Tags: drug bill | patient hopes | right-to-try drug bill | health policy

Right-to-Try Drug Bill May Add Risks, Raise Patients' Hopes, Experts Say

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By    |   Tuesday, 13 March 2018 10:53 AM

Experts in the Food and Drug Administration, drug industry, and in health policy are saying that a right-to-try drug bill is only "feel good legislation" that could expose patients to unnecessary risks, Politico reported.

The House of Representatives is expected to vote Tuesday on the bill, which would allow terminally ill people, or those who are likely to die prematurely, to have access to experimental medicines that the FDA has not approved. The Senate already has passed its version of the bill and would likely adopt the House's changes, Politico reported.

"I think this is feel good legislation for legislators, rather than meaningful legislation for people in need," said Kenneth Moch, Cognition Therapeutics president and CEO, in the report.

A former FDA commissioner told Politico that the bill would raise hopes needlessly. "What it may do is raise expectations of vulnerable people and their families that there is some miracle cure that is going to be made available," said Robert Califf in Politico.

Most promising new drugs end up being too dangerous or do not work, with FDA estimates showing that only five to seven out of 100 drugs that enter human testing eventually gain approval, Politico reported.

The FDA's compassionate use program already approves experimental drugs for very sick patients, with a 99 percent approval rate for requests that it gets each year, Politico reported.

Critics of the bill say that it casts the FDA as a roadblock to people getting treatment with unapproved medicines. "The right-to-try approach blames an innocent entity for access problems, and by pushing legislation that targets the FDA, those who advocate for right-to-try are not putting forth viable solutions to these problems. The only way forward is to work with companies and to find out what would make them willing to provide their experimental products to patients who wish to try them," said New York University bioethicist Alison Bateman House in Politico's report.

Rep. Frank Pallone, D-N.J., criticized the bill Monday, The Hill reported.

"We should work together to find a sensible path forward that protects patients and upholds FDA's approval process while ensuring patients, with no other recourse, have access to investigational therapies," Pallone said in a statement, the Hill reported.

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Experts in the Food and Drug Administration, drug industry, and in health policy are saying a right-to-try drug bill is only "feel good legislation" that could expose patients to unnecessary risks, Politico reported.
drug bill, patient hopes, right-to-try drug bill, health policy
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2018-53-13
Tuesday, 13 March 2018 10:53 AM
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