Let’s make it official

Remember when Michael Scott declared bankruptcy, only to learn that just shouting the word “bankruptcy” doesn’t make it official? That’s what people are telling President Trump right about now about his August “declaration” that the U.S. opioid crises is a national emergency. More than 2 months later this is yet to be made official. This writer has no idea how easy or difficult it is to make an official emergency declaration, but time is of the essence. According to the Centers for Disease Control (CDC), 33,000 Americans die each year—91 per day—from opioid overdoses. For context, about 41,000 American soldiers were KIA in all the years of the Vietnam War. Sure, POTUS has some big fish to fry but it’s probably time to jump on some paperwork.

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Man, you fractured the council

Last week, Merck CEO Kenneth Frazier was among the first of many business leaders who left the White House’s American Manufacturing Council. The manufacturing heads cited President Trump’s comments following the protests and violence in Charlottesville, VA as the reason for their departure… and it snowballed from there with more CEOs resigning until Trump just dissolved it. Frazier’s presence on the council demonstrated the importance of drug manufacturing to the larger US manufacturing economy, and some lauded him for generating Positive Pharma Press™ by giving up his seat at that table. What’s Frazier up to next? Well according to the president, “Now that Ken Frazier of Merck Pharma has resigned from President’s Manufacturing Council, he will have more time to LOWER RIPOFF DRUG PRICES!” Ouch, Mr. President.

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Trump: opioids a yuuuuge problem

Just days after declaring his administration would throw law enforcement resources at the opioid crisis, The Donald referred to the crisis as a national emergency. According to an article by NPR, that stops juuuust a bit short of an official declaration of emergency status, which would carry with it access to specific legal authorities and access to government coffers for a more wide-spread, wholistic approach to dealing with the crisis. The President has indicated the official designation is forthcoming. This is significant. National emergency status has historically been used for things like natural disasters (i.e., hurricanes) and communicable diseases (i.e., the Zika virus). Here’s a list of declared U.S. public health emergencies. Once official, expect states like Ohio and New Hampshire—among the hardest hit—to seek federal funds for help.

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Drug prices. Wait, don’t skip this article!

U.S. President Trump has drafted an executive order on the topic of drug prices. The pharma industry is probably pleasantly surprised and pharma critics are probably confused and angry. What? They don’t agree? Crazy, right? According to the NY Times, the administration looks to be taking an indirect route to lowering drug costs by easing regulations on the drug industry with the expectation that lower costs to drug makers will translate to lower drug costs. In other words, all that “getting away with murder” stuff has softened considerably, at least as it relates to this executive order. InsightCity is taking a bold wait-and-see approach as to whether this is the end of Trump’s pharma crack-down. “Crack-down” doesn’t feel like quite the right word, does it?

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Healthcare is complicated

A recent NY Times op-ed piece and a corresponding Letter to the Editor talk about how importing generic drugs might lower healthcare costs in the US and stop what the op-ed writer perceives as price gouging. The op-ed position: just do it. The letter to the editor position: not so fast. Relationship status: it’s complicated. There are obvious concerns about drug safety and the US is making strides in protecting the drug supply with its track and trace efforts. That said, the letter to the editor proposed an interesting idea: “…speedily approve any sound generic drug application from a nonprofit entity for a drug whose price has risen sharply.” That’s one idea, but why just from nonprofits? Come on, people. More ideas required! Have an opinion on this? Participate in this week’s FastPoll™ below.

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Proposed US budget to cut NIH, raise FDA user fees

Well, President Trump… hey, where are you going? Don’t go yet! The President released his 2018 budget proposal. (We have saved you others’ analyses. This is the source document). Along with many other departments, the NIH may find itself wondering where 20% of its money went (go to p. 22 of the document). Also, prices are going up at the FDA. Plan on submitting a drug for approval? That might cost you double next year. InsightCity recommends you spend a few minutes in this document. It’s surprisingly readable. Also, the President and Congress have until October to come to an agreement so there’s little chance the proposal survives intact. There’s probably a better chance that the government shuts down or that pigs fly.

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1. Trump, Pharma, and the FDA walk into a bar…

Stop me if you’ve heard this one before. As the US waits to see who President Trump will select as the next FDA commissioner, there seems to be a push-me, pull-me between faster approval timelines and the rigorous, gold-standard process the FDA has had in place since 1962 (think thalidomide). On the surface, faster drug approvals should benefit the pharma industry, right? But what happens if long-term distrust of new medicines grows because faster approval times lead to ineffective or unsafe products? Wall Street hates uncertainty and the past few months have not been kind to pharma. See this chart for proof. So, buckle up and hold on.

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