"Right to Try" Bill Heads to President Trump for Approval

This Tuesday, Congress voted to pass legislation referred to as the right-to-try bill which will provide terminally ill patients with the ability to seek out experimental therapies not yet approved by the US Food and Drug Administration (FDA).

The vote comes just 9 months after the US Senate voted to do the same. Now, the bill is headed to President Trump for final approval. As the president has repeatedly professed support for the potential new law in the past, most recently in his State of Union address, the bill is likely to be approved.

“We believe that patients with terminal conditions should have access to experimental treatments that could potentially save their lives,” the President said in the address. “It is time for Congress to give these wonderful Americans the ‘right to try.’”

Although the bill will allow for patients to seek out these therapies, pharmaceutical companies are not required to provide them to patients. Furthermore, if they do choose to provide them to patients, the bill does not prevent them from charging patients to use the therapies.

The National Organizations for Rare Diseases (NORD) released a statement today, May 23, 2018, professing their disappointment in the vote made by the House of Representatives.

“We have strongly opposed all Right to Try legislation, as we do not believe that it will safely and genuinely increase access to investigational therapies outside of clinical trials,” the statement reads. “Unfortunately, this version of Right to Try, S.2014, is particularly concerning.”

They list the following reasons for their concerns, stating that S.204:

• Is devoid of all patient protections that the House version of Right to Try, H.R.5247, added
• Does not provide a standard for informed consent
• Has a really broad definition of eligibility
• Contains vastly weaker reporting requirements

“Thus, not only will this legislation be ineffective, as all Tight to Try laws are, it will also present a danger to many patients we represent,” they added.

Last week, FDA commissioner Scott Gottlieb, MD, noted that this version of the bill would make things more challenging for the FDA, when it comes to supervision and regulation. In fact, he told STAT News that the original version had contained aspects that would have potentially allowed for more patient defenses and allowed for a little more leeway for the FDA to implement the law.

The FDA’s expanded access program already provides patients with access to experimental therapies, NORD argues in their statement, with priority being first and foremost, patient safety.

“The bill that passed the House today is dangerous,” the statement concludes, “and we will do everything we can to protect our patients from unsafe and ineffective therapies.”

Currently, right-to-try laws exist in 40 states with only Alaska, Delaware, Hawaii, Kansas, Massachusetts, New Jersey, New Mexico, New York, Rhode Island, and Vermont, excluded.

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