CLINICAL NEWS
that are getting held up in the approval process
and patients are dying. [The bill will] streamline the bureaucratic process without making
important compromises on safety.”
The proposed bill would allow the U.S. FDA
to approve new medical devices based on limited patient case studies and medical journal
articles rather than extensive clinical trials, as
well as allow companies to make changes to devices without further U.S. FDA approval. In addition, approvals could be based on biomarkers
(such as a drug’s effect on a tumor), not solely
on improved patient survival.
Though many in the pharmaceutical industry, patient advocacy groups, and medical
organizations are in support of the bill, those
opposed to the bill suggest that it will only
provide more benefits for the pharmaceutical
and medical device industries – rather than for
patients.
Health policy officials are concerned
that the bill may erode certain standards of
evidence for drug approvals by weakening the
FDA’s scrutiny, which could impact patient
safety. The White House also issued a statement that questioned a provision of the bill that
would extend a company’s exclusive rights to
market brand-name drugs if they are repurposed to treat a rare disease. The Congressional
Budget Office estimated that this provision
could increase prescription drug spending by
$869 million between 2016 and 2025.
The Senate is working on its own version of
the bill. Congressional leaders hope to finalize
a bill by the end of the year in order to begin
increasing funding to NIH by October 20 M