Right-to-Try Legislation Passes House, Heads to Trump for Signature

May 22, 2018

Rare Daily Staff

The U. S. House of Representatives passed legislation that would make it easier for terminally ill patients to get access to experimental therapies not yet approved by the U.S. Food and Drug Administration.

Under the law, patients with a life threatening illness who have exhausted all other options can request an experimental therapy currently under study in a clinical trial if they are unable to participate in the trial without going through the FDA. Drug companies can choose not to provide the drug or charge for the cost of providing it.

The so-called Right-to-Try legislation passed with a vote of 250-169. The vote, which was largely partisan, had the support of 22 Democrats.

Though a House version of the bill previously passed in March, to avoid running into problems mustering enough votes in the Senate, the House instead voted on a version that won passage in the Senate in August.

“What it’s trying to do is very simple,” said Senator Ron Johnson, R-Wisconsin, lead sponsor of the bill. “It’s trying to restore freedom. It’s trying to give patients and their families hope.”

The bill is controversial. It had the support of President Donald Trump and conservative and libertarian groups such as Americans for Prosperity and the Goldwater Institute, but was opposed by more than 100 patient organizations, which believed it did not represent an improvement on existing mechanisms and feared it would bypass important safeguards.

The National Organization of Rare Disorders called the version that passed more concerning than the earlier House version because of its lack of patient protections, failure to set a standard for informed consent, its inclusion of a broader definition of eligibility, and weaker reporting requirements.

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

The bill now heads to President Trump for his signature.

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