The bill’s proponents say there is no reason that terminally ill patients shouldn’t have access to experimental therapies if they are willing to accept the risks. | Getty House passes Trump-backed drug bill, letting sick patients bypass FDA 
 
 The House on Tuesday approved a right-to-try drug bill that would allow terminally ill patients nationwide to directly request experimental treatments from drugmakers, a libertarian-inspired effort that captured the personal interest of President Donald Trump and Vice President Mike Pence. 
 
 The bill, which would allow patients to bypass the Food and Drug Administration to make the request for drugs, now goes to the White House, where Trump is expected to sign it. 
 
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 The bill passed 250-169, largely along party lines. 
 
 Critics fear there are not enough patient safeguards in the legislation. House Democrats on Tuesday warned that without FDA oversight, bad actors — such as drug-industry whipping boy Martin Shkreli — would peddle “snake oil” to extremely vulnerable patients with the promise of a cure. 
 
 Trump was a prominent supporter of the right-to-try effort, and his State of the Union call for the legislation propelled the once-stalled bill to his desk. In recent weeks, he personally called lawmakers to encourage them to move forward. Several lawmakers involved in the effort, including Sens. Ron Johnson (R-Wis.) and Lamar Alexander (R-Tenn.) and Rep. Greg Walden (R-Ore.), said the bill likely wouldn’t have passed without his involvement. 
 
 “I can’t tell you how many times I heard in private meetings, ‘Hey, where is right-to-try?’” said Johnson, one of the bill’s authors. 
 
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 The bill’s proponents say there is no reason that terminally ill patients shouldn’t have access to experimental therapies if they are willing to accept the risks. The drugs will have had to go through early-stage safety testing and can be sold at cost. 
 
 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. 
 
 House Democrats on Tuesday largely opposed the measure. 
 
 “Without the FDA, there is no guarantee that what somebody gets as a form of treatment is going to be meaningful and not be harmful,” said Rep. Frank Pallone (D-N.J.). “Once the FDA is out of the picture, there is no way for the patient to know whether the doctor is unscrupulous or whether the manufacturer is unscrupulous.” 
 
 Early versions of right-to-try were drafted by the libertarian Goldwater Institute and enacted in more than three dozen states. ||||| (CNN) With a House of Representatives vote Tuesday, Congress passed legislation that could give terminally ill patients a way to independently seek drugs that are still experimental and not fully approved by the US Food and Drug Administration. 
 
 The House voted 250-169 in favor of the bill, which the Senate passed in August . The bill will now be sent to President Trump, who is expected to sign it. 
 
 "This is an extraordinarily great day," Democratic Sen. Joe Donnelly of Indiana, one of the original cosponsors of the bill, said in a press conference after the event. Donnelly said he met with Vice President Mike Pence a few weeks ago and urged him to push for a House vote on the bill. 
 
 "It is time for the House to do what Senate Democrats won't and send a right-to-try bill to the President's desk, bringing hope to terminally-ill patients across the country," House Energy and Commerce Committee Chairman Greg Walden said in a statement Thursday , when the vote was announced. 
 
 The bill gives terminally ill patients the right to seek drug treatments that remain in clinical trials and "have passed Phase 1 of the Food and Drug Administration's approval process " but have not been fully approved by the FDA. 
 
 Advocates for the legislation say it opens a door for terminally ill people in states that haven't passed such a law. Critics argue that the legislation disempowers the FDA and won't make it easier for terminally ill people to access these drugs. 
 
 Trump has expressed his support for right-to-try legislation and is expected to sign the measure into law. 
 
 "We also believe that patients with terminal conditions should have access to experimental treatments that could potentially save their lives," he said in his 2018 State of the Union address . "It is time for the Congress to give these wonderful Americans the 'right to try.' " 
 
 Frank Mongiello, who was diagnosed with ALS and whose name is one of four on the bill, has been a lead advocate on the issue and was at the Capitol Tuesday for the vote. 
 
 "I think it's the first time I've had butterflies going to the Capitol," Mongiello, who is unable to use his voice, told CNN while using eye-tracking technology. 
 
 "It's very important to me to be able to look my wife and children in the eye and say we did everything possible and say we never gave up," he added. "Unfortunately with today's contentious Congress, I won't really celebrate until after President Trump signs the bill." 
 
 Where's the obstacle? 
 
 "This issue is about real people who are terminally ill, facing the end of the line, and want to have one more shot at life," said Starlee Coleman, senior policy adviser at the Goldwater Institute , a conservative public policy think tank based in Phoenix that supports right-to-try legislation. 
 
 Right-to-try laws exist in 40 states : Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin and Wyoming. 
 
 JUST WATCHED Explaining "Right to Try" legislation Replay More Videos ... MUST WATCH Explaining "Right to Try" legislation 02:56 
 
 With the new federal legislation, Coleman argues, patients in states without these laws could save time accessing experimental treatments by eliminating FDA application requirements. 
 
