Since 1987, the FDA has had
regulations in place that have
enabled patients to access medicines
that are still in development.
Granting access would
typically be considered once a
medicine has shown positive
results in clinical trials and has
also been shown to be safe.
However, it cannot be stressed
enough that it is the drug manufacturer
who decides to make
unapproved drugs available, and
they are not under any obligation
to comply with a request
from a patient or healthcare provider.
Current FDA
Regulations
Right-to-try laws are U.S. state
laws and a federal law that were
created with the intent of allowing
terminally ill patients access
to experimental therapies
(drugs, biologics, devices) that
have completed Phase I testing
but have not been approved by
the Food and Drug Administration
(FDA). Prior to the passage
of right to try laws, patients
needed FDA approval to use
experimental drugs. Currently,
41 U.S. states have passed right
to try laws.
The value of these laws has
been questioned on multiple
grounds, including the fact that
pharmaceutical manufacturers
would have no obligation to
provide the therapies being
sought. A federal right to try
law was passed in May 2018,
but as of June 2019 only two
patients had been accepted for
experimental therapies.
According to Scott Gottlieb,
who served as commissioner of
the FDA under President Donald
Trump, the FDA had approved
99% of patient requests
for access to experimental drugs
prior to the passage of right to
try legislation.
As of August 2018, 41 states
had enacted such laws: Alabama,
Alaska, Arizona, Arkansas,
California, Colorado, Connecticut,
Florida, Georgia, Idaho,
Iowa, Illinois, Indiana, Kentucky,
Louisiana, Maine, Maryland,
Michigan, Minnesota,
Mississippi, Missouri, Montana,
Nebraska, Nevada, New Hampshire,
North Carolina, North Dakota,
Ohio, Oklahoma, Oregon,
Pennsylvania, South Carolina,
South Dakota, Tennessee, Texas,
Utah, Virginia, Washington,
West Virginia, Wisconsin, and
Wyoming.
In January 2017, a federal right
to try bill was introduced in the
Senate by Republican Ron
Johnson of Wisconsin. Johnson
was able to pass his bill in the
Senate on August 3, 2017 in a
unanimous consent motion.
Johnson had threatened to hold
up a Senate vote on the FDA
Reauthorization Act of 2017
(FDARA), a must-pass piece of
legislation that allows the FDA
to operate, if an amendment on
right to try was not added to that
bill. Johnson agreed to drop a
hold on FDARA in exchange
for a unanimous consent motion.
A companion House bill
was introduced in February
2017; the following month it
was referred to the House Subcommittee
on Crime, Terrorism,
Homeland Security, and Investigations.
On March 21, 2018, the House
of Representatives passed a
right to try bill, sending it to the
Senate for consideration. On
May 22, the Senate passed
S.204, the 'Trickett Wendler,
Frank Mongiello, Jordan
McLinn and Matthew Bellina
Right to Try Act', and sent it to
President Trump who signed it
on May 30, 2018 creating a uni-