On Tuesday, the House of Representatives saw the derailing of legislation that would have given persons facing life-threatening illnesses to right to seek as yet unproven experimental treatments. Considered under fast-track legislative procedures that required a two-thirds majority for approval, the bill was rebuffed. Normally, the procedure is used for otherwise non-controversial legislation. However, the measure fired up passions in the House. In the end, 259 House members voted in favor, while 140 were opposed. Most of those opposed are Democrats.
Democrats claim that the bill gave but false hope to sufferers and merely endanger those facing terminal illness, arguing that it would second-guess protections already in place and administered by the Food and Drug Administration. Rep. Frank Pallone Jr. (D-NJ), the ranking Democrat on the Energy and Commerce Committee, stated, “By defeating this bill tonight, we protected patients and supported F.D.A.’s continued role in approving experimental treatments that may help save a patient’s life.” He added, “This bill should have never been on the House floor in the first place since it was only introduced today.”
According to OpenSecrets.org, Pallone received $105,500 in contributions from PAC related to the health professions, and another $79,150 from pharmaceutical PACS in 2017-2018.
Commerce Committee Chairman Greg Walden (R-Ore.) and Health Subcommittee Chairman Michael C. Burgess (R-Tex.) were disappointed with the failure of HR-878 to pass. “For months we sought to strike the right balance by allowing patients greater access to these unapproved treatments and therapies while also ensuring proper patient protections,” they said in a joint statement. “This bill does just that.”
With support from President Donald Trump, the Senate passed a similar bill last year. Rep. Kevin McCarthy (R-Calif.), the House Republican whip, signaled that the bill may not be dead. “We will try again, pass legislation and bring hope to those whose only desire is the right to try to live,” he said. Under House rules, the measure can get another vote that allows passage with a simple majority. In his State of the Union address in January, Trump said, “People who are terminally ill should not have to go from country to country to seek a cure,” he said. “I want to give them a chance right here at home. It’s time for Congress to give these wonderful, incredible Americans the right to try.”
On Tuesday, supporters of the bill appeared confident that it could pass. “Our bill will give some relief to terminally ill patients who have no further options left to extend their lives,” said Representative Andy Biggs (R-Ariz.), who introduced the bill. In Arizona, a similar measure garnered 78 percent of the vote in a 2014 referendum. “All Americans have the right and freedom to try to save their lives.”
According to the New York Times, Dr. Robert M. Califf, who served as the Obama administration’s Food and Drug Administration director, said, “Supporters of this legislation talk as if effective treatments are being withheld from patients,” adding that he believes that the majority of experimental treatments are toxic and ineffective. Also opposed was the American Cancer Society and various advocacy groups. Also opposed were the American Medical Association and the American Society of Clinical Oncology.
Advocates for the pharmaceutical industry -- the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization — have not taken a position on the bill.
Under the provisions of the failed House bill, patients must be shown to have a life-threatening illness that is likely to cause death “within a matter of months” or “irreversible morbidity that is likely to lead to severely premature death.” After the patients provide informed consent in writing, the manufacturer would notify the government within seven business days of providing the drug to a physician for a patient’s use. Also, the doctor must report “serious adverse events” to the drug manufacturer. .
Pharmaceutical companies, doctors and hospitals would be shielded by the bill from some of the legal risks of providing non-approved medications. Unless doctors and hospitals engaged in gross negligence or willful, reckless or criminal misconduct, or intentional harm of a patient, they would generally be protect. Also, the bill would not require pharmaceutical companies to provide experimental medications to patients who want them, while allowing the companies to refuse requests for a variety of reasons, including, for example, if they have a limited supply of a drug that must be used in clinical trials.
Victor Riches, president of the Goldwater Institute, which was in favor of the legislation, expressed disappointment at its failure in the House. In a release, he said, “Unfortunately, scare tactics, falsehoods, and innuendo won the day. We are extremely disappointed that some members of Congress chose to make this bipartisan grassroots movement partisan.” He added, “Thirty-eight states now protect your Right to Try, and a similar law awaits the signature of Wisconsin’s governor. Cancer patients from across the country are alive only because they could access life-saving medicine through the Right to Try as protected by those states, not by Washington. This effort is not over.”
In 2015, Timothy Terrell of the libertarian Mises Institute wrote:
- “The American public tends to think of the FDA as a protector against dangerous side effects, as we saw with Thalidomide decades ago. But how many Americans have died because of lags in approval? A five-year delay in bringing the antibiotic Septra to the US market may have cost 80,000 lives. A lag in the approval of beta blockers may have cost 250,000 lives.1 The FDA's ban on advertising aspirin as an effective preventer of first heart attacks may have caused the deaths of tens of thousands of Americans every year. But because it's easy to identify those harmed by side effects, and difficult to identify who might have been saved by earlier introduction of Septra to the marketplace, the FDA tends to be over-conservative in its regulatory process.”