Drug pricing remains the big issue for 2017; Let’s not go down the rabbit hole at the FDA

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

   Drug pricing remains the biggest issue facing the industry in 2017

Perhaps it was appropriate that Time magazine decided to deliver Donald Trump’s thoughts for their Person of the Year cover story in a series of tweet-like remarks. Twitter, after all, is his favorite forum. So we were all treated to a very clear message: I’m going to bring drug prices down. It just arrived with absolutely no insights into how he plans to do that. And that’s the issue we face in 2017. While the regulatory winds have been blowing in biopharma’s favor for years now, drug pricing remains a controversial black box that encourages scandal. It’s also a potent populist issue which can stir mass protests. The industry still has a chance to adopt a commonsense approach to self-regulating price hikes. And there are good reasons to require a transparent list of negotiated prices for people to see what is actually paid, while also prohibiting gouging consumers for old technology. But time is wasting. And hesitancy will only make any public backlash sting all that much more.

  Naming Thiel associate Jim O’Neill as FDA chief would be a disaster for biopharma

Let’s not beat around the bush. The last thing biopharma needs right now is someone like Jim O’Neill at the helm of the FDA. Not a doctor or scientist, O’Neill’s qualifications appear limited to the fact that he is close to Peter Thiel, a Trump loyalist who broke with his Silicon Valley brethren in backing the Republican maverick. So I’m hoping that word that O’Neill — who has said that developers shouldn’t have to prove efficacy before selling a drug — is being seriously considered for the FDA commissioner’s job is really just a way for the incoming administration to be polite to a key supporter before giving the important post to someone more suitable. Half-baked ideas on drug development would undermine the industry, for obvious reasons. An Alice in Wonderland approach to drug regulation with the Mad Hatter in charge isn’t something that inspires trust, which pharma is already badly short of. Let’s hope this idea is nixed, and quickly.

  Janet Woodcock expands her considerable powers at the FDA, which bodes ill for all of us

John Jenkins has had a long and successful career at the FDA, so perhaps we shouldn’t read too much into the news that he’s retiring as head of the Office of New Drugs. But CDER’s Janet Woodcock would appear to be running a power play with her decision to assume the office on an interim basis as she looks for a successor — who may already be waiting in the wings, from what we hear. The agency experienced something close to a civil war over the approval of Sarepta’s Duchenne muscular dystrophy drug. There’s no solid data on efficacy, or anything for that matter. Top officials waged war against Woodcock’s insistence on an OK. They lost. Now Woodcock will be in a better position to make sure that the next time she decides something, opponents will be less likely to speak out. That’s not good for the FDA, or anyone else.

  Let’s celebrate the best of the Cures Act, but watch out for lowered standards

There are many positive aspects to the 21st Century Cures Act that would be hard not to applaud. Billions more for research. Something for the opioid epidemic. And so on. If you want to win bipartisan support for a bill, you need to spread the rewards around. Lawmakers even agreed to take out many of the most objectionable parts of the legislation. We remain opposed to a lowering of standards on new drug indications, though. We’re slipping into a new era where drug approvals are coming faster than ever, often with the encouragement of regulators. But the best approach is to stick with the gold standard on data, while looking for the most efficient path that can be blazed on finding it. If it becomes apparent that the FDA is simply lowering its standards to accommodate drug developers, the resulting backlash will negatively affect the entire industry.

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