The House of Representatives of the American Congress adopted a bill for the second time. According to this bill patients with incurable diseases will be able to receive experimental medications. Now, the bill “right to try” requires the approval of the Senate, which created its own document in 2017.
According to the bill principles, incurable patients who cannot take part in clinical trials, and who have not been helped by other therapy, will be able to receive experimental drugs. However, the bill does not oblige pharmaceutical companies to provide patients with such drugs at request.
The bill also protects pharmaceutical manufacturers, doctors, and hospitals from various legal risks associated with the unapproved drugs use. Doctors and hospitals will be exempted from liability if their actions lack criminal elements.
Supporters of the bill believe that it will provide Americans, who have incurable diseases, with access to potentially effective drugs. However, opponents believe that this bill will weaken the supervision of the FDA and, if it will be approved, the pharmaceutical companies will promote drugs with unproven efficiency and safety.
Scott Gottlieb believes that there is no need to adopt such law, as in the United States there is a program “compassionate use”, which in fact duplicates the law “right to try”. The only difference is that the patient can get an unregistered drug after the approval of the expert council. In recent years, the FDA has approved 99.4% of applications from patients.
According to Gottlieb, the main obstacle to the functioning of the law will be the lack of access to experimental drugs, as some farm companies do not have enough resources to support demand. And, no less important, pharmaceutical manufacturers will find it more difficult to recruit participants for clinical trials.