Executive Summary

It is hard to find anything in the 21st Century Cures Act that justifies the hyperbole around its signing – or the criticism that it undermines patient safety. But, for the biopharma industry, the hype is important as a sign that pro-innovation messages have bipartisan appeal.

One thing everyone in the room for the signing of the 21st Century Cures Act on December 13 agreed on is that it was a really big deal.

Here is what President Obama had to say about the new law:

The United States of America should be the country that ends cancer once and for all. We’re already closer than a lot of folks think, and this bill will bring us even closer, investing in promising new therapies, developing vaccines, and improving cancer detection and prevention. Ultimately, it will help us reach our goal of getting a decade’s worth of research in half the time.

The Speaker of the House Paul Ryan also thought the bill was a game-changer:

We are about to change the very way we do medical research and development in this country. With this bill, we are laying the groundwork for medical breakthroughs that will help countless Americans suffering from what today are considered incurable diseases.

There were some critics, too, who saw the bill in a very different light. Like Sen. Bernie Sanders:

The greed of the pharmaceutical industry has no limit, and this bill includes numerous corporate giveaways that will make drug companies even richer.

If you read all those quotes and then actually looked at the provisions of the new law, you might think of another prominent (if long departed) public voice: Peggy Lee.

Is that all there is?

For all the hype, the “Cures” law ended up being a package of distinctly modest reforms. A modest boost in NIH and FDA funding (subject to future appropriations). A modest package of regulatory changes, most of which were bound to part of the next user fee law even if Cures didn’t pass. And – despite what Sanders said – no significant new incentive programs for drug developers. (Also see “The Evolution Of 21st Century Cures Legislation” – Pink Sheet, 29 Nov, 2016.)

So it is frankly hard to see how the Cures law really brings us any closer to curing cancer or reinventing biomedical R&D. Nor is it easy to credit the critics who warn that the new law is a threat to patient safety.

But, biopharma companies shouldn’t miss the forest for the trees. The bipartisan hype around “Cures” is itself an important achievement. As Friends of Cancer Research CEO Jeff Allen notes in a new podcast with Prevision Policy Founder Ramsey Baghdadi, the direction of “Cures” was heavily influenced by the amazing response members of Congress received at home. Americans are eager to see advances in biomedical innovation, and their elected representatives were eager to demonstrate that they share that goal.

In the end, it turns out to be much easier to get a broad bipartisan majority to vote in favor of “Cures” than it is to make significant changes to the way biomedical research is conducted and regulated.

But the biopharma industry shouldn’t overlook the importance of being able to rally legislators around the goal of enhancing innovation. It just might come in handy if and when price controls are back on the agenda.

https://pink.pharmamedtechbi.com/PS119684/The-Real-Impact-Of-Cures-The-…