Right to Try Fact vs. Fiction

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 Fictitious Claim Fact
 Right to Try
would cut the
FDA out of the

Right to Try not only recognizes the FDA’s important and valued
role in providing for patient safety, but it also works in tandem
with the FDA human safety requirements, payment rules, and
reporting requirements.

Right to Try requires treatments to have passed FDA Phase 1
trials, and that the treatment remains under FDA investigation.
Following FDA rules, manufacturers may only charge for the direct
costs of making the treatment available, and any adverse
outcomes must be reported to the FDA. In fact, nothing in the
Right to Try law affects FDA’s role in drug development or the
current approval process

No patients
have been
helped by Right
to Try
Right to Try is providing hope, patient treatment, and extending
the length and quality of patients’ lives.
Terminal patients like Mark Angelo of Florida credit Right to Try for
not only allowing him to continue an investigational treatment that
would otherwise be available but also for saving his life.
A Houston physician has now treated nearly 100 terminal cancer
patients under the Texas Right to Try law. Some had only three
months to live when they began treatment. Today, years later,
most are doing very well.
The harsh reality is that terminal patients with means are already
seeking these and similar treatments overseas. Right to Try
reduces that obstacle for those Americans who can’t afford to do
Right to Try
threatens the
clinical trial
Only terminal patients who are unable to participate in a clinical trial are
eligible for Right to Try under the proposed legislation.
Patients who are accepted into clinical trials must generally be just sick
enough, but not too sick. As a result, many terminal patients are excluded
from clinical trials because they are too sick.
The FDA’s
program is
While the FDA does approve almost all of the compassionate use
applications it receives, it is beyond comprehension that fewer
than one out of every one-thousand terminal patients would
wish to do so. Something is clearly amiss in a system that is so
bureaucratic and time-consuming that fewer than one-tenth of one
percent of terminal patients can take advantage of the FDA’s
compassionate use exception.
The FDA granted fewer than 1,300 compassionate use requests
in 2015. That same year, more than 1.3 million died from the three
leading disease killers of heart disease, cancer, and chronic
obstructive pulmonary disease (COPD), alone. That does not
include other devastating diseases, such as Alzheimer’s, ALS, and
Parkinson’s. And for every single terminal patient that accesses
compassionate use in the U.S., there are dozens who obtain
access in countries like France and Australia under their countries’
compassionate access programs.
Federal Right to Try legislation would make compassionate use
the rule, not the exception.