Barron’s D.C. man focuses on 21st Century Cures Act

Jim McTague devotes his latest “D.C. Current” column in Barron’s to legislation moving through Congress that would speed up the Food And Drug Administration’s approval process.

BOTH THE HOUSE AND SENATE MEASURES aim to streamline the discovery-development-delivery cycle to accelerate the pace of cures, without introducing recklessness into the process. Speeding research and approval, in turn, should significantly lower the costs and risks of developing medicines, former FDA Commissioner Andrew von Eschenbach told me last Wednesday at an event sponsored by the nonprofit Alliance for Health Reform.

A faster cycle, he said, should particularly appeal to venture investors, who have been moving away from the space because of skyrocketing development costs and lengthy wait times that often are a consequence of an outmoded FDA approval process. “When the business model makes sense, then the whole system benefits,” he said. Capital, as Barron’s readers certainly appreciate, makes civilization go round.

The pharmaceutical, biotech, and life-science industries, of course, have been among the stock market’s brightest stars this year—in part, I suspect, because of favorable prospects for this legislation. Although Republicans and Democrats disagree on almost everything, both parties and the president strongly support improvements to the plodding, overly cautious FDA approval process. Nearly as important, the House bill also has the vocal backing of patient groups and pharmaceutical and medical-device manufacturers. Credit this to the efforts of the bill’s sponsors—Fred Upton, the Michigan Republican who chairs Energy and Commerce, and Diana DeGette, a Colorado Democrat on the committee—for engaging all of the stakeholders last year.

We the patients, of course, are intended to be the primary beneficiaries of the legislation. But there are economic benefits for the nation, as well. Absent an overhaul of the FDA’s approval process, there’s compelling reason for pharmaceutical and medical-device makers to shift some research jobs from the U.S. to the European Union, which boasts a less burdensome approval regime.