The U.S. House of Representatives is expected to
pass a $6.3 billion piece of legislation on Wednesday designed
to spur medical innovation, speed access to new drugs, expand
mental health treatment, and combat opioid abuse.
The bill, known as the 21st Century Cures Act, provides $4.8
billion to the National Institutes of Health (NIH) over 10 years
to support brain, cancer and precision medicine research. It
also provides $500 million to the Food and Drug Administration
to approve drugs and devices more quickly.
President-elect Donald Trump has promised to cut "red tape"
at the FDA. He has not commented specifically on 21st Century
Cures. The U.S. Senate is expected to vote on the bill next
week. It is expected to pass, though possibly not before some
additional changes are made. It would then go to President
Barack Obama for signature.
The bill calls for $1 billion over two years to treat and
prevent opioid abuse, including improving prescription drug
monitoring programs, training for health care providers, and
expanding access to opioid treatment programs.
Critics of the bill, including Senator Elizabeth Warren of
Massachusetts, a Democrat, said it contains too many give-aways
to the pharmaceutical industry and will allow companies to push
treatments with limited proof of efficacy.
Speaking on the Senate floor on Monday, Warren said she
could not vote for the bill despite its many positive elements
and would not be a "lackey" for the drug industry.
Warren, along with Republican Senator Charles Grassley of
Iowa, also objects to a provision that would allow companies to
hide payments to doctors under the auspices of continuing
medical education. Grassley co-authored the Sunshine Act which
led to the creation of a database listing drug and device
company payments to doctors.
"A lot of earlier payments to doctors were under the
umbrella of Continuing Medical Education," Grassley said in a
statement on Monday. "We shouldn't create a loophole that would
let drug and medical device companies mask their payments to
doctors under a payment category that's too broad and could gut
the spirit and the letter of the Sunshine Act."
The bill would add an additional reporting exemption
for physicians who receive indirect payments for speaking fees.
Patients groups hailed the bill, saying it would bring
patient voices to the center of the drug approval process.
"This is a patient-centered bill," said Ellen Sigal, chair
and founder of Friends of Cancer Research, a patient advocacy
organization. "It fosters innovation and doesn't lower safety