dive in CRISPR stocks was premature. There are several applications of CRISPR, and a setback in this approach does not = a death knell. But, it does indicate the level of preparedness all development CEOs should have in place. If you are innovating in a new or controversial category, odds are, there may be some setbacks. How you respond in the press can buoy or tank confidence from your investors and scientific supporters.

►LET'S TALK ABOUT VALUE, BABY. Okay, for those of you were hoping this title would preface a Salt-n-Pepa-style lyrical rendition of FDAMA 114, keep waiting. Maybe the next issue. The FDA issued two final guidance documents last week that directs how drug makers can communicate with payers, formulary committees, and pharmacy benefit managers. The guidance enables drug makers to share truthful, responsible information about investigational drugs with payers before they are approved, so long as it is clear the medicines are investigational. Additionally, manufacturers are allowed to share information with payers and communicate about approved and unapproved uses of their products that are not contained in their products' FDA-required labeling, so long as it is done in a "truthful and non-misleading way."

The guidance’s are a positive step. They provide more predictability for developers and encourage them to be more transparent in sharing information with payers sooner. Under this guidance, developers of innovative medicines can provide more confidence-sharing information with payers and enter into contracts that reward outcomes, also known as value-based contracts. Value-based contracts are good for the system, as they pay for medicines that work in the real-world – and they are good for patients as they may help expedite coverage decisions for new, game-changing medicines.

Until next week,
-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.