 "You don't have to file an application with the federal government. You just get to work directly with your doctor and a drug company if you meet the criteria," Coleman said. 
 
 Opponents of the bill, including over 100 patient and provider advocacy groups , say it won't have a major impact on accessing treatments; on the contrary, it could have a detrimental effect on how the FDA safeguards people's health. 
 
 "By removing the FDA oversight, you're counting on physicians and manufacturers to serve as the gatekeeper and protector of our patients. I simply don't buy that that's going to work," New Jersey Rep. Frank Pallone Jr. said on the floor shortly before the vote. 
 
 "The law is ... targeting the wrong obstacle," said Art Caplan , director of the Division of Medical Ethics at the New York University School of Medicine. "It's basically saying the FDA is in the way, and that's why people can't try unapproved medicines." 
 
 "It's companies that control access to their drugs," he added. 
 
 For decades, there have been measures in place for terminally ill patients to access experimental medical products outside clinical trials. These measures are often referred to as expanded-access policies or compassionate use. 
 
 "I'm in favor of pathways that allow patients with terminal disease to get access to products that might be in development," FDA Commissioner Dr. Scott Gottlieb told CNN Chief Medical Correspondent Dr. Sanjay Gupta in April. "That's why we have an expanded-access pathway." 
 
 About 99% of submitted applications for expanded access to almost 9,000 investigational drugs were allowed to proceed over a 10-year period between January 2005 and December 2014, according to a study by FDA researchers, published in the journal Therapeutic Innovation & Regulatory Science in 2016. 
 
 Gottlieb previously said in a statement that "emergency requests for individual patients are usually granted immediately over the phone and non-emergency requests are generally processed within a few days." 
 
 Caplan said, "I think the FDA does fine with compassionate use requests. But let's be clear: FDA doesn't do anything until a doctor goes to a company -- say, a big pharmaceutical company -- and the company says, 'We're going to give you the drug.' If they don't say yes, there is no FDA. So let's be clear where the obstacles are." 
 
 'Flying blind' 
 
 It is unclear how many people have taken advantage of right-to-try laws because the vast majority of states do not have central reporting requirements, Coleman said. 
 
 She also said there's no guarantee that insurance companies would pay for these treatments, and she has seen both outcomes at the state level. The legislation, she said, "is really about giving patients control over the treatments and the options that they have at the end of their life" when they have "exhausted all available treatment options and ... cannot qualify for a clinical trial." 
 
 Some doctors worry that removing the FDA from the equation leaves too much uncertainty surrounding drugs that haven't been tested -- especially when it comes to medically fragile patients taking drugs with unknown risks and benefits. 
 
 "The rest of us doctors are kind of flying blind with respect to things like how much of the drug to give, how to give it, what kind of side effects to look for," Dr. Steven Joffe, professor in medical ethics and health policy at the University of Pennsylvania's Perelman School of Medicine, previously told CNN. "So by cutting the FDA out of the loop, you are failing to take advantage of the knowledge that it has about how to use the drug. 
 
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 "About 10% of the time, the FDA, when it gets requests for expanded access, will say, 'Yes, but here's the way you can do it more safely' or 'here's the side effects to look out for,' " he said, referencing an agency document about patient access to investigational drugs. 
 
 Even the bill's opponents, though, have found some positives about the right-to-try push -- including more data about experimental drugs and greater awareness about other options for the terminally ill. 
 
 "I think the publicity helps and lets more people know 'maybe there's a last ditch thing I ought to pursue,' " Caplan said. 
 
 "But at the end of the day, creating a world in which you say there's a right to try, if it's nothing more than a right to beg a company, that right already exists, and you're really not doing much to help anybody gain access to much of anything."
– A "right-to-try" bill that allows terminally ill patients to request medication that hasn't been approved by the Food and Drug Administration has passed Congress and is expected to be signed by President Trump. The bill, which passed the Senate last August, sailed through the House Tuesday with a 250-169 vote, largely along party lines. Democratic Sen. Joe Donnelly called it an "extraordinarily great day," CNN reports. Starlee Coleman of the conservative Goldwater Institute says the bill will make it easier for people in 10 states without right-to-try laws to access new treatments. "You don't have to file an application with the federal government," she says. "You just get to work directly with your doctor and a drug company if you meet the criteria." Trump and Mike Pence took a personal interest in the bill, with Trump saying during his State of the Union address that his administration believes "patients with terminal conditions should have access to experimental treatments that could potentially save their lives." House Democrats, however, warned that removing safeguards could lead to people like Martin Shkreli ripping off vulnerable patients with "snake oil" cures, Politico reports. "By removing the FDA oversight, you're counting on physicians and manufacturers to serve as the gatekeeper and protector of our patients," said New Jersey Rep. Frank Pallone Jr. "I simply don't buy that that's going to work." Other critics of the bill say it's generally drug companies, not the FDA, that block people from trying unapproved medicines.