House rejects experimental drug bill

House rejects experimental drug bill

Key patient groups and senior Democrats pushed back, however, saying the FDA already has an "expanded-access" program for terminally ill patients that approves almost all requests. The bill defeated on Tuesday would have allowed patients access to medicines that had been determined by the FDA to be safe for people, but not yet approved to be effective.

"Right to Try provides a new path for people who are out of options", said a letter circulated by Goldwater and signed by 20 groups, including the Abigail Alliance for Better Access to Developmental Drugs, Fire Fighters with Parkinson's Disease and Cures Within Reach.

The "right-to-try" bill, which President Trump had called for in his State of the Union speech this year, had strong bipartisan support - but it still fell shy of the two-thirds majority needed to pass under the fast-track rules the GOP set for the bill.

Republicans are hoping for House approval Tuesday, seven months after a similar package cleared the Senate.

The intense, emotional debate surrounding the bills masks a fundamental question: Would a federal right-to-try law have much impact on patients?

Democrats, backed by scores of patients' and research organizations, said the bill would achieve little since the federal Food and Drug Administration already approves 99 percent of the 1,000 requests it receives annually for an existing program that lets patients use unproven treatments.

As noted above, the House version of the law would require any drug used have gone through at least phase I of an FDA clinical trial. Manufacturers would still not be required to provide their pharmaceuticals.


The bill does, however, include a useful transparency measure, she said.

New Jersey Rep. Frank Pallone, top Democrat on the House Energy and Commerce Committee, said the measure is risky, unneeded and "provides false hope to patients".

House Energy and Commerce Committee leaders had been working to change the bill, which passed the Senate by unanimous consent over the summer. In congressional testimony in October, Gottlieb suggested that lawmakers limit the scope of the legislation to avoid undercutting the FDA's drug-review process. The Senate version of the bill applies to patients with "life-threatening" illnesses, which the FDA argued was too broad a category.

Holly Fernandez Lynch, a bioethics expert at the University of Pennsylvania, said the FDA acts as clearinghouse for useful information across companies, so cutting them out of the request process could be harmful. Both chambers' bills would permit the FDA to consider adverse events as part of a drug-approval review, but only if such complications are "critical to determining the safety" of the drug. They said the Food and Drug Administration's current regulatory framework is meant to protect patients, and that the FDA has a program that approves almost all requests of patients to try an experimental drug.

But the bill had its share of critics outside the House cambers, who said it failed to address the problem of gaining access to experimental treatments because it did not require that drug companies allow those treatments to be accessed.

But Christopher Hansen, president of the American Cancer Society Cancer Action Network, counters that the legislation would raise the risk for patients.

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