What is Ahead for US Pharma?

It has been a wild ride this past week. I know my family and I have been on an emotional rollercoaster, and I bet many of you are feeling the same way. One question that keeps popping up in our household (and probably yours too) is: “What does this mean for my job, and should I be freaking out?”

Short-term outlook: Keep calm and carry on

First things first, take a deep breath. In the immediate future, it’s unlikely that we’ll see any massive shifts in pharma world. Most of us can probably continue our daily grind without too much disruption. So, for now, it’s business as usual, folks! Unfortunately that business has been pretty tough the last two years.

Long-term forecast: Cloudy with a chance of uncertainty

Now, here’s where things get a bit murky. The long-term outlook? Well, it’s like trying to predict the weather a year from now – pretty darn tricky. What we do know is that this situation has cranked up the uncertainty dial, and let’s face it, uncertainty in the pharmaceutical world is very unwelcome.

We already have a hefty dose of uncertainty due to the 2024 Supreme Court decisions, which are slowly starting to have impact but the boundaries are really unknown. Add to that an incoming administration with a noted dislike (and a set of vendettas) against the HHS and FDA, and government employees. And on top of that we have the wild card of Robert F. Kennedy Jr. being able to “go wild on health” – whatever that ends up meaning but my fear is nothing good.

But I also need to be pragmatic, and as a quality individual involved in risk management and managing uncertainty, I need to start evaluating impacts. Here are the things I am looking at.

On-Shoring

On-Shoring has been a growing conversation for years. We are an incredibly global industry and have been hard hit by a variety of supply disruptions:

1. Global Pandemic: COVID-19 threw a massive wrench into our well-oiled supply chain machine.
2. Geopolitical Tensions: The ongoing trade tiffs between major economies have kept us on our toes.
3. Natural Disasters: Mother Nature hasn’t exactly been playing nice lately.
4. Labor Shortages: Finding skilled workers has become a bit like searching for a needle in a haystack.

Add to this cocktail the ongoing GMP issues with sites in key manufacturing countries like India and China, and you’ve got a recipe for some serious supply chain headache,

Add to that we have a whole lot of talk of tariffs. The incoming Trump administration is practically drooling to raise tariffs which will have some serious implications:

• Market Access Issues: Suddenly, selling your products in certain countries becomes a whole lot trickier.
• Higher Costs: Tariffs often mean higher prices for imported goods.
• Retaliation Risks: When one country imposes tariffs, others tend to follow suit.

The Critical Component Conundrum

Here’s where things get scary. We are seeing an increase in both price and availability issues for critical raw materials and components. And it is not just about overseas suppliers – even our domestic suppliers are feeling the heat. Remember the great plastics shortage that hit our Single-Use System (SUS) component suppliers? That is potentially just the tip of the iceberg.

The Ripple Effect

Now, let’s connect the dots:

1. Supply Chain Vulnerability: Our global supply chains are showing their weak spots.
2. Critical Item Shortages: There’s a growing concern about shortages of essential items.
3. Price Hikes: As supplies tighten and tariffs kick in, prices are heading north.
4. Market Access Challenges: A potential trade war could make it tough to serve international markets from the U.S. And remember, we are a very global industry.

Risk Management Approach

1. Diversify Supply Sources: Don’t put all your eggs in one basket (or country).
2. Build Resilience: Create buffer stocks of critical components.
3. Explore On-Shoring Options: Look into bringing some production closer to home.
4. Stay Flexible: Be ready to pivot your strategy as the global situation evolves.
5. Plan for multi-country impact: Evaluate what happens when other countries start retaliating and it becomes difficult to get clinical or commercial supply into a country.

Regulatory Changes

Here are my fears where RFK Jr can really do damage. He may push for less stringent approval processes for certain drugs or treatments he favors, potentially allowing more alternative or “natural” products to enter the market. Conversely, he could impose stricter regulations on vaccines and other pharmaceutical products he views skeptically (which is all of them).

There may be efforts to roll back regulatory controls that currently protect public health, potentially allowing unproven treatments to reach consumers more easily. All of this uncertainty is going to be difficult and will impact company’s ability to raise funds. Which will impact the job market. And it has been a bad couple of years for layoffs.