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The Daily Signal
These Senators
Say Their Bill Would ‘Unleash’ Lifesaving Drugs
Natalie Johnson
December 14, 2015
The process of approving new drugs and medical devices would be sped up
under a bill offered by two conservative senators.
Sens. Ted Cruz , R-Texas, and Mike Lee, R- Utah, introduced legislation
Thursday to accelerate how fast the Food and Drug Administration OKs
drugs and devices.
Before a drug can reach the U.S. market it undergoes extensive scrutiny
from the agency to win the federal government’s stamp of approval.
While the process is intended to protect consumers from dangerous, even
deadly, side effects, the FDA often is criticized for excessive delays
that prevent Americans from receiving potentially lifesaving treatments.
“We need to tear down the barriers blocking a new era of medical
innovation, and the primary inhibitor is the government itself,” Cruz
said in a prepared statement, adding:
Our legislation will unleash lifesaving drugs and devices in the United
States, help mitigate critical drug shortages in the U.S., and put
downward pressure on the prices of medical devices and drugs as well.
The Cruz-Lee legislation would require the FDA to expedite review of
any drug, device or biological application already approved and sold in
“developed and trustworthy” nations.
Reciprocal approval, the senators said, would give those who are
suffering from chronic or life-threatening conditions fast-tracked
access to drugs and medical devices demonstrated to be safe in specific
countries.
In the United States, it takes on average more than a decade for a new
drug to reach store shelves and, according to a Forbes analysis, that
process costs companies roughly $350 million.
Cruz said allowing treatments already used in trusted nations would
spark a “supply-side medical revolution” that could drive down costs.
The bill would give the FDA 30 days to accept or reject a
sponsor’s application to bring “qualified medical products”—those
already approved and sold in developed nations—into the U.S. Those
nations would include Israel, Australia, Canada, Japan and members of
the European Union.
The legislation, dubbed the Reciprocity Ensures Streamlined Use of
Lifesaving Treatments Act, includes a congressional backstop if the FDA
rejects an application. It would allow Congress to override an
FDA-denied application with a joint resolution, which requires a
majority vote and the president’s signature.
Although the FDA needs much broader reform, Lee said, the bill would
bring “lifesaving treatments” to “some of the most vulnerable.”
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