FDA extends approval of Roche's Tamiflu

Roche ($RHHBY) has spent the past few months getting raked over the coals by critics who say the company has not offered full and complete access to Tamiflu data. So when the FDA extended the approval of the flu drug, the news came as a much-needed boost.

The FDA deemed the drug safe for the treatment of acute, uncomplicated influenza in infants 2 weeks of age and older. Doctors prescribe the medication--co-developed by Gilead Sciences ($GILD)--to lessen the duration and severity of the flu by preventing the virus from replicating in the body. Tamiflu does not stand in for the flu vaccine.

"We are very pleased that this approval provides parents with a medicine for children as young as 2 weeks old, particularly because the CDC advises against vaccinating infants less than 6 months of age," Hal Barron, Roche's chief medical officer and head of global product development, said in a statement.

Pleased, indeed. In October, British Medical Journal Editor Fiona Godlee published a sharp-tongued open letter to Roche board member Sir John Bell asking the company to open access to the pharma's trial data on Tamiflu. About 60% of Tamiflu data sits unpublished, Godlee wrote, and studies have found that published trial data leans positive while negative data remains in the dark.

Roche responded to critics at The Cochrane Collaboration at the end of November, offering to set up an advisory board to review all of the data on Tamiflu. The board, composed of academics and other experts, will decide how best to analyze the data. Cochrane researchers question the drug's effectiveness and for years have prodded Roche to open up the books. Many countries stockpile Tamiflu in case of a pandemic.

Still, the level of access Roche will provide remains unclear. "To what level data will be shared proactively and constantly is something we need to discuss," Daniel O'Day, Roche's pharma chief, told Reuters at the time.

- see the release
- read the BMJ open letter

Special Reports: Fierce's 2012 Top 10 FDA Red Flags | Top 10 selling flu vaccines of 2012