YOU ARE AT FDA!

Test Drive This! Be an FDA Reviewer!

Below part of an assignment I am giving my students. It would be great to hear the thoughts of people here, both about what is and what should be....

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You are an FDA reviewer and need to balance the benefits and risks of a potential new drug.. What are the most important criteria or data that you think you need in order to make an informed, correct decision?

The circumstances listed below are just to help spark (but not limit) your thinking. Circle and comment upon those you think morst important.

--Your sister-in-law works for the company, and her job is uncertain.

--The company has always had an excellent track record, especially for drugs of this kind.

--The two major phase 3 trials (A and B) submitted for NDA approval were: A with 400 subjects enrolled over six months, and B with 400 S's . enrolled for one year. It is anticipated that many thousands, perhaps millions, of people will eventually use the drug for a chronic condition (thus, over many years).

--The studies submitted within the proposal showed a 37% efficacy (mild to moderate improvement in the condition) relative to 29% for the placebo (sugar pill). Adverse events (potential side effects) were about equal. Thus 63% of subjects showed no improvement (and no evident harm) in the timeframe of the submitted studies.

--The drug is primarily to be used for osteoarthritis.

--The drug is primarily to be used for breast cancer.

--Several large studies show that a competing drug (made by another company) in the same class, and for the same condition, is twice as effective as the drug submitted.

--In one of the trials submitted, the data suggested the drug might increase the risk for heart attacks and strokes, but the “signal” is just under being statistically significant within the trials submitted.

--Same situation as above, and you know that other drugs already approved in the same have shown statistically significant increased risk of heart attacks and strokes.

--Same situation as above two, and your supervisor says you have 48 hours to complete your review because of the PDUFA deadline. So far, most of the other reviewers have supported approving the NDA.. Either point relevant? Either point likely to make a difference in the "real world"?