The Food and Drug Administration (FDA) was put into place to protect consumers
from companies looking to peddle ineffectual and dangerous drugs that
have not gone through extensive testing to ensure that their side effects
do not put consumers unnecessarily at risk. Part of the FDA’s requirements
dictate the processes that pharmaceuticals and other companies must adhere
to before a product may enter the mainstream market. At the various stages
of investigating the effect of a new product or drug, there are certain
“guinea pigs” used to test out the effect that the drug may
ultimately have on its consumers if it does manage to make it onto the market.
Role of the FDA in Experimental Drugs, Products, and Devices
The purpose of the FDA is a noble one, but at times, it may require overly
burdensome procedures for drug testing when a product may take years to
finally hit the shelves. This can have devastating effects for those consumers
who would have otherwise been the recipients of the drug, had they not
passed away before the product was released on to the market. With this
issue in mind, many states are evaluating its protective practices for
experimental drugs, especially in cases where the patients are terminal
and likely to die otherwise.
“Right to Try” Laws in the United States
According to the
Baltimore Sun, there are 33 states in the United States that have passed laws that help
dying patients access experimental, medical treatments that may give them
one last attempt at life. These laws are known as “Right to Try” laws.
Maryland’s “Right to Try”
Maryland recently introduced its own
“Right to Try” Law outlining which patients are eligible to take advantage of this new law.
House Bill 584, an eligible patient under the law is one who:
- Is Terminally ill, which is defined as a condition, disease, or disorder
that will result in the death or permanent unconsciousness, without life-sustaining
processes, and will most likely not recover within 12 months;
- Has considered all other possible FDA-approved treatment options;
- Has been counseled by a medical professional who recommended the use of
the experimental drug, device, or product;
- Has given informed consent to use the experimental drug, device, or product; or,
- Is a minor and/or lacks the capacity to provide informed consent, but has
a parent or legal guardian who gives informed consent on the individual’s
behalf to try the experimental drug, device, or product.
experimental drugs, products, and devices discussed within the bill must have already successfully satisfied the
requirements of Phase I of a clinical trial, but it has not yet been approved
by the FDA for consumption, and has been permitted to continue its clinical
trial by the FDA. Phase I of any clinical trial is to determine the drug’s
risk to the consumer, rather than the effectiveness of the drug which
is evaluated in later phases.
The Benefits and Issues of “Right to Try”
There are many advocacy groups that claim that removing the restrictions
would permit terminal patients to have a new chance at life and provide
the administrators and researchers of the clinical trial valuable information
about the effects of the drug on this population, in hopes that it might
not only save these patients, but future patients, as well.
However, there are other concerns presented by patient protection groups
about possible exploitation of this vulnerable population that could require
investigation from food and drug ethics offices. There have been cases
in which physicians and drug companies are looking to exploit and prey
on these vulnerable patients and charge them pretty penny. Some patients,
under the Right to Try legislation, have spent significant amounts of
money on drugs that have not been proven effective, or may lead to worse
quality of life.
Charles County, MD Personal Injury Lawyers that Fight for You
If your physician prescribed you or a loved one a medical treatment whose
side effects have caused significant injury or death or performed a medical
experiment on you without informed consent, it is important to consult
with an experienced personal injury attorney. Please call the
Law Office of Robert R. Castro at (301) 804-2312 for a confidential consultation.