In 2015, Mike Pence who was Indiana governor at that time signed a measure similar to this one. This proposed legislation is awaiting House of Representatives vote which will be done this month. Donnelly hopes that the house will consider it. The bill will offer legal protection to drug companies should the treatment lead to harm. Sen. Ron Johnson said that patients terminal ill patients should have a right to try treatments that can save their life and have shown some level of safety.
Some critics, however, said that the bill is unnecessary and inherently deceptive since patients can just ask for treatment from drug companies. Companies usually don’t want to offer unapproved products for several reasons. However, the FDA has a system in place to handle any request for an experimental drug.
The earlier version of this measure prevented the FDA from using safety problem information to approve drugs under this legislation. In the latest measure, agencies are allowed to consider safety information when it is crucial to determine if a drug meet the safety standards of the agency. The legislation requires the FDA to speed up generic drug application for those drugs with no or little competition. Also, a provision is in place to increase approved cancer treatments for children. The agency authority directs those working on oncology therapies to test them in children.