BY LIFE MATTERS MEDIA STAFF
Former heads of the Food and Drug Administration are urging Congress to scrap so-called “Right to Try” bills that would allow terminally ill patients to experiment with drugs not approved by the agency.
Four former commissioners expressed deep concerns about controversial legislation in the House and Senate.
Former Barack Obama FDA commissioners Robert Califf and Margaret Hamburg, and former George W. Bush commissioners Mark McClellan and Andrew von Eschenbach said the bills would “erode protections” for the most vulnerable.
“There is no evidence that either bill would meaningfully improve access for patients, but both would remove the FDA from the process and create a dangerous precedent that would erode protections for vulnerable patients,” the commissioners said in a joint statement to The Washington Post.
A “Right to Try” bill failed in the House last week after it was brought to the floor under an expedited procedure. With strong Democratic opposition, it failed to garner the two-thirds majority required to pass.
Still, it’s likely the bill will be considered this week under standard procedure that requires only a simple majority.
I am disappointed in House Democrats. Tonight, they voted down Right to Try, a bill I cosponsor, that allows dying people from trying new drugs not yet available on the market. Since 2014, 39 states have approved “Right to Try” laws.
— Rep. Don Bacon (@RepDonBacon) March 13, 2018
A similar bill passed the Senate last summer.
Currently, drug companies allow some patients access to new drugs outside of clinical trials under a program known as compassionate use – as long as the FDA approves such requests.
Although the FDA approves the vast majority of compassionate use requests, sometimes companies refuse, fearing that negative results could be used against them by the government or patients injured by their products.
House Speaker Paul Ryan has expressed strong support for the “Right to Try” bill championed by fellow Wisconsin Republican Sen. Ron Johnson.
“We’re going to move his bill. I’m a big fan of his bill. We’re working on getting it through the House,” Ryan told the Kenosha News last year.
Supporters of such legislation maintain it would make it far easier for seriously and terminally ill patients to access experimental treatments. These vulnerable patients are often unable to participate in clinical trials and have little chance of being cured.
President Donald Trump has signaled support for “Right to Try.”
“The President has made it clear he supports giving terminally ill patients the ‘Right to Try’. I implore my House colleagues to pass S.204 and give the right to hope to so many terminally ill patients in America,” Johnson tweeted Monday.
Remember, right-to-try is an attempt to remove the government and FDA from drug safety and efficacy. We need the FDA to ensure safe and effective drugs. https://t.co/GKOD7MpsVs
— Craig Klugman (@CraigKlugman) March 19, 2018
However, opponents are deeply concerned it would deter patients from seeking hospice care and give them false hope.
“FDA is part of the process for a reason: it protects patients from potentially bad actors or from experimental treatments that might do more harm than good,” Rep. Frank Pallone Jr., D-N.J., the top Democrat on the House Energy and Commerce Committee, said in a statement last week, according to The Hill.
– Image courtesy Pietro Jeng via Pixnio