Biomedical Innovation ‘Cures 2.0′ Draft Bill Expected in June


May 15, 2021 3:53 pm

Draft legislation to update the landmark biomedical innovation law 21st Century Cures will likely come out in early June, lawmakers behind the bill said.

Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) indicated they want to pass their bill, known as Cures 2.0, by the end of the year, although they acknowledged the pandemic has set back their work.

The bill offers a chance for an increasingly divided Congress to pass legislation to remove hurdles to cutting-edge treatments when science is moving at a rapid pace.

The 2016 law has led to better screening for certain cancers, better understanding of the human brain, advances in regenerative medicine and more funding for Alzheimer’s research, a record number of drug approvals, and new opportunities for young scientists, DeGette said.

“That effort has been really hailed as one of the most comprehensive pieces of health-care legislation,” DeGette said at the Alliance for Regenerative Medicine’s Cell & Gene Legislative Fly-In, the group’s policy and advocacy event, Monday.

“But what we realize is that we’re still not there, that there were still some things that weren’t perfected under 21st Century Cures.”

The draft bill will focus more on the delivery of cutting edge treatments, whereas 21st Century Cures (Pub. L. 114-255) aimed to modernize the development of new therapies by focusing on the Food and Drug Administration and the National Institutes of Health. The legislation will include language to fold in the Advanced Research Projects Agency for Health, the new agency within the NIH for which President Joe Biden requested $6.5 billion in his initial budget proposal to build. The new agency would help translate discoveries into patient care, based on a program at the Pentagon and the Department of Energy that paved the way for the internet and GPS.

DeGette and Upton recently met with the Biden administration to discuss the ARPA-H proposal and have recently begun discussions with their Senate counterparts. The bill will include language on how to improve pandemic preparedness, and Sen. Patty Murray (D-Wash.) has also said she’s working on bipartisan legislation to prepare for future pandemics. Murray is the chair of both the Senate health committee and the health spending panel on the Senate Appropriations Committee.

Lawmakers are also looking for recommendations on how to modernize the Centers for Medicare & Medicaid Services to help speed up their decision-making process, DeGette said. “It doesn’t do any good if you have drugs or devices that people can’t afford.”

They indicated the draft bill is just a first step and they are looking for feedback to shape the next iteration of bills to speed the delivery of new drugs and devices. For example, there currently isn’t language on value-based agreements—which tie payment to how well the treatments actually work—but DeGette indicated they are open to it.

“Fred and I are not researchers; we are just lowly members of Congress,” she said to the regenerative medicine group. “If we don’t get those finer points that are specific to regenerative medicine, then we can’t make as robust or effective of a bill.”

Open to User Fee Legislation

The lawmakers indicated they were open to tying Cures 2.0 to upcoming user fee legislation, as negotiations between industry and the FDA are ongoing with the current agreement expiring in September 2022. The FDA collects user fees from drug manufacturers, and in return, the agency commits to performance goals.

DeGette said it’s unlikely a bill that includes the ARPA-H proposal will be folded into the next user fee agreement. At the same time, she said, “We just want to pass the bill. So whatever method we can do, we will do.”

The bill will include a provision for increasing diversity on clinical trials. There was some language in the 2016 21st Century Cures, but “we’re still not yet where we need to be, and as Fred says, we’ve really realized during Covid that we need to get better data in all the clinical trials,” DeGette said.

Upton added there’s a proposal to require the Department of Health and Human Services to submit a report to Congress regarding the current state of cell and gene therapies, particularly identifying any regulatory challenges for the FDA.