• Tom Girardi

What's Wrong (And Right) With The FDA

We Work to Make the FDA More Effective

This country needs a Food and Drug Administration that has the resources and clear direction necessary to assure the medicines we take and the medical devices we use are safe and do what they claim to do.

The attorneys at Girardi | Keese have played an active role in fighting for a better, stronger FDA - an FDA that is not a captive of big pharmaceutical companies. Our California law firm's partners are familiar figures at the FDA and in Congressional hearings.

The FDA has a great mission.

They need the direction and resources to fulfill that mission.

For too long, the FDA has been the rubber stamp of Big Pharma. There are many reasons why:

The FDA is understaffed. They are dependent on data from drug companies, and they don't have the resources to investigate that data. Big Pharma, in effect, runs the FDA drug approval process.Too many political appointees from Big Pharma have undermined the work of career employees with scientific backgrounds.

They have prevented the staff from doing the good work they are capable of doing.Political ideology has too often been allowed to veto scientific facts and research. If a decision would hurt a big business or if it would conflict with a passionately held belief, that decision was often squelched.

FDA warnings and recalls have been delayed and lives have been lost because Big Pharma or a political ideology has stood in the way of good science.

We are lawyers known for our ability to hold big companies accountable. We want the FDA to be able to do that, too. Lawyers usually get involved after the damage has been done, after people have been injured or killed by dangerous drugs. A strong FDA will make a lot of our work unnecessary - and that's fine with us.