21st Century Cures Act Passes House, Now Must Navigate Senate

Xconomy National — 

The U.S. House of Representatives took a big step this morning toward major changes in the federal government’s relationship to biomedical research, funding, and regulation. The chamber passed the 21st Century Cures Act, a bill championed early on by a Democrat and a Republican, by a vote of 344-77, an astonishing percentage in this age of partisan acrimony.

The bill aims to speed the development and approval of drugs and devices; provide more financial carrots for making products for small patient populations; and stabilize federal funding for basic biomedical research.

Passage in the House was due in no small part to the bill’s original sponsors, Reps. Diana DeGette (D-CO) (pictured) and Fred Upton (R-MI), whose work—appearances, town halls, info-gathering sessions—for more than a year leading up to the vote at times resembled a permanent campaign.

But the Cures Act still must get through the Senate, where single opponents can often hold popular legislation hostage. And, despite the strong support in the House, critics are asking if the rush to approve new drugs might tilt away from traditional safeguards too much. Fiscal hawks will no doubt pick through the costs associated with the bill, as reported last month by the Congressional Budget Office.

If it does get to President Obama’s desk, the act will likely look different than it does today. It has already been through several edits, at one point earlier this year getting cut back from 400 to 200 pages long.

As it stands today, these are some of its major goals:

—Reauthorize the National Institutes of Health and including an extra $1.9 billion a year for a new “innovation” fund focused on precision medicine and young scientists. (The White House this week applauded the new funding but raised concerns that it would come at the expense of other items in the federal budget because of the spending caps imposed by sequestration.)

—Requiring FDA to make new tools and concepts—such as biomarkers, new clinical trial designs, and surrogate endpoints—easier for drug makers to incorporate into their product development.

—Speed up the regulatory pathway to approve biomedical products, including antibiotics to treat drug-resistant bacterial infections.

—Extend the patent protection for drugs that treat rare diseases by six months and extend through 2018 the priority review voucher program that grants companies a sped-up drug review as a reward for bringing to market a treatment for a rare pediatric disease. (Xconomy reported on an example of the voucher program here.)

—Establishment of a public-private oversight committee, dubbed the Council for 21st Century Cures, that would bring together the heads of the NIH, FDA, and other government agencies with patient advocates, industry representatives, and health care providers.