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10/20/2015

Gov. Brown’s veto of right-to-try bill

by Lisa Kearns, MS, MA

The conservative press’s reaction to Gov. Jerry Brown’s veto of California’s “right-to-try” bill recently was surprising—not because of the vitriol expressed, or because the writers strongly supported the legislation, which was overwhelmingly popular in the state. What was surprising was that in their rush to criticize the Democratic governor, the veto’s opponents failed to see the harm right-to-try legislation poses for patients—providing mythical hope of a 1-in-5,000 shot at a drug that offers a very slim chance of working anyway.

Some background: On Oct. 11, Gov. Brown vetoed Assembly Bill 159, becoming the first state executive to reject right-to-try legislation since the first law was enacted, in Colorado in May 2014. The legislative right-to-try movement was conceived by the libertarian Goldwater Institute as a way of giving terminally ill patients compassionate, or pre-approval, access to promising therapies that have passed only Phase 1 testing and thus haven’t received FDA approval. Twenty-four states have enacted a right-to-try law to date, and every bill (plus California’s) was passed unanimously or nearly so. Yet Brown didn’t follow suit, writing in his veto that the FDA’s compassionate use program already allows patients to request pre-approval access and that the agency’s efforts to streamline the application process should be given time to work.

The right-wing media was up in arms. “Brown to State: Drop Dead,” read a Wall Street Journal headline (a play on a headline that the Daily News ran after President Gerald Ford refused bailout funds for New York City). The Washington Examiner summed up Brown’s stance as “Suicide good, extending life bad” (the “good” referring to a physician-assisted-suicide bill that Brown had signed six days earlier). Nick Gillespie, at Reason, sarcastically called Brown a “Humanitarian,” whose “sleep should be haunted” by the pleas of a right-to-try advocate with ALS who died earlier this year.

Their chief complaint is that the existing FDA compassionate access approval process doesn’t work fast enough for dying patients (the agency is “plodding” and “life-destroying,” wrote Gillespie). Even though the agency is currently streamlining the process—reducing paperwork time from 100 hours to 45 minutes and greatly reducing the number of supporting documents required—these critics say those efforts are meaningless to those who may not live to see the changes come about. (A cynic could point out that conservative critics might not actually wish for the government—the FDA—to succeed here and so might have other reasons for the strong reaction to the veto.)

What these writers don’t seem to realize is that even if Brown had signed the bill, dying patients still wouldn’t get access to experimental medicines. Section 111548.2 (a) of the vetoed bill states: “This article does not require that a manufacturer make available an investigational drug, biological product, or device to an eligible patient.” In fact, all of the 24 laws on the books stipulate merely that manufacturers may make available products that have completed Phase 1 testing, and all but three include the stronger “does not require” caveat that California’s does.

The formal concept of “right” entails a duty or obligation on the part of another party. By viewing AB 159 through an ideological prism, the journalists above have failed to see that the bill they support plays fast and loose with this definition and have thus overlooked the harm the legislation could lead to: unconscionably holding out the promise of one final chance at life while requiring nobody to fulfill that promise.

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