Gonsalves

A quarter century after helping to stage protests pressuring the FDA into speeding up the approval of experimental drugs for patients dying of AIDS, Yale University program director Greg Gonsalves now travels to Washington to defend the FDA from growing anti-regulatory sentiment that he worries will roll back safety and effectiveness standards for all types of drugs.

In the early 1990s, protests by ACT UP pressured the FDA from taking over two years to approve most drugs to clearing HIV drugs in a few months. Today, Greg Gonsalves sees new state laws that are designed to undercut the FDA’s authority by giving patients early access to unapproved drugs and a lobbying push by the pharmaceutical industry to speed up the time it takes the FDA to review new treatments.

By the mid-1990s, seeing that the first AIDS drugs approved by the FDA were linked to dangerous side effects including anemia and nerve damage, Gonsalves and others were pushing for longer, larger studies of HIV drugs.

Supreme Court Defends FDA Authority

Although the FDA gives dying patients access to unapproved medicines if drugmakers are willing to provide them, federal law makes it clear that patients do not have the right to experimental drugs, and the Supreme Court has refused to hear challenges to FDA’s authority on the matter.

Under Lobbying Pressure States Pass Laws That Bypass FDA Clearance

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 “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.

FDA Facing Industry Pressure at Federal Level

In addition to facing pushback from conservative activists at the state level, the FDA is also facing industry pressure at the federal level. House lawmakers have held half a dozen hearings this year on “accelerating the pace of cures in America.” Although the FDA now reviews most drugs in 10 months and high-priority drugs in six months or less, the push is part of a pharmaceutical industry-backed initiative called “21st Century Cures” that is designed to streamline the drug approval process.

In his talk on Capitol Hill 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.