CHICAGO – Supporters of a new federal health care law, which has implications for drugmakers, researchers, hospitals, doctors and more, say they believe the law, known as the 21st Century Cures Act, will inspire innovation and discovery in medicine.
The law was passed by Congress and signed by President Obama in December. The act modifies a variety of laws and federal rules, including ones addressing drug, device and biologic
development and approval.
The law includes $6.3 billion for
medical research over the next decade.
“The Cures Act is a vast compilation of legislative
provisions reflecting Congress’ attempt to incentivize medical research and
revamp the process by which FDA (the U.S. Food and Drug Administration) approves drugs and medical devices in light of modern
day technological advances,” said Yetunde Oni, attorney at the firm of Reed Smith in Washington,
D.C. “In certain cases, the Cures Act simply
expands the scope of or clarifies previous FDA regulations, while in others, it
grants FDA the authority to implement new drug, biologics or device
regulations. In sum, the act aims at making drug development process more
patient-focused by improving patient access to therapies and information.”
According to Oni, a few of the significant provisions in the 1,000-page
legislation include: an increase in funding for the National Institutes of
Health for medical research; expanding the types of evidence drug and device manufacturers
may use to support their product approval applications; increasing transparency of manufacturers’ policies for drug use; and providing more clarity
on regulation of medical device software.
The changes will also require pharmacists and drug makers to make
the process more transparent and safe.
“In some of these provisions, the Cures
Act requires drug makers to perform certain activities that were not previously
required of them under any federal law,” Oni says. “For example, in a bid to
increase transparency for compassionate use of investigational medical
products, manufacturers of such products are now required to make their policy
for requests for compassionate use of their products available to the general
Supporters of the Cures Act hope the law will mean research facilities
may not need to pay as much for expenses needed for research and development
of drugs. Oni said the legislation now allows drug makers
to use real world experience, reducing reliance on clinical trials to acquire acceptable data.
“This use of real world evidence will reduce the burden of data
collection during clinical trials, as the related data should be readily
available through the electronic health records available in provider settings,”
The Cures Act will not only effect drug makers, but also hospitals, doctors, therapists and other care providers.
“The Cures Act
includes provisions impacting Medicare and Medicaid, such as
Medicare's long-term care hospital (LTCH), infusion drug reimbursement, and
durable medical equipment (DME) policies,” said Kate Brinkley, an attorney with Oni at Reed
Smith in Washington, D.C.