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Cameron Adams
Mr. Rogers
Government 5
29 October 2015
Right to Try
Imagine you have been diagnosed with amyotrophic lateral sclerosis and have been
notified that you have a maximum of 2 years to live, due to the fact that there is no current
medication to cure your condition. The reality that your days are now numbered becomes too
much to bear and you spiral into depression, until you discover that a new drug has just been
created. This new miracle drug contains many risks, but it also has the potential to save your
life. You begin to regain hope and disregard all risks, when you realize the drug will not pass
FDA approval in time to utilize it. This particular situation is one that millions of Americans
experience annually. Medication that could save them has been created, but has not been placed
through FDAs protocol to approve the drug. As of June 2015, an effective solution has been
proposed to end the occurrences of this heartbreaking scenario: Right to Try. Right To Try
allows terminally ill Americans to try medicines that have passed the first phase of the FDA
approval process, but are not yet on pharmacy shelves. Right To Try expands access to
potentially life-saving treatments years before patients would normally be able to access
them (Altman). The Right to Try law was created by the Goldwater Institute on July 9, 2015.
It allows patients to access new drugs after passing only phase 1 of the 9 phase protocol that
FDA approved drugs generally go through. Right to Try should be the policy used nationwide

for all patients seeking the use of experimental drugs because of how extensive the current FDA
approval process is, the fact that the current compassionate use policy allows for only a
fraction of applicants to receive the drugs they need, and because no financial burden would fall
on either the insurance companies or drug providers.
Prior to a drug being approved by the FDA, it must pass through 9 separate phases that all
work to ensure the drugs passed will contain more benefits than risks for users. The first phase
entails the company that created the drug as well as the sponsor show the results of animal
testing and propose the ways in which the drug will be tested on humans. The second phase is an
IND Application, which lists the logistics of the new drugs. During this phase, a panel of
scientists and hospital workers review the drug and approve its clinical trial protocols. The next
three phases are a series of testing procedures that check factors such as side effects,
effectiveness, and overall safety. NDA, or New Drug Application is the final step in the process
of approval. It is the formal step made by the drug sponsor to ask the FDA to approve the drug
for public use. The FDA then has 60 days to decide whether it should be reviewed for further
consideration, or simply thrown out entirely. As you can see, this process is lengthy and does not
accommodate for patients with numbered days. Even some regulations set for the FDA are not
always followed and the rules can often be neglected. Although Congress stipulated that the
FDA must act on new-drug applications within 180 days, staff shortages cause the agency to
often miss its deadlines (Bateman-House). The negligence of the FDA regarding the approval
of new drugs is causing millions of deaths that could be otherwise prevented. Every day
thousands of Americans die unnecessarily from fatal diseases for which lifesaving treatments that
now exist or are being developed are ruled too "dangerous" for commercial distribution (Olsen).

Although the FDA claims that six months for the approval or denial of a drug to pass, it generally
takes more around several years. The Tufts Center for the Study of Drug Development says it
normally takes 5 to 10 years for a drug to receive FDA approval (Ollove). The extensive
approval process is put into place in order to protect the patient, but when death in inevitable
without the drug, it should be the choice of the user whether or not the risk is worth it.
Griffiths, 56, says she is running out of time and would like to try the new ALS treatment: If
Im going to die from this disease, my feeling is, give me a chance, at least (Griffith).
In states that have not yet implemented the Right to Try method, the policy currently in
place regarding the use of experimental drugs is a policy called Compassionate Use. While
this policy does expand the access patients have to utilize drugs not yet approved, it is not nearly
as effective in accommodating patients with limited time as the Right to Try policy is. Along
with being non accommodating to the majority of applicants, the number of Compassionate
Use participants is very limited. Only about 1,000 people make it through the FDAs
compassionate use application process each year (Altman). Another major issue with
Compassionate Use, is even when a patient is approved for it, the policy does not enforce the
fact that drug companies must provide the medication early. Last year, the FDA gave nearly
1,000 people compassionate use approval, but that still doesn't obligate drug companies to
provide medications early (Radcliffe). There are numerous flaws within the Compassionate
Use law that the Right to Try law smooths out. The government allows dying patients to
take experimental drugs under whats called expanded access, or compassionate use, but
Right to Try advocates say the bureaucratic red tape and the waiting period of months and
sometimes years often is longer than the patients life expectancy (FDA.com).

