"The Good Place" is my daughter’s favorite TV comedy. If you’ve never heard of it, think of the Sharks and Jets, only in the afterlife, and with the fate of the universe at stake.
There’s plenty of silliness, a few love triangles and—spoiler alert—a demon in a Ted Danson suit, but along about season three the show came up with a pretty astute observation. It’s more difficult than ever to be a good person.
Many day-to-day decisions are toss-ups between some sort of damage on one hand and a different sort on the other. Avocados are healthy, but their popularity is causing deforestation in Mexico. Almond milk is vegan, but growing almonds is a water-sucking environmental disaster. Buy a bargain blouse, and discover it came from a piecework sweatshop whose roof just collapsed. The only safe clothing purchases seem to be from thrift stores, high-end made-in-Italy fashion houses and Patagonia.
Point is, the world has grown so complicated, we often have no idea about the consequences of our actions—and when we do try to do our due diligence, we find a snarl of inputs and outputs that travel in dozens of directions.
Believe it or not, this leads us to pharma and the outlook for 2020. Reading this year’s forecasts, I was struck by the fact that they show just how many variables make up the industry equation these days—and how much more complex the already complicated business of drugmaking has become.
Consider manufacturing. Drugmakers thought they knew exactly how to make certain commonly used generics. But because of new testing methods and stepped-up scrutiny, the FDA has flagged potential carcinogens in even more drugs. Zantac, for instance. The agency thinks those finds will continue. Fixing the problem? Hard to know just how—and even more difficult to know just how long it could take.
And those are old, small-molecule drugs. Consider, meanwhile, the trouble some CAR-T drugmakers have had getting batches of these personalized treatments up to spec.
Strike an M&A deal? Be prepared for a long investigation by the Federal Trade Commission, and it’s not just product overlap triggering scrutiny. Forecasting sales? The rebate system is in flux, Congress might or might not index U.S. prices to those overseas, and you might have to launch an authorized generic to lower costs for patients—and even then, it might not work.
Pharma marketing is turning to digital to identify and reach niche audiences rather than pumping up budgets for mass-market TV. The rise of gene and cell therapies mean drug launches require more upfront negotiation with payers, plus brand-new payment models and certified treatment centers—and the specialized, often personalized, manufacturing mentioned above.
Even a field that has become so lucrative that drugmakers can’t ramp up fast enough—cancer drugs—is more targeted and niche-oriented with each data release. Patient populations are sliced thin, sometimes to just a few thousand patients, and there are so many clinical trials, recruiting the right patients is a business in itself.
This isn’t a woe-is-pharma lament. No, the world is more complicated for everyone—just talk to a schoolteacher, for one example. It’s not an apologia to give drugmakers a pass for bad behavior—it may be tough to pick the most ethical banana, but the right choice in business is a bit more obvious.
What is it, then? A recognition that 2020 is almost here. And while we won’t have flying cars or robot housekeepers, we will have more next-gen drugs, loads more clinical data, thousands—if not millions—of quality control inspections, a dozen or so much-anticipated drug launches and one major U.S. election. We hope you’ll follow them with us. And in the meantime, have a happy and safe holiday season.