Plenty of people were watching for the FDA's decision on Avandia, not as a bellwether of GlaxoSmithKline's future performance but as another indicator of the agency's drug-safety approach. Some eighteen months into the Obama administration's FDA, the picture is already growing clearer. But a big decision about a controversial drug has to further sharpen the focus.
Experts such as Cleveland Clinic cardiologist Steve Nissen, whose infamous study launched the Avandia debate in 2007, called the FDA's decision to sharply restrict the drug "a reasonable course of action." Though Consumer Reports quickly slammed the agency for keeping the drug on the market even as European regulators pulled it, plenty of others agree with Nissen. After all, the new restrictions will sharply curtail Avandia use, so much so that GSK expects "minimal" sales of the drug going forward. The FDA didn't choose withdrawal, but it came close.
The FDA's decision was also a savvy political move on Commissioner Margaret Hamburg's part, as the Wall Street Journal notes. It not only will pacify patients who wanted to keep taking the drug, but also soothe FDA staffers--such as CDER chief Janet Woodcock--who fought against withdrawal.
The upshot for FDA-watchers? The agency really is toughening up. "The FDA is changing," Cliff Rosen, who served on the Avandia advisory panel, told NPR. It's a big boat. It takes a lot to move it, but it's slowly shifting." Ditto former FDA commissioner David Kessler, who told the WSJ, "This is the new age of drug development and regulation and it's overdue."