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.
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?
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.
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.
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.
Takeda has joined the ranks of increasingly price-conscious pharmaceutical companies that have pledged to keep their drug price hikes to “reasonable” levels in the coming year (see: Allergan, AbbVie, Novo Nordisk).The Japanese-based company recently announced it would maintain single-digit price increases, and added that its pricing model has been fair for years. However, it’s probably safe to assume that the announcement has something to do with Trump’s not-so-subtle cease and desist alarms to pharma about their rising drug prices. Certainly a push for drastic measures, but consider: in the wake of a sudden call for price lowering also comes a federal push to decrease pharma regulations, cut taxes, and speed up approval timelines for drug products. Looks like industry gods taketh away, then giveth right back.
Election season has passed and Donald Trump is set to take office in 2017, accompanied by a newly Republican-filled Congress. This means we could be poised to witness even more of the mega-mergers that have taken place across the pharma landscape. These mergers have been popular for US companies partly because it has allowed them to achieve huge (…yuge) tax savings due to US tax rates. President-elect Trump has stated multiple times that corporate tax rates are too high and that he will be working to drop them drastically to promote competition within the US. If this comes to fruition, be prepared to see more companies bring in off-shore dollars to take advantage of these changes.