The Oncologic Drugs Advisory Committee's (ODAC) recommendation that FDA turn down Maxim Pharmaceuticals Inc.'s application to market Maxamine histamine immune stimulant demonstrates the risks posed by failing to