Thumbs Up/Down

Vowing to help, Trump manages to spark an angry protest against policies and a plan to revamp the FDA

Endpoints assesses the big biopharma stories of the week, with a little added commentary on what they mean for the industry.

thumb down President Donald J. Trump

Whether you love Trump or hate him, and you’ll find few people in between those two sentiments, he’s made a huge impact on the biopharma world in the first few days as president. In many ways, it’s been a toxic affair right from the start.

First, Trump managed to raise quite a few biopharma hackles with his early executive order banning travel from 7 predominantly Muslim countries. True, none of these countries are likely to register as big players in science and drug development. But a poll of our readers, along with individual comments from a large slate of executives, unveiled a clear fear on the part of many green card holders that their world could be turned upside down in a heartbeat.

Fear and uncertainty do not mix well with a fundamental desire to recruit the best staff globally.

The industry response to our survey was extraordinary, with 87% of more than 1,400 execs voicing their disapproval. That’s a big thumbs down from biotech.

thumb down  You say you want a revolution?

Then came Trump’s sit-down with some very appreciative pharma CEOs willing to nod their approval as the president blasted the FDA and promised a wholesale revision of the regulations regarding drug development. No doubt, many critics would have liked to have seen some defiance. The pharma execs, though, were on a lobbying mission. What they want, clearly, is to limit Trump’s appetite for slashing drug prices while gaining swift and immediate tax relief, fattening margins and regaining billions held overseas for immediate repatriation.

That’s all part of their job description, so you shouldn’t act surprised when they go to DC to help make the sale.

As a group of biotech execs made crystal clear to me, though, FDA “reform” isn’t needed or wanted. Yes, there are continuing efforts to streamline the regulatory side of the business in PDUFA VI, but legislation over the last few years has dramatically altered many development timelines. Trump’s loud protests to the contrary, he’s advocating a radical revision at a time the industry is quite happy with where it is.

Reform is a cover for simply lowering regulatory standards dramatically. Once you do that, as just about any biotech CEO will tell you, you will corrupt a process that has become the gold standard for the world. Without an objective decision that a drug’s benefits outweigh ever present risks, you have chaos. And no one in this business with any integrity wants to pit their good drugs against a tidal wave of fake cures that can be sold cheap.

thumb down About those pharma jobs…

Trump likes to talk about bringing overseas jobs back to the US. And the pharma representatives he met with were quick to oblige with some promises of their own. But Trump went looking for new jobs in the wrong place. Big Pharma has been zealous in holding the line on employment, which has frequently called for significant cuts in the US.

As a quick review of the numbers revealed, Eli Lilly, Merck, Amgen and others are better at cutting jobs than they are at adding them. And nothing Trump does or says is going to get anyone really enthusiastic about putting the ax aside. Yes, we’ll get some lip service about manufacturing and so on, but the new jobs in this industry are coming from biotech companies, not Big Pharma.

Maybe that’s something the president should think about before he sets out to “help.”

 


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