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House committee approves bill on speeding medical innovation
http://news.sciencemag.org/funding/2015/05/house-committee-appr
Jocelyn is a staff writer for Science magazine.
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By Jocelyn Kaiser 21 May 2015 5:30 pm 0 Comments
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.
http://news.sciencemag.org/funding/2015/05/house-committee-appr
Jocelyn is a staff writer for Science magazine.
Email Jocelyn
By Jocelyn Kaiser 21 May 2015 5:30 pm 0 Comments
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.
