Grassley asks FDA for Paxil review

Seemingly tireless FDA critique-man Sen. Charles Grassley now has his eye on GlaxoSmithKline. He's asking the FDA to review GSK's antidepressant Paxil, which just emerged from a years-long probe in the U.K. Namely, Grassley wants the agency to determine whether the company knew about Paxil's links to suicidality when it asked for U.S. approval, and whether GSK concealed knowledge of those risks as time went on. Grassley is also questioning a particular trial in which, he says, GSK may have assigned patients with previous suicide attempts to the placebo group to inflate suicidal behavior in that group so that the Paxil-taking group would look better. "Essentially, it looks like GlaxoSmithKline bamboozled the FDA," he said during a statement on the Senate floor.

You'll recall that the U.K. investigation--into whether GSK withheld unflattering Paxil data from drug watchdogs--yielded no criminal charges. It did lead to a public chiding from officials, who said the only reason they weren't pressing charges was because U.K. law was inadequate. Immediately MPs pledged to change the law to require drugmakers to fork over all the data they have on drugs they're submitting for approval. Grassley wonders whether U.S. law is also inadequate. "I am asking the FDA to take a look at the same information that was examined in the U.K.," he said in his letter. "And I am asking the FDA if we need to change any laws here in the United States."

- check out Grassley's release and letter
- see the WSJ Health Blog item

Suggested Articles

Post-Tesaro buyout, don’t expect GlaxoSmithKline to spring for more commercial-stage oncology products anytime soon.

Already a fast-growing blockbuster, Novo Nordisk's injectable Ozempic won a major heart-helping FDA nod that could bode well for its oral sibling.

Bayer's new Vitrakvi for tumors with NTRK gene fusions is meeting skepticism in England and Germany, where cost watchdogs on Friday rejected it.