On Thursday of last week, the US Senate passed a bill intended to improve treatment access for the country’s sickest patients. The Trickett Wendler Right to Try Act of 2017 passed by unanimous consent and will now move on to the House of Representative for review.
If approved and signed into law, the Right to Try bill will prevent the FDA from overseeing and regulating patient access to investigational new drugs. By removing this government intervention, Right to Try will allow patients to use unapproved medications after (a) receiving a prescription from their treating physician and (b) gaining approval to use the product from the drug manufacturer. Theoretically, this means that patients will have one less hurdle to jump through when trying to access important drugs that could help save their lives.
The bill has clear stipulations in place to protect both the health of the patients and the interests of the drug companies:
- In order to be eligible for Right to Try, patients must have exhausted all other possible treatment options. This means patients must have tried any and all approved medications and must also be ineligible for any FDA-approved clinical trial.
- Drugs used under Right to Try must have passed phase 1 clinical trial and must still be under investigation in a later-stage clinical trial. Right to Try will not work for pre-clinical drugs nor will it work for any FDA-approved medications.
- Drug companies will have no liability regarding the use of their medications. Providing products through Right to Try must not affect how drug companies’ products are reviewed for approval by the FDA. Any negative or adverse events reported by physicians will only be put forward to the FDA for consideration if the information is critical to determining whether a product meets the FDA safety standards.
Visit the congress.gov website to find out more about the specifics of this bill.
Supporters of the bill believe Right to Try represents a humanitarian effort to provide hope to desperate patients who have no treatments available to them. According to Senator Ron Johnson, who wrote the bill, “Patients with terminal diseases ought to have a right to access treatments that have demonstrated a level of safety and could potentially save their lives,”.
Similar sentiments have also been expressed by both President Donald Trump and Vice President Mike Pence. During his time as governor of Indiana, Pence was responsible for the passing of state Right to Try legislation. To-date, 36 other states have approved similar state-level Right to Try laws. Pence believes that creating national Right to Try legislation will help patients living in those states without state laws, and will prevent the FDA from superseding state laws where they currently exist.
However, not everyone is in favor of this new bill. There are skeptics within the industry who argue that Right to Try is unnecessary given that the FDA does a good job of allowing seriously sick patients to access unapproved medications. Through the FDA-regulated Expanded Access mechanism, the agency approves around 99% of the requests it receives and responds to requests in a matter of days. As such, there is little evidence to suggest that the current system is ineffective or unsuitable.
If anything, the real issue for patients is getting drug companies to agree to provide their products. The Trickett Wendler Right to Try Act does attempt to decrease the risk associated with providing unapproved medication outside of the clinical trial setting by stating that any negative adverse responses reported will not affect a company’s chances of receiving FDA-approval for its products. However, there are a multitude of other reasons companies decide not to provide access to their experimental drugs, and it is not yet clear if or how this new bill would address these concerns.
Furthermore, many worry that this bill could open up patients to increased risk. Because the Right to Try bill leaves the decision making to the physician and the drug company, patients could fall victim to fraud or abuse. Physicians often form relationships with drug companies, and without federal oversight, a doctor could be coerced by a drug company into prescribing its product over another more suitable drug.
However, it may be some time before we find out which viewpoint the House decides to favor when casting its vote. As it stands, the top health care priority seems to be deciding if and how to replace or repeal Obamacare, so this Right to Try legislation will most likely take a back seat for the time being.