Will FDA experts get last-minute Avandia documents?

You know what today is: FDA's expert advisors are meeting to determine the fate of GlaxoSmithKline's diabetes remedy Avandia. The agency delivered 700 pages of documents for the committee's perusal ahead of time. But should they have more material to read?

Lawyers for plaintiffs who allege they've been harmed by Avandia are fighting to get documents in their case unsealed for consideration by the agency. "We think there are very important documents involved," Joseph Zonies, one of the lead plaintiffs lawyers, told Reuters.

Meanwhile, the Senate Finance Committee is weighing in, too, with internal company records about the drug. You'll recall that this committee--chaired by U.S. Sen. Charles Grassley, a frequent pharma critic--issued a report earlier this year castigating Glaxo for its handling of Avandia.

If a New York Times story is any indication, those documents could include emails that suggest SmithKline--which merged to form GlaxoSmithKline in 2000--knew about Avandia's link to heart attacks as early as 1999 and the company actively worked to make sure that information didn't get out. "Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK," one email read (as quoted by the Times).

Glaxo continues to maintain that it handled Avandia data properly and provided all relevant info to regulators as necessary. What's more, those lawsuit documents were cherry-picked from 14 million pages submitted by the company, a Glaxo spokeswoman told the Wall Street Journal, which makes them misleading.

So, we're faced with two questions: Will the federal court lift confidentiality restrictions on those lawsuit documents, and if so, will it lift them in time for the advisory panel? And more importantly, does FDA believe these last-minute documents--those from Grassley's committee and those from the lawsuit--should be considered by the advisory panel?

- see the NYT piece
- read the WSJ story
- get the news from Reuters

ALSO: Avandia had $521 million in sales in the United States last year, compared to market leader Actos with $3.4 billion, according to data from IMS Health. That's down from $1.8 billion five years ago. Report

Suggested Articles

WuXi AppTec has appointed Celgene CAR-T program veteran David Chang to lead its cell and gene therapy CDMO, WuXi Advanced Therapies.

Maryland-based Emergent BioSolutions has won a $628 million contract with BARDA to manufacture targeted COVID-19 vaccine hopefuls.

About 76% remdesivir patients had at least one point of clinical improvement on a 7-point scale at day 11, versus 66% of patients on standard care.