A major congressional effort to spur medical innovation passed another milestone today when a House of Representatives committee signed off on the 21st Century Cures Act.
The bill, developed by representatives Fred Upton (R–MI) and Diana DeGette (D–CO), revamps policies and provides new funding for the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). Approved unanimously by the House Energy and Commerce Committee, the bill contains a few changes from a version introduced in April.
As before, the measure authorizes annual $1.5 billion raises to NIH’s budget for 3 years and also provides $10 billion over 5 years in mandatory funding for a new NIH Innovation Fund. Annually, at least $500 million of the fund will support the new Accelerating Advancement Program, which would provide matching funds for NIH’s 27 institutes and centers for research in areas including biomarkers, precision medicine, infectious diseases, antibiotics, and basic research. The remainder would go to young scientists (at least 35%); high-risk, high-reward research; and NIH intramural research. This is somewhat different from an April draft bill that would have directed the Innovation Fund to young scientists, precision medicine, and a third, unnamed category.
The current bill has also revised requirements for a new NIH 5-year strategic plan. An early draft called for NIH to make “resource allocation decisions” in line with economic considerations. Now, the plan is to be shaped mainly by “scientific opportunities,” wording changes supported by the biomedical research community. The bill also creates a controversial “capstone award” for senior scientists to wind down or pass on their research programs.
As part of reforms to FDA, the latest draft tries to address concerns that the many new requirements of the agency under the bill would stretch its limited resources. These include gathering data on the natural history of diseases, incorporating patient feedback into the evaluation of new therapies, and qualifying new drug development tools like biomarkers that measure a patient’s response to a drug. A new amendment would set up a Cures Innovation Fund to dole out an annual $110 million for the next 5 years for several of these projects.
The lawmakers have also reinserted a provision giving 6 additional months of marketing exclusivity to drugs approved for rare diseases, an incentive for drugmakers that had been removed in a previous version.
The bill goes next to the House floor for a vote; Upton and DeGette are aiming to pass it this year. It will then need to be reconciled with the Senate’s version. Lawmakers in the Senate’s Health, Education, Labor and Pensions Committee are slowly developing their own biomedical innovation bill, but they haven’t indicated a timeline for its introduction.
With reporting by Kelly Servick.