Right to Try Laws and Access to Experimental Drugs
Right to try laws allow terminally ill patients to use investigational treatments, including experimental drugs that aren't available to the general public and haven't been fully approved by the U.S. Food and Drug Administration (FDA).
To illustrate how this plays out, imagine that you've been diagnosed with a terminal disease. Having exhausted conventional treatment options, you're interested in something more experimental, but you can't enroll in a clinical trial because you're too sick to qualify. One option is to apply to the FDA's Expanded Use Program. The other alternative is to bypass the FDA and work with your physician to approach drug manufacturers directly to gain access to experimental drugs via right to try laws.
History of Right to Try Laws
Colorado was the first state to pass a right to try law in 2014, with many other states eventually following suit. It began with patients and their advocates who were frustrated by the lack of access to experimental drugs with potential life-saving qualities. They had to wait for the drugs to be approved by the FDA's process that involves three phases of testing; this typically takes many years before the drugs are available.
Federal and State Right to Try Laws
The opportunity for all Americans to have an opportunity to take drugs that could save their lives was cited as a reason for the need of federal right to try legislation. In January 2017, a bill was introduced in the Senate and, after going through multiple versions, a bill was passed and ultimately signed into law by President Trump on May 30, 2018.
Among other things, the federal Right to Try law:
- Allows terminally ill patients who can't participate in clinical trials and who have exhausted all approved treatment options to use unapproved experimental drugs;
- Requires that any drugs used must still go through FDA Phase I testing; and
- Limits the liability of drug sponsors, manufacturers, prescribers, or dispensers that provide or decline to provide an eligible drug to an eligible patient.
Most states have right to try laws as well, but there are key differences between the state versions and the federal law. For instance, California's law only covers those patients that have months to live, in contrast to the more broad "terminally ill patients" who are eligible under federal law.
A major similarity between state laws and the federal law is that there isn't any guarantee of access to the drugs. There are no mandates that compel drug manufacturers to give the drugs to the patients; it's strictly based on their choice and many times the manufacturers are unwilling to participate.
There are numerous reasons why drug companies wouldn't want to provide unproven and experimental drugs to patients. Because these laws cover drugs in the FDA's Phase I (which only states that the drug is relatively safe for humans), patients can experience bad reactions and side effects that are often discovered in the later phases of testing. This can make it less likely for the drug to be approved later down the road.
Additionally, this brings up potential liability issues mainly related to state laws because the federal legislation significantly reduces the liability of drug manufactures.
Concerns With Right to Try Laws
Extending liability protection to manufacturers is just one of many concerns that stem from right to try laws. While supporters of the laws view them as an efficient way for dying patients to get drugs that could save their lives, some opponents perceive the laws as unnecessary and harmful to patients.
Advocates for these laws believe that bypassing the FDA ensures patients a quicker path to accessing experimental drugs when they don't have time to spare. Supporters also claim that the similar FDA Compassionate Use (Expanded Access) program that grants non-clinical trial patients access to experimental drugs is too complicated and time-consuming.
However, critics argue that these laws can be too risky for already sick patients because the drugs they cover don't have the same safeguards that are in place with the Expanded Use program and because the laws undermine the FDA, the agency which is supposed to protect the public from harmful substances. They also point out that patients can lose opportunities for hospice and home care under some state right to try laws.
Want More Information on Right to Try Laws? An Attorney Can Help
If gaining access to experimental drugs and treatments is a concern for you or someone you know, then you're likely already dealing with some difficult life challenges. If you need more information about right to try laws, then get clarity and peace of mind by talking to an experienced health care law attorney today.