WOOOOW!!! So, a lot happened in Washington this week…
…which we won’t be commenting on! However, in case you missed it…plenty was happening in healthcare. Here are a few news nuggets of interest:
- Francis Collins can’t be punked. The mild-mannered head of the NIH knew something was awry when the anchor of a supposed Showtime documentary asked: “why big agriculture was putting chemicals in foods to change peoples’ genders?” The interviewer was, in fact, comedian Sacha Baron Cohen, posing as a conspiracy-theorizing pundit. In his latest endeavors, Baron Cohen has been attempting to dupe officials into compromising positions – one state representative even pulled down his pants. But Collins, a consummate professional, didn’t take the bait and spent the interview educating the comedian about public health.
- Is the price right for Beijing? Landmark immunotherapy Opdivo is reportedly launching in China at about half the U.S. list price. Timing is everything as the therapy will be introduced just as “Dying to Survive,” a local movie, has ignited the Chinese populace about the price of prescription drugs, which can bear heavy patient out-of-pocket expenses after government insurance. Beijing regulators called leading pharmaceuticals to talk about drug pricing, but time will tell how the world’s 2nd largest pharmaceutical market will handle drug pricing.
- Birth control goes au naturel. The FDA approved an app for birth control. Natural Cycles claims to increase “fertility awareness” by taking a woman’s temperature and telling her when she is ovulating. We thought mandatory viewings of the Miracle of Life in high school gym class were enough to indelibly (and awkwardly) increase fertility awareness, but now there’s an app for that too.
- EpiPen expiration extended: It’s back to school, but many parents are worried about their child with severe allergies having access to an epinephrine auto-injector, which is in short supply due to manufacturing issues. In an attempt to offset shortages, the FDA extended the expiration date for certain lots of EpiPen (by a few months). Earlier this month, the agency approved Teva’s generic form of the injection in a move to increase generic competition and lower costs.
Similar to Rihanna we like to “work, work, work, work,” BUT, we’re gonna embrace the spirit of Labor Day and REST. See you in September. And now, The Week That Was
►GOV'T TO DRUGMAKERS: BULK UP YOUR STASH
The British government sent a letter to leading biopharmaceutical companies asking them to hold an additional six weeks of inventory for prescription medicines. The deadline for compliance is March 2019, in preparation for a potential “no-deal BREXIT.” A “no-deal” scenario assumes that the UK will not have worked out clear relationships and trade policy with its European Union neighbors and Brussels. In such as circumstance, normal services, and business functions could slow or come to a halt, sparking many to fear drug shortages. A spokesperson for the UK biotech industry said bulking up supplies with just 200 days’ notice will be a “massive challenge.”
Readers may recall from a prior TWTW, that the UK government has said it will recognize medical products licensed and tested by the EU. However, this is no panacea to a potential drug crisis. The whole pharmaceutical manufacturing process operates as an integrated system across Europe and the globe. Re-building such a system in the UK could compromise the quality of drug stocks with the increased risk of minor changes in temperature and/or longer shipping times. Word to the wise: drug-makers should start communicating with pharmacists, treaters, and patients now to prepare for scenarios in which some medicines may be backlogged or rationed.
►BLUEPRINT, VOLUME 2
No, this is not your favorite JAY-Z album. HHS Secretary Alex Azar delivered an update/early victory lap timed to the first 100 days of the Administration’s plan to curb rising drug prices (also known as the Blueprint). In a report issued last week, Sec. Azar reported the Blueprint is making medications more affordable for Americans, citing statistics that include:
- 15 drug companies have reduced list prices, rolled back planned price increases, or committed to price freezes for the rest of 2018.
- The Administration is increasing competition to bring down drug prices, including a whopping 128 generic medicines approved in July alone.
- Improving price-negotiating tools for government payers, including the approval of a first-of-its-kind waiver for a state to negotiate pricing contracts with drug makers.
Finally, Secretary Azar’s Rose Garden recommendation to require any television drug ads to list the price is gaining steam. According to reports, HHS has delivered a draft regulation to the White House Office of Management and Budget for review and Senators Grassley (R-IO), and Alexander (R-TN) are pushing an amendment that would fund the FDA issuing a regulation to require drug pricing in ads.
Teddy Roosevelt said, “speak softly and carry a big stick.” But when it comes to drug pricing, the Trump Administration seems to have proven that “shaming loudly” can be highly effective. When the Blueprint was first delivered, Secretary Azar faced criticism that some of its most substantive proposals couldn’t be implemented without tough-to-achieve legislation or rule-making. However, last week’s report indicates that the power of rhetoric is palpable. Executives fear landing in the crosshairs of Presidential Tweets, which have the power to move stock and drain company resources. The true test will come next January when routine annual price increases come due.
When it comes to listing drug pricing in ads, the question is “the price for whom?” With discounts, rebates, co-pay assistance and several other factors going into the pricing mix, standardizing a price in and of itself is a major hurdle. Disclosing a price that doesn’t apply to all could defeat the purpose of creating more transparency and create confusion around an already poorly understood topic. But with 70 days until mid-terms, make no mistake; this topic will not go away.
See you in two weeks,
- The Reputation & Risk Management Practice@ Syneos Health Communications