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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.
Groups like ACT UP showed that FDA bureaucracy could be influenced by outside pressure. Following protests by Nike Shoes For Men High Tops Red 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.
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.
Harrington says the Goldwater backed state laws are political theater that will not help desperate patients. "They providing false hope and really pushing quack cures and medicines that could be unsafe and ineffective," he says. For its part, the FDA already gives dying patients access to unapproved medicines if drugmakers are willing to provide them.
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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.
"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.
have held half a 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.
"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.
Some FDA watchers say it too early to worry about a major overhaul of the agency. Congress is gridlocked and no major health legislation is expected to pass until after the next presidential election.
While the FDA faces pushback from conservative activists at the state level, it is also faces industry pressure at the Nike Shoes Sale Mens
But there nothing in the state laws that require companies to grant early access.
"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 no countervailing narrative that we need a strong FDA."
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.
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 headquarters, disrupted its public meetings and pressured its leaders into speeding up the approval of experimental drugs for patients dying of AIDS.
But Gonsalves isn wasting time. In closing his talk on Capitol Hill earlier this summer, Gonsalves warned Senate staffers that a political shift to the right in coming elections could "change the game" for drug safety and effectiveness.
"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.
AIDS Activist Takes Up a New Fight
The story of how Gonsalves went from FDA critic to supporter is intertwined with the AIDS movement impact and its unintended consequences on the agency.
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 because the first drugs approved by the FDA were linked to dangerous side effects, including anemia and nerve damage.
Supporters have dubbed the measures "Dallas Buyers Club" laws, after the Nike Shoes For Men
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