Published August 11, 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 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Both initiatives come at a time when researchers who study the FDA say the caricature of a slow, outdated bureaucracy is inaccurate.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.
Mark Harrington, executive director of the Treatment Action Group, which spun off from Act Up in the 1990s, says AIDS activists have long tried to distance themselves from such anti-Washington efforts. By the mid-1990s, Harrington and Gonsalves were actually pushing for longer, larger studies of HIV drugs. That's because the first drugs approved by the FDA were linked to dangerous side effects, including anemia and nerve damage.
Harrington says the Goldwater-backed state laws are political theater that will not help desperate patients. "They're providing false hope and really pushing quack cures and medicines that could be unsafe and ineffective," he says.
Federal law makes clear that patients do not have a right to experimental drugs and the Supreme Court has refused to hear challenges to FDA's authority over the matter. For its part, the FDA already gives dying patients access to unapproved medicines if drugmakers are willing to provide them.
"The agency stands ready to work with companies that are interested in providing access to experimental drugs," said FDA spokesman Stephanie Yao, in a statement.
But there's nothing in the state laws that require companies to grant early access.
While the FDA faces pushback from conservative activists at the state level, it is also faces industry pressure at the federal level.
House lawmakers have held half-dozen hearings this year on "accelerating the pace of cures in America." The push is part of a pharmaceutical industry-backed initiative dubbed "21st Century Cures," designed to streamline the drug approval process.
"There is no doubt that our antiquated, patch-work clinical trial system makes developing new treatments a cumbersome, expensive and protracted process," said the Friends of Cancer Research group in recent congressional testimony. The group receives funding from Pfizer Inc., GlaxoSmithKline and many other drugmakers.
Some FDA watchers say it's too early to worry about a major overhaul of the agency. Congress is gridlocked and no major health legislation expected to pass until after the next presidential election.
But Gonsalves isn't wasting time. In closing his talk on Capitol Hill last month, Gonsalves warned Senate staffers that a political shift to the right in coming elections could "change the game" for drug safety and effectiveness.
"We will have a different FDA than we have had for the last 30 years."