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A bill helping people with deadly diseases try experimental treatments sailed through Congress on Tuesday, a victory for President Donald Trump and foes of regulation and a defeat for patients' groups and Democrats who argued the measure was dangerous and dangled false hope. After an emotional debate, the House gave the legislation final congressional approval by a largely party-line vote of 250-169, nine months after it passed the Senate. (Fram, 5/22)

The bill would, in effect, allow dying patients to bypass the Food and Drug Administration and obtain an “investigational drug” with the approval of their doctors, if the drug manufacturer agrees to supply it. On at least three occasions in the past four months, Mr. Trump has urged Congress to pass the bill.“Patients with terminal conditions, and terminal illness, should have access to experimental treatment immediately” and “should not have to go from country to country to seek a cure,” he said in January in his State of the Union address. (Pear, 5/22)

The Senate passed the bill in August, and the House approved its own version in March. That version was less objectionable to the medical groups, but then the legislation got bogged down. With the White House demanding action, House leaders in recent days decided to short-circuit the process by taking up the Senate-passed bill. The vote was 250 to 169. The measure, championed by Sen. Ron Johnson (R-Wis.), is designed to give patients an alternative way to obtain drugs not approved by the FDA. Currently, there are two options for patients seeking experimental medications: enrolling in clinical trials if they are eligible or participating in the FDA’s “expanded access” program. The agency has said that it approves almost all such requests to that program. (McGinley, 5/22)

Most patients already get access to unproven medicines under a compassionate-use program overseen by the Food and Drug Administration, agency officials say. But the bill would essentially skirt the FDA’s normal approval process to get trial medicines more rapidly to patients with life-threatening illnesses. Republicans pushed for the change, which Mr. Trump supported in his State of the Union address, saying it would give patients access to non-FDA-approved drugs before it is too late. Some Democrats and patient groups have argued it would usurp the FDA and leave patients vulnerable to dangerous and possibly sham treatments. (Armour, 5/22)

Trump heard from Pence — who had passed a similar bill while governor of Indiana — many anecdotes about terminally ill people and their families who wanted access to new drugs, according to an administration source. The legislation took a winding path through Congress. The vote Tuesday was the third time the House attempted to pass a right-to-try measure, having failed once to get enough votes to fast-track the bill. The effort also got caught up in a standoff between the House and Senate, which had competing versions of the bill. Patient advocacy groups that opposed the bill’s passage this week didn’t raise much opposition when the bill quietly passed the Senate unanimously last year. A last-ditch effort to get a new version through the Senate in recent days failed. (Haberkorn, 5/22)

FDA Commissioner Scott Gottlieb said on Twitter that he's "comfortable" with the bill and later that he is prepared to implement the law "in a way that achieves Congress' intent to promote access and protect patients." (Kodjak, 5/22)

Twenty-two Democrats broke ranks to join Republicans in supporting the bill which lets patients bypass the Food and Drug Administration (FDA) when they request access to drugs the agency hasn’t yet approved. (Roubein, 5/22)

The bill’s passage is a win for conservative and libertarian groups like the Koch-brothers-backed Americans for Prosperity and the Goldwater Institute. It is also the conclusion of a surprisingly and increasingly political saga that pitted those groups against many House Democrats, some drug makers, patient groups, and medical ethicists. Key House Republicans and former FDA commissioners have all raised concerns with the legislation, as has current FDA Commissioner Scott Gottlieb, though he remains supportive of the bill. (Mershon, 5/22)