Doris Matsui: “This proposed ``Right to Try'' legislation will make it possible for bad actors to take advantage of desperate families.…”

“This proposed ``Right to Try'' legislation will make it possible for bad actors to take advantage of desperate families. The pill would allow companies to completely circumvent the FDA if they claim to have a new drug or cure for a patient. And it dogs not require the doctor or the company to even report to FDA, so we will have no way of knowing who is trying which experimental drug. This legislation really does encourage snake oil salesmen. Currently, legitimate companies may have new experimental drugs that have not yet been approved, but that could be helpful for patients who have no other options . . . but this bill is not limited to that situation. And, FDA does have an existing process to allow for patients with life-threatening conditions to try experimental drugs before they are approved. And, this bill is not limited only to patients with a life- threatening condition. FDA has testified that the process under this bill would be available much more broadly to patients with chronic conditions such as diabetes. That is a large population with a condition that is managed with currently available treatments. Under this bill, bad actors could see the dollar signs to market ineffective drugs to these patients. The bill before us today does not require FDA or Institutional Review Boards (or IRB's) to review any request for experimental therapy, and rescinds any requirement to report adverse effects of a drug immediately.…”