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Wednesday, October 7, 2015

What the FDA’s approval of “pink Viagra” tells us about the problems with drug regulation

by Julia Belluz
The Vox
Originally published on September 18, 2015

Here is an excerpt:

The episode raised hard questions about the changes wrought by the patient movement and other reforms that have followed. There were excellent reasons for the FDA to bring HIV-positive patients into its deliberations in the 1980s — they provided a crucial perspective that the agency's in-house scientists and officials lacked. But these days, some critics argue that those listening sessions have been hijacked by drug companies. As I found in my reporting, the patients who had lobbied the FDA to approve pink Viagra were often sponsored by the drug's manufacturer.

"The role of pharma in patient groups in the contemporary era is entirely fraught," says Yale Law School's Gregg Gonsalves, who was once one of those HIV activists in the 1980s. "[Drug companies] learned from the early days of the AIDS epidemic that the patient community could be useful allies, and they've poured money into patient groups here in the US and around the world."

So is the FDA approving drugs too easily? Has the push for speed and efficiency now undermined the agency's ability to protect public health? To find out, I took a closer look at the approval of "pink Viagra," which offers a vivid illustration of just how much the FDA has transformed over time — and why those changes worry many experts.

The entire article is here.
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