Sending Office: Honorable Gene Green
Former FDA Commissioners and Officials Oppose “Right to Try” Legislation
Today the House will vote on the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018. This controversial “Right to Try” legislation bypassed the Committee process and will be introduced and considered
today in the House.
“Right to Try” is based on the false perception that the Food and Drug Administration (FDA) is a barrier to patients accessing experimental treatments. However current FDA Commissioner Scott Gottlieb has rejected this notion.
“There is a perception that certain products that aren’t being offered under FDA expanded access … will be offered under right-to-try,” Commissioner Scott Gottlieb told the House Energy and Commerce Committee in October. “I don’t
Gottlieb, who homed in on the barriers drug companies have to providing experimental medicines, also emphasized that the vast majority of drugs provided to patients through its compassionate use program turn out to be ineffective. “We know that 70 percent
of all drugs that are offered under an expanded access setting are never approved by FDA,”Gottlieb said.
[Source: Politico, 03/12/18]
FDA has a long history of facilitating patient access to experimental treatments. For the past five years FDA’s approval rate for expanded access requests has been over 99 percent. FDA physicians are even available 24 hours a day to approve any emergency
expanded access requests the agency receives—typically granting emergency requests immediately over the phone and non-emergency requests in a median time of four days and generally no longer than 30 days. Furthermore, FDA review of expanded access plays a
critical role in patient safety. In 11 percent of expanded access applications FDA has recommended changes to protect patients before allowing the treatment to proceed, including adjusting dosing amounts, strengthening informed consent, or increasing safety
Both of FDA Commissioner Gottlieb’s immediate predecessors have also come out opposing “right to try” raising concerns that excluding FDA review could pose serious risks to patients.
“I am deeply concerned by the draft legislation being considered by the Senate and House to remove the FDA from the proposals around right to try.”
“Excluding the FDA will not benefit those patients and would be a mistake. There is no need to create a new, potentially dangerous paradigm by passing this legislation, which does not address the real issues at hand and could have
unintended negative consequences leading to a possible impediment of the development and approval of safe and effective therapies.”
[Source: Dr. Margaret Hamburg]
“FDA review allows doctors and patients to tell the difference between a medication that works and one that does not. Evidence also orients the pharmaceutical market toward developing products that produce meaningful benefits for
patients instead of just hype. Undermining FDA review by giving a right to patients to try anything at any time will leave many more patients in desperate situations, with fewer options and less understanding of what could really make a difference.”
[Source: Former FDA Principal Deputy Commissioner Joshua Sharfstein]
“Right to Try” offers false hope to patients, as the legislation under consideration does not require companies to provide experimental treatments to patients who request them. While 38 States have enacted “right-to-try” laws, there is no evidence that
a terminally ill patient has received access to an experimental drug through such a pathway. Pharmaceutical companies may choose to deny a patient access to an experimental treatment because, for example, there is not enough of the drug available or they are
concerned about dangerous side effects. The fact is when a patient is denied access to an experimental treatment it’s because the company has said no, not the FDA.
Former FDA Commissioner Robert Califf said he worries any right-to-try law will set patients up for disappointment. “What it may do is to raise expectations of vulnerable people and their families that there is some miracle cure that is going to be made
Even if more companies release products under right-to-try — a prospect Califf thinks is doubtful — the odds for helping patients are long. That’s because most promising new drugs end up being too dangerous or simply don’t work.
[Source: Politico, 03/12/18]
I urge you to heed these warnings of former FDA Commissioners and experts about the dangerous precedent and risk that this legislation poses to patients. Please vote NO on
Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018.
Member of Congress
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