If you have an idea to include in the bipartisan initiative known as 21st Century Cures, Fred Upton (R-MI) and Diana DeGette (D-CO) say they are all ears. But speak up quickly: They want to present a bill to the House of Representatives by Memorial Day.
That was the message the two members of Congress provided today at the BIO CEO & Investor Conference in New York. Upton, the chair of the House Energy and Commerce Committee, and DeGette (pictured above), have been convening hearings, discussions, and roundtables around the country to craft legislation that would boost federal support for biomedical research and speed development and approval of new drugs and devices.
The ambitious idea—ambitious for no other reason than its main backers are bipartisan members of Congress—will require far more cooperation across the political aisle, and surely a large amount of funding.
It’s also unfinished, which is why Upton and DeGette asked those in attendance Monday to keep the ideas coming.
“We want your input,” Upton said to the crowd during a chat with DeGette that was hosted by BIO president and CEO Jim Greenwood. “This is not going to be what the bill is going to look like.”
Upton was referring to a roughly 400-page discussion draft that was posted to the Energy and Commerce Committee Website on Jan. 27. (A much shorter summary is here.)
Here are a few of the provisions:
—Even faster approvals for drugs that receive the FDA’s “breakthrough therapy” designation.
—A similar breakthrough designation for medical devices.
—A new regulatory pathway for antibiotics.
—New standards for evaluating surrogate endpoints, which are biological markers that could be used to form the basis for a drug’s approval.
—Easier access experimental, unapproved drugs under “compassionate use” exemptions for seriously ill patients.
Upton said a new document should be out in a few weeks. His goal is to have a bill in front of the House before Memorial Day and on President Obama’s desk by the end of the year. “We really don’t want it to get caught up in the presidential politics of 2016,” he said.
As DeGette explained, backers of 21st Century Cures want to address four broad areas:
1) Integration of patient perspectives into the regulatory process.
2) Modernization of clinical trials. DeGette noted, for instance, that if researchers from institutions in New York and Colorado want to do a research study together, there is a “cumbersome process” in place that renders it “costly and slow.”
3) “Fostering the future” of young scientists. “One thing we’ve heard strongly in forums all around the country is that young scientists are being chilled from going into the profession because they can’t get [National Institutes of Health] grants,” DeGette said, noting how funding for such grants has slowly eroded over time. DeGette and Upton are trying to figure out a way to spur young scientists to continue on.
4) More support for digital medicine.
DeGette also said she hopes to incorporate elements of President Obama’s precision medicine initiative.
Anything linked to the president could be anathema to a certain cadre of Republicans, who now control both houses of Congress. Spending will also be an issue for budget hawks on both sides of the aisle, and so far there’s no estimate of how much 21st Century Cures will cost.
The initiative’s proponents are likely to call for more NIH funding. The NIH’s budget, which was roughly $30 billion for the 2014 fiscal year, has been on the downswing partially due to inflation over the past decade.
DeGette knows the increases are presented will be crucial to winning support in Washington, even if the bill is supposed to be, as Upton said, “nonpartisan” in nature.
“It’s going to be challenging to make all the moving parts work,” DeGette said. “My goal is to have upwards of 400 votes [in the House], and if we really do this right, I think we can have that kind of consensus.”
