Foreign Health

House Passes Bill That Would Give Patients Access To Experimental Drugs

The House spurred on by President Trump, passed a bill on Wednesday that would give patients with terminal illnesses a right to try unproven experimental treatments.

The measure, which was approved by a vote of 267 to 149, appears to have a good chance of becoming law. The Senate approved a similar proposal last year.

Supporters said the bill would give dying patients a chance to obtain potentially helpful prescription drugs without waiting for the completion of clinical trials or going through a process established by the Food and Drug Administration to allow the use of “investigational drugs” outside clinical trials.

The debate took on partisan overtones.

Republicans, joined by the libertarian Goldwater Institute, said the “right to try” would give patients more control over their care and their own lives.

“I’m a physician and scientist with over 40 years’ experience treating patients, some of whom had the dreaded diagnosis of cancer,” said Representative Phil Roe, Republican of Tennessee. “Six months ago, I was operated on for cancer, and I — to this day — am a cancer survivor. If needed, I would like to have the right to try. A little over three years ago my beloved wife, Pam Roe, nurse and friend, died of Stage 4 colon cancer. She would have liked to have the right to try”.

But many Democrats said the bill would weaken the ability of the F.D.A. to protect patients.

“If you eliminate F.D.A. review, as this bill does, you are putting patients at risk,” said Representative Frank Pallone Jr. of New Jersey, the senior Democrat on the Energy and Commerce Committee. “This is an unprecedented attempt to roll back F.D.A.’s oversight of investigational treatments”.

The bill was opposed by dozens of organizations that represent patients, including the lobbying arm of the American Cancer Society.

The National Organization for Rare Disorders, representing people with rare diseases, said the bill could generate false hopes and “undermine patient safety standards” without increasing access to lifesaving drugs.

Several former commissioners of the F.D.A. said the bill was unnecessary because patients with a serious disease or condition could already obtain experimental medicines through a program known as expanded access or compassionate use.

The agency says it approves 99 percent of the requests it receives under this program, but in some cases, it recommends changes to protect patients before allowing the treatment to proceed.

Mr Trump endorsed the right to try in his State of the Union address in January and again on Monday, on a trip to Manchester, N.H., where he described potential beneficiaries of the bill.

“A patient is terminal,” Mr Trump said. “There’s good progress made with a certain drug. We’re going to make it possible for that patient to get that drug. And maybe it’s going to work. It’s hope.”

Thirty-five House Democrats voted for the bill on Wednesday night, along with 232 Republicans.

The Senate approved its version of the legislation in August without much debate. Opponents of the idea, unable to block it in the House, said they hoped the Senate would now scrutinize it more closely.

The bill taken up on Wednesday was the same one considered by the House last week under a special procedure intended to speed the approval of bills that have broad support. Under that procedure, the bill needed a two-thirds majority for passage, but fell short: 259 House members supported it, and 140 opposed it.

Republicans rejected warnings that the bill would give false hope to desperate patients.

Representative Joe L. Barton, Republican of Texas, explaining why he supported the bill, said he had helped his brother obtain an unapproved experimental drug for liver cancer.

“He took the drug and it didn’t work, but he had that last shot,” Mr Barton said. “I don’t know what this debate about false hope is. When you have no hope, perhaps false hope is better than none at all.”

The House and Senate bills would establish a new pathway providing access to unapproved medicines for certain patients who had exhausted other treatment options. To qualify under the House bill, a patient would have to have some kind of terminal illness: a condition that is likely to cause death “within a matter of months” or “irreversible morbidity that is likely to lead to severely premature death.”

Nothing in the bill would require pharmaceutical companies to provide experimental drugs to patients who requested them. Drug manufacturers sometimes turn down requests because they have only a limited supply or they are concerned about legal and medical risks.

To address such concerns, the legislation would shield drugmakers, doctors and hospitals from some of the legal risks of providing unapproved drugs to patients. Doctors and hospitals would generally be protected unless they engaged in gross negligence or willful, reckless or criminal misconduct.

The American Association for Justice, which represents plaintiffs’ lawyers, complained that the bill offered “broad immunity” to drug manufacturers and doctors.

Mr Pallone said he feared that the bill could “open up the possibility of some charlatan, fly-by-night, snake-oil drug company or manufacturer” promoting the use of drugs whose safety had not been established.

Source: New York Times


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