The financial aspect is one that is a major concern for insurance companies, the FDA, and
drug companies alike; no company or organization hopes to take on the burden that is covering
the cost of the risk, as well as the liability regarding the patient. Fortunately, according to the
Right to Try policy, the cost of the development and release of experimental drugs would not
fall onto any of these groups. The bill would not require that drug companies provide the
treatment or that insurance plans cover the costs (Walters). The financial cost of the use and
access to these drugs by patients will instead be endorsed by the Department of Health. This
means that the insurance companies, drug companies, and the FDA all cannot use the fear of
excessive expenses as a reason to not pass the bill. In fact, the passing of the Right to Try
policy doesnt necessarily affect the way manufacturers function at all. This bill does not
mandate manufacturers to provide a drug, nor does it allow them to profit off of providing the
drug to terminally ill patients, he said. Also, it should be noted that federal law already
prohibits the making of a profit off on unapproved drugs (Kacal).
The major concern regarding Right to Try, is the fear that the FDA along with
insurance companies hold regarding potentially being sued by the families of the patients is the
drugs prove to be not only ineffective, but causing the days the have left to be cut even shorter.
Opponents of the approach call it an ill-advised effort that circumvents federal law, that
undermines the drug development process and threatens to harm more people than it
helps by providing access to medications that havent been proven safe and effective (Dennis).
While the issue of suing is one that the FDA as well as insurance companies shouldn't take
lightly, they have no need to have this concern, because under the Right to Try law, the patient
must sign waivers and agreements ensuring that they take full acceptance for all potential side

effects. By doing this, no fault can be placed on anyone other than the patient themselves.
Another controversy surrounding the law is that when a patient is in a fatal state, they tend to be
impulsive and make decisions that could be considered very dangerous for themselves. Patients
who are terminally ill and who are facing less than 1 year of life expectancy are willing to take
greater risks and endure a higher danger of potential adverse effects than other patients, including
taking experimental drugs with unknown risk-benefit ratios (Chen). This claim may be
accurate, but it is also very logical. An impulse mindset is simply the mindset of a human
desperate to hold onto life. These terminally ill patients are simply doing whatever it takes to
extend their survival rate, and although it may be dangerous and could potentially shorten their
lifespan, it is a risk many are happily willing to take.
In conclusion, there are essentially no downfalls to the enactment of the Right to Try
policy being passed and utilized as soon as possible. The risk regarding a terminally ill patients
use of experimental drugs should be between the patient and their doctor, not one made at the
hands of the U.S. Food and Drug Administration. Although liability and financial expenses are
concerning factors, they are minor details when it comes to the life of a human being. By
requiring all 50 states to begin using the Right to Try law, the number of lives saved will
significantly increase. We, as a nation, need to realize the importance of freedom by allowing all
terminally ill patients to freely make the choice regarding the risk they take using experimental
drugs.

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Bibliography:

Altman, Kurt. Facts about Right-to-Try for the Terminally Ill.

www.goldwaterinstitute.com. Goldwater Institute, 13 September 2015
Bateman-House, Alison, Ph. D. "Bioethics.net." Bioethicsnet Blog. N.p., 11 Mar. 2015. Web. 21
Oct. 2015.

Chen, Brian. Right to Try Legislation: Progress or Peril?. jco.ascopubs.org. Journal of

Clinical Oncology, 25 June 2015
Dennis, Brady. Right to Try Laws Spur Debate over Dying Patients Access to Experimental
Drugs. thewashingtonpost.com. The Washington Post. 16 May 2014
Expanded Access: Information for Parents. FDA.com. US Food and Drug
Administration, 31 July 2015
Minor, Malak. States Move to Give Terminally Ill Right-to-Try Drugs.
usatoday.com. USA Today, 19 February 2015
Ollove, Michael. Right-to-try for the Terminally Ill. usatoday.com. USA Today, 19 June 2014

Olsen, Darcy. The Right to Try: How the Federal Government prevents
Americans from getting the Life-Saving Treatments they Need. New York, NY:
Harper. 12 September 2015

Radcliffe, Shawn. Right to Try Movement Wants Terminally Ill to Get

Experimental Drugs. healthline.com. HealthlineNews, 8 June 2015
Walters, Edgar. House Backs Bill Pushing "Right to Try" Experimental Drugs.
texastribune.org. The Texas Tribune. 21 April 2015
Wyatt, Kristen. Colorados Right to Try Law Will Give Some Patients Access to Experimental
Drugs. huffpost.com. Huff Post. 18 May 2014