Four former commissioners of the Food and Drug Administration are expressing opposition to congressional “right to try” legislation, just as Republican House leaders prepare to bring a bill up for another vote a week after it failed to pass.

The legislation is designed to allow seriously ill patients to bypass the FDA to get access to experimental treatments. The former agency commissioners, in a joint statement provided to The Washington Post, criticize both House and Senate proposals.

“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,” they say.

The Senate passed a right-to-try measure in the summer. The House version, which is different in several aspects, was brought up last week under an expedited procedure. In the face of staunch Democratic opposition, it failed to muster the two-thirds majority required to pass. This week, the bill will be considered under standard procedure that requires only a simple majority, or 218 votes, and approval seems certain.

The statement by the former FDA heads was signed by Robert Califf and Margaret Hamburg, who were commissioners during the Obama administration, and Mark McClellan and Andrew von Eschenbach, who served under George W. Bush. Some have previously expressed reservations individually about the bills. The joint statement is a show of bipartisan unity to try to slow the legislation’s progress on Capitol Hill.

GOP lawmakers say right-to-try bills, which are strongly backed by President Trump and Vice President Pence, would give desperately ill patients a last chance at survival. Democrats say the measures would skirt FDA rules designed to protect patients without addressing basic obstacles to accessing experimental medications. Drug companies, for example, often are reluctant to provide experimental therapies outside of clinical trials, and the federal right-to-try legislation would not compel them to do so.

Critics also note that the FDA already has an expanded-access program for approving experimental drugs for patients who are not in clinical trials. The program receives more than 1,000 requests a year and approves 99 percent, according to the agency.

The House and Senate bills are designed to give patients access to medications that have undergone only preliminary testing in humans. Patients would have to be ineligible for clinical trials and first try all other available treatments.

The legislation has been championed by the libertarian Goldwater Institute, which has worked to pass similar laws in 38 states. But last week, more than 75 patient groups, including the American Cancer Society Cancer Action Network, the American Lung Association and the Cystic Fibrosis Foundation, sent a letter to House leaders opposing it.

“This bill, at minimum, would create false hope for dying patients. At its worst, it would cause serious harm to the most vulnerable,” said Ellen Sigal, the chair of Friends of Cancer Research.

The House Rules Committee is scheduled to consider the right-to-try bill Monday, with a floor vote expected Tuesday or Wednesday. Because the House and Senate bills are different, the Senate either would have to consider the House bill, if it passes, or the two measures would have to be reconciled in a conference committee.

The Senate bill, for example, defines eligible patients as those with a “life-threatening disease or condition.” The House narrowed that eligibility, saying patients could participate only if they are likely to die in a “matter of months” or have a disease that would result in “significant irreversible morbidity that is likely to lead to severely premature death.”

Republican committee aides have said the House legislation includes stronger informed-consent requirements and would require doctors to immediately notify the FDA about adverse events, something the Senate legislation does not address. Under both chambers’ bills,  the FDA could consider adverse events as part of a drug-approval review, but only if such complications are “critical to determining the safety” of the drug.

https://www.washingtonpost.com/news/to-your-health/wp/2018/03/18/former…