The FDA approved drugs are having safety and efficacy confirmation for the intended use. But getting approval from the FDA is time taking process. But the FDA permits to market of some of the unapproved drugs in the following cases:
- the medication is tested under the drug efficacy study implementation program, or
- healthcare professional convinces the agency members to allow to treat serious medical conditions when no FDA approved medications are available in the market to treat the condition, or
- inadequate supply of FDA-approved medication.
The investigational drugs for cancer treatment can be accessible in three ways, which are:
- By taking part in a clinical trial
- Expanded access
- Right to try
Clinical Trials
Participating in clinical trials is one of the preferred ways to get access to experimental drugs to treat cancer. Clinical trials are well designed by medical research experts. Patients who participate in a clinical trial are fully informed about the treatment and closely monitored. During the research, the data are collected by checking the different parameters of the patient’s health to conclude the safety and efficacy of the researched medication. But to participate in clinical trials, patients have to meet the eligibility criteria for taking part in the research study.
Expanded Access (Compassionate Use)
Expanded access or compassionate use are regulated by the FDA. In this process, the patient can get the experimental medication without taking part in a clinical trial for treating life-threatening diseases like cancer or other serious illness. To get permission for expanded use following criteria is necessary:
- A patient diagnosed with a life-threatening illness
- No availability of standard medication
- Not eligible for a clinical trial
How to Obtain a cancer medication through Expanded Access?
Only your doctor will help you to get medication through expanded access. Doctor needs to
- Directly contact the company that develops and tests the experimental drugs. In most of the cases company usually not readily allow to give the medication in such special permission also, as the dosing of the drug is not established or for insufficient stock.
- The doctor needs to directly contact the FDA for getting permission for expanded access to the medication.
Right to Try
Right to Try is similar to expanded access, which means the patient needs not to participate in the clinical trial. But this process is not regulated by the FDA. Following are the criteria requirements for applying the right to try:
- The patient has a life-threatening illness
- No availability of standard medication
- Not eligible for a clinical trial
The medications also should maintain the criteria:
The phase of a clinical trial of the medication has been completed
The FDA does not approve any use of the applied medication
The Company which has the patent for the medication has already applied for the FDA approval, or clinical trial is continued and completion of different phases will be seeking drug approval.
How to Obtain a cancer medication through Right to Try?
Only your doctor will help you to get medication through expanded access. The doctor needs to directly contact the company that develop and test the experimental drugs and checks
- The drug is suitable to apply for the right to try
- The pharma company is willing to provide the medication without any obligation.
References:
https://www.fda.gov/drugs/enforcement-activities-fda/unapproved-drugs
https://www.cancer.gov/about-cancer/treatment/drugs/access-experimental
