Due to the lengthy and difficult nature of the FDA’s expanded access program, and inability for all patients to participate in clinical trials of experimental drugs, there was a need to create a channel where terminally ill people could be able to access these drug investigationals that are still being scientifically confirmed safe and effective by FDA. On May 30, 2018, President Trump passed the Right to Try Act federally. Although it follows a similar pattern as legislation in other States, the Federal legislation is significantly different. Patients with life-threatening or terminal diseases are not allowed to have access to experimental drugs. These drugs will not be given to patients whose condition is not suitable for the clinical trial. The law states that drug must have passed phase 1 and been under clinical review. Although it allows terminally ill people to receive investigational drugs from pharmaceutical companies, the law does not make them obligated to do so. The terminally ill patients will have the right to give written consent. Pharma companies will also have to produce a report each year detailing details about the drug, including any adverse reactions.
Trump addressed the State of the Union. He stated that terminally ill people shouldn’t need to travel from one country for treatment. Instead, he wants to offer them the chance to get it right here at home. The Congress should give these amazing, extraordinary Americans the right to try. “The Right to Try will make it possible for many Americans to get treatment for life-threatening illnesses.
There are strong arguments to support Right to Try legislation. Most importantly, patients want the opportunity to live and to access the investigational medications. Patients are informed about the potential side effects and unpredictability of drug use. For those who are unable to participate in clinical trials, the law provides an avenue. Patients must not only be suffering from the disease, but also need to be in a stable condition. This is done in order to test the drug’s safety. If a terminally-ill patient is included in clinical trials and they die within the next few days, it is not possible to predict if the drug has caused death. The majority of patients who are accepted to clinical trials do not get in, so the results may be disappointing for the rest. Children under 18 years old cannot take part in clinical trials, which limits the possibilities of discovering life-saving drugs that could save their lives. These diseases can include life-threatening cancers or the life-threatening Duchenne Muscular Dystrophy.
Second, even if a drug in a trial is approved by the clinical trials for use, it may take months or even years for it to become available on the market. The clinical trials will end and the patients who are critically ill will no longer be able to access the drug after the trial ends. The right to try is a way to ensure that the cure drug is available during the interim phase after completion of clinical trials.
Third, the FDA’s compassionate-use process is not sufficient to help enough people. FDA does approve 99 percent of applications under the compassionate program. However, the FDA doesn’t grant access to investigational drug through the application process. The application process can be complicated, time-consuming, and expensive. Patients have difficulty reaching out to their doctor for treatment drugs because of this. Many lifesaving drugs are currently being approved by the FDA. If you are unable to afford treatment in your country, it is possible to make certain terminal illnesses more accessible to you by acting quickly.
People also argue that the patient has the fundamental right to live a normal life and to have access to treatment if necessary. Individuals should have the freedom to choose their treatment drug, and the State shouldn’t be able to control what people take. Patients should also be allowed to exercise their autonomy as a moral duty. Opponents claim that this law may make it harder for FDA to oversee clinical trials of experimental drugs. The perception that FDA is responsible for drug shortages is false. It is actually the pharmaceutical companies who hold the experimental drugs. There are no laws that require them to submit specimens of untested drugs. Because the FDA is involved in making investigational drugs available for sale, pharmaceutical companies will be more resistant to the Right to Try Act. They don’t speak out because they fear that certain patient groups will be dissatisfied. Due to the high cost and limited supply of experimental drugs, drug companies restrict their availability. They also have concerns about how the drug might affect ongoing clinical trials. They worry about the lack of insurance coverage for experimental treatments. This will limit access to these drugs to only the most wealthy. While Right to Try acts protects companies from potential side effects, pharmaceuticals are still cautious and concerned. FDA is known for saving the lives of millions with fatal drugs. These deaths could have been prevented by FDA in several cases. Additionally, this law can be detrimental to the health of patients by raising hopes about treatment therapies whose effectiveness and safety are still in doubt.
Researchers and doctors are also opposed to the legislation. The dose and method of delivery of drugs is not known or disclosed to the public. If the FDA approves the drug for safety or effectiveness, then the doctors have access to the information necessary for proper care. Blindly using experimental medications can decrease the patient’s lifespan, and may lead to more suffering. Patients have a fundamental legal right to receive treatment. This means that they should be allowed to access the care they need, even if it is with minimal barriers. Right to Try Act aims to protect this fundamental right. The FDA is unable to use the law to address the information gap. FDA approves all marketed drugs as safe. If there is any harm, FDA will not allow it to go to market. FDA puts more effort into thorough testing. This results in delayed approvals, higher recognition and more fiscal investment. FDA can delay or refuse to market the useful drug that could help terminally ill people. This causes patients to suffer, as they don’t have access to potentially lifesaving drugs. FDA officials can cause Type 2 error, which is often not noticed because the drugs have never been tested on real patients. This violates the right of patients to receive treatment. It is essential to find the right balance between providing patients with access to medical investigation and keeping them safe while developing methods to eliminate harmful drugs. The primary goal should be to reduce both Type I-II errors.
FDA’s position is justified, and it should not be compromised. FDA must approve the drug before it is released to patients. Because side effects of these drugs can make a patient’s condition worse, insurance companies will not be able to cover them. In addition, these drugs can be exploited for their medicinal benefits which could cause more harm than good.