Thumbs Up/Down

Another biotech games the system, and everyone gets to pay for the fallout

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


thumb down The FDA got played – again

As I write, our story on Marathon and its old, cheap steroid — deflazacort — that it steered to an FDA approval yesterday is gaining some serious traction on social media outlets like Reddit. That’s where the online mob formed for Martin Shkreli, after word spread that he and Turing had hiked the price of Daraprim for HIV users by 5000%-plus. And it’s where you can feel the visceral public anger that’s been building over drug prices.

Once again, we have a company that is playing the system, grabbing a steroid that’s been sold around the world for decades and jacking up the rate by a jaw-dropping amount. $89,000, in this case, up more than $88,000 over what it costs in Canada. Marathon also got a priority review voucher worth hundreds of millions of dollars for its slight trouble, to recognize a contribution for R&D that includes buying rights to a study that was done in 1995 — before the 6-minute walk test became a standard gauge of success.

The FDA gave Marathon every advantage in the books, and then some. Taking another page from the Shkreli handbook, Marathon says it will make sure that only insurers will get gigged, patients shouldn’t have to worry. So unless you pay for insurance, you should have no real qualms. Right?

It’s all perfectly legal. And it’s all perfectly wrong. Until Congress understands and acts decisively to stop it from happening again, the next pricing scandal will be waiting right around the next corner, with someone at the FDA holding its hand. And each of these eruptions will seriously damage biopharma’s reputation at a time it needs to be seen as playing fair.

thumb Scott Gottlieb remains the best choice for FDA commish

Early on Friday Tom Price got the nod to run HHS, as expected. So we should hear anytime now who Donald Trump has selected to run the FDA.

We fear that he’s going to go ahead with Jim O’Neill, a Libertarian with some wacky ideas about approving drugs based on safety alone. That old debate about a drug’s safety/benefit ratio? That would go out the door, along with the rest of the standards that have made US drug development the guiding force for the world.

We hope that Trump chooses Scott Gottlieb. The former deputy commissioner understands what it takes to run the agency, and has the medical credentials to understand the stakes. As John Maraganore said recently, this isn’t like marketing a soft drink, where you choose between Pepsi and Coke. It’s literally a matter of life and death, and the FDA was put in place to make it more about life.

The Marathon scandal just proves once again that too many companies are ready to start fleecing the public at the earliest possible moment. Whoever runs the FDA needs to be prepared for that.

thumb Thank you, biotech, for taking a principled stand

As we reported more than a week ago, it was clear from our snap poll that the biotech industry was solidly opposed to Trump’s travel ban from seven primarily Muslim nations. This week, 166 execs lodged their formal, for-the-record opposition to the ban in a letter published in Nature Biotechnology.

This isn’t just about whether these companies can recruit staffers from these nations. The ban strikes fear in the hearts of everyone working in the United States on an H1-B visa, which is common throughout science-oriented industries in the US. The ban makes all foreigners unwelcome, regardless of the contribution they make to science and these companies. And it threatens the easy movement of talent and ideas, all of which has been an enormous advantage for the US.

Unfortunately, BIO and PhRMA along with most Big Pharma CEOs see no upside in attacking Trump’s executive order, now stayed by the courts. We are not naive. These groups are made to quietly seek influence and lobby for benefits, and there are some huge tax benefits on the table right now. Under any other administration, at any other time, silence could be understood.

But not this time.


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