According to a post from the National Organization of Rare Disorders, the organization has joined thirty-seven other patient and provider groups and organizations in opposition to the “Right to Try” bill that was introduced in the House of Representatives. The group sent a letter to the governing body explaining their position on the bill.
The Right to Try Act that has been circulating in Congress appears to also have the support of the White House. Similar types of legislation have been enacted on multiple occasions on the state level. The bill, in theory, intends to make it easier for patients with terminal or severe illness to access investigational or experimental treatments that are not available to the general public. Currently, there is a path to access for these experimental treatments already. Under present law, the FDA must approve the usage of investigational drugs outside of the clinical trial setting, but the new bill would circumvent this process entirely.
The legislation was heavily supported by anti-regulation, libertarian organizations, and suggests that the FDA is preventing people from accessing these experimental medications in a timely manner. However, records indicate that the FDA approves over 99 percent of access requests, and the agency doesn’t get involved until after the drug company has already expressed interest in providing its product. Most of the time, the drug companies are responsible for denying requests. Critics of the legislation fear getting the FDA out of the picture may in fact cause more harm than good.
It is possible, without review by the FDA, doctors and patients do not have adequate understanding of the risks of trying the experimental drug or how the treatment is supposed to work. Removing this review process could allow drug companies to profit from distributing drugs that could actually cause harm to patients. Meanwhile, companies that are hoping to ultimately obtain FDA approval for their products may become more hesitant to provide experimental treatments; if something goes wrong outside of clinical trials, the likelihood of approval gets much worse.
Many believe the legislation as it stands has little chance of actually helping improve access to investigational treatments. In fact, there is concern that this bill increases the likelihood of severely ill people getting exploited or harmed even more. While there may be a need for greater access to these drugs, this approach is not without controversy.
