A new law, the Right to Try Act is allowing terminally ill patients to try experimental therapies or drugs that are generally not approved by the Food and Drug Administration (FDA). The new law states that eligible patients can use the drugs that are currently the subject of an active FDA application or in other cases are undergoing clinical trials. But the patients have to be eligible to get access to the drugs. The patient should be diagnosed with a disease or any severe condition that can be fatal or can cause premature death.
Previously, many states had existing laws that allowed certain patients to have access to experimental treatments. The FDA already had a pathway in place with which it used to grant expedited access to experimental drug treatments for patients suffering from terminal illnesses. However, it is a fact that only 3% of terminally ill patients could gain access to experimental drug treatments. This new act has been passed solely to increase these numbers and in the process check the authenticity of potential therapies and drugs.
Before the enactment of the Right to Try Act, concerns were raised regarding the safety of the patients, and the bill was stalled in the House. In the due course of time an updated version of the bill was introduced that added additional patient protections, and thus the bill was passed.
Biotechnology and pharmaceutical companies have started preparing for the compliance requirements that this legislation brings to the table. Although the details of the requirements are not made public as of now, some of the requirements include annual reporting to the FDA about a patient receiving an unapproved drug and real-time reporting of events.
The Act also requires the FDA to update reports on the website about the use of drugs as reported by the manufacturers. The regulations and rules of the act may keep changing with the coming time, but the Act is sure to bring additional compliance and reporting requirements to pharmaceutical and biotech companies.