The Right-To-Try Bill Puts Patients At Risk In The Name Of Helping Them | HuffPost

"Congress recently approved the federal right-to-try bill after a months-long standoff in the House, and President Donald Trump signed it into law on Wednesday. The measure allows people with life-threatening diseases to bypass the Food and Drug Administration to obtain experimental drugs.

The right-to-try movement is nothing if not well-intentioned, inspired by high-profile patient cases ― mostly desperately ill children ― whose stories struck a nerve with the nation. Much of the public, enamored by the undeniable surface-level appeal of right-to-try legislation, embraced this movement. But those with a deeper understanding of the drug development process ― medical professionals, ethicists and regulators ― have been publicly skeptical. 

The truth is this legislation will do almost nothing to help terminally ill patients. That’s because the entire right-to-try approach is based on a myth: that the FDA is the rate-limiting middleman preventing patients from receiving potentially life-saving drugs. 

Over the last four years, right-to-try legislation has gained momentum and is already the law in 40 states. The laws grant terminally ill patients who have exhausted other treatment options the right to request access to potentially life-saving drugs that have cleared Phase I clinical trials without approval or oversight by the FDA. ...

The reality is, the real gatekeepers to expedited access ― as Josh Hardy’s family encountered ― are pharmaceutical companies. And this new right-to-try bill does nothing to compel manufacturers to grant patients access to experimental drugs. 

In a meager attempt to nudge companies to authorize more compassionate use cases, the federal right-to-try bill offers companies immunity from legal recourse should drug-related adverse events occur. It also prohibits the FDA from considering these events during its approval process....

But right-to-try legislation isn’t just superfluous ― it may also create a new type of inequality among the terminally ill. To rally drug companies to provide experimental therapies, patients and their families often need to be well-connected, relatively affluent or adept at navigating social media to put drug companies under pressure. Those without the resources or know-how may never receive access to experimental therapies...."