FDA Foe Gonsalves Gone Soft

So have I because I no longer care. Sorry.

"Former FDA foe now is in its corner" by Matthew Perrone | Associated Press   August 12, 2014

WASHINGTON — As an AIDS activist in the early 1990s, Gregg Gonsalves traveled to Washington to challenge the Food and Drug Administration.

Gonsalves was part of the confrontational group AIDS Coalition to Unleash Power, which staged protests outside the FDA’s headquarters, disrupted its public meetings, and pressured its leaders into speeding up the approval of experimental drugs for patients dying of AIDS.

A quarter century later, Gonsalves still travels to Washington, but with a different agenda: to defend the FDA.

At a recent forum on FDA issues, Gonsalves implored congressional staffers to protect the agency from growing antiregulatory sentiment that he worries will roll back safety and effectiveness standards for all types of drugs. The efforts include new state laws designed to undercut the FDA’s authority by giving patients early access to unapproved drugs and a lobbying push by industry groups to speed up the time it takes the FDA to review new treatments.

Both initiatives come at a time when researchers who study the FDA say the caricature of a slow, outdated bureaucracy is inaccurate.

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The story of how Gonsalves, now a program director at Yale University, went from FDA critic to supporter is intertwined with the AIDS movement’s impact — and its unintended consequences — on the agency.

Groups like ACT UP showed that FDA’s bureaucracy could be influenced by outside pressure. Following protests by ACT UP, the FDA went from taking over two years to approve most drugs to clearing HIV drugs in a few months. In the early 1990s, those shorter review times were written into laws that have governed FDA procedures ever since. But although the push for ever-faster reviews was kicked off by AIDS activists, it is now primarily driven by pharmaceutical lobbying groups and libertarian think tanks....

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It's not that I want AIDS patients to suffer and die; I just don't trust the government that created it to treat it properly. Sorry.

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