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 Act Up, 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 anti-regulatory 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Both initiatives come at a time when researchers who study the FDA say the caricature of a slow, outdated bureaucracy is inaccurate. The FDA reviews most drugs in 10 months and high-priority drugs in six months or less.
And a 2012 review in the New England Journal of Medicine showed that FDA regulators approve new drugs faster than their counterparts in Europe and Canada.
“The rhetoric we hear today is that FDA stifles innovation, that FDA keeps drugs out of patients’ hands. And you know, that was our rhetoric in 1989,” says 50-year-old Gonsalves, now a program director at Yale University. “But there’s no countervailing narrative that we need a strong FDA.”
The story of how Gonsalves 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 while 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.
Since May, three states — Colorado, Louisiana and Missouri — have passed laws designed to allow terminally ill patients to receive experimental drugs that have not been cleared by the FDA. Arizona will vote on its own so-called “right to try” initiative in November and lawmakers in Florida, Oklahoma and Utah are set to introduce similar bills.
All of these efforts are driven by lobbyists from the Goldwater Institute, a libertarian think tank.
Supporters have dubbed the measures “Dallas Buyers Club” laws, after the Oscar-winning movie about an AIDS patient who thwarts FDA regulators by smuggling in HIV drugs from overseas. And lawyers for the Goldwater Institute acknowledge that groups like Act Up helped pave the way for their strategy, though they say more deregulation is needed.
“Many, many groups have been trying to get FDA reform for decades and the only real successful movement was the AIDS movement,” says Christina Sandefur, an attorney with the Arizona-based Goldwater Institute.