Pharma's future....the road ahead

I've seen lots of articles and various social media posts over the last several weeks trying to figure out exactly what the future holds for our industry (e.g. pharma and biotech) with a brand new administration settling in.  Admittedly, I'm curious as each new administration sets a slightly different course for us to follow but in general, the course never seems to veer left sharply nor right so I tend to bide my time and see exactly where each administration takes us. One thing I've learned in more than 20 years in this industry is that change doesn't come fast.  However being curious about where we might be headed in these early days of a new administration, I spent some time today while eating my lunch and read a number of articles trying to get some better insight into what our future may hold and here's what I learned. 

Lower drug prices

Drugs cost too much and this administration wants to change that. Ok, this one I completely understand. I am one of those people who has watched the price of my EpiPen® skyrocket over the course of the last several years (from approx. $200 to over $500 and no coverage by insurance). I certainly don't consider this affordable. I also know, as I'm sure many of you do, that when I switch health plans the cost I pay for routine "maintenance" medicines is not the same. Anything that can be done to help change this for the better without sacrificing the quality and safety of our medicines would be a step in the right direction.

Bring pharma manufacturing jobs back to the US

Our pharma and biotech jobs have moved overseas. While I think this one is easy to understand (we need to bring them back) but much harder to solve. I've been through one plant closure and one "reduction in workforce" at two different US based pharmaceutical manufacturing sites. I have watched countless friends loose their jobs as manufacturing moved overseas and been forced to find a new job at a timing not of their choosing. In principle, I'd love to see pharma manufacturing jobs come back to the US.  In reality and having watched up close as many companies struggle with this, I'm not sure how easy this will be. I will remain hopeful this new administration can make an impact on bringing pharma jobs back to the US but this will mean.....less regulation.

Less Regulation...faster approvals or more tax reforms?

This is probably the one topic that I've seen cause the most concern for our industry over the last 24 hours, especially with the issuance of Trump's latest executive order (EO). I, like many of you, was left puzzled by the EO issued yesterday and spent the evening wondering what that would mean for our future. After watching the video from today's meeting between Trump and pharma execs, I feel like I have better understanding of what he mean when he says less regulation for our industry but I'm even more convinced that change won't be fast as I'm not convinced everyone is on the same as to what less regulation means. 

One of the regulatory challenges the new administration focuses on is speeding up the drug approval process. Efforts have been put forth by previous administrations aimed at doing the same thing with some improvement achieved. However, speeding up the drug approval process doesn't speed up the drug development process. The drug approval process in only a piece of the overall drug development but I'm not sure if our new administration understands that: 

"15 years, $2.5 billion to come up with a product where there's not even a safety problem. So it's crazy. I’m surprised you can't get them to move faster than that.”

This quote is actually referencing the entire drug development process...not just the drug approval process (which most of us define from the time a submission is made to the FDA to the time we receive approval which in the last several years has been averaging about 10 months for drugs and biologics).

Our drug development process is difficult and we spend years, and sometimes decades, trying to find that one compound that will actually work. But we, human beings, are complex biological systems and most of us are truly unique individuals making the pursuit for new therapies challenging to say the least. Out of thousands of potential new therapies, very few make it out of R&D let alone get approved (see graphic below from PhRMA.org).

I know how difficult the drug development process is from first hand experience. Many years ago, I worked in a drug development lab. I left that job because I was getting so frustrated with failure after failure. It was incredibly depressing. (For those of you who may not work in pharma but want to understand what this is like, Julia Belluz, from Vox.com, summarized the drug development process as "painstaking tinkering and a dash of luck" (I might say more like a pinch or a smidge of luck). 

Since then, I've supported multiple drug approval processes at various organizations. Yes, these are complex...especially if you have (or are pursuing) drug approval in multiple markets...imagine getting and maintaining drug approvals in 50+ markets around the world, most with their own regulations.  I don't think that there are many of us working in this space who wouldn't love to see a simpler, faster approval process. '

I think our industry would also welcome less regulation that supports innovation in the area of drug development. Finding more medicines to treat various diseases has to be a good thing. However, I do believe we need to keep in mind that not all medicines treat "life or death" conditions (those where a patient would otherwise die as is discussed in the video above). So we can't just say that we don't care about efficacy of a drug and only focus on safety. Why would I want to take any medicine that hasn't been proven to fix what's wrong with me.... unless, well, I was dying? In that case, I think all the rules go out the window and I, like many people in similar situations, would be willing to try novel medicines. Now, if I wasn't dying, then my expectations are different. I expect medicines I take when I'm sick or in pain to work. And yes, I know we have compassionate use regulations but from what I can tell, I'm not sure if they work very well.

In listening to our industry representatives, what they seem to be looking for in less regulation sounded much more like tax reform. Hmmm....I'm not sure we're all on the same page yet as to what less regulation look like.

For now, like many of you, I wait to see what comes next...hoping for the best... but until then continue to stay on my current course.

Note: Opinions expressed in this post are solely my own and do not express the views or opinions of my employer (past, current or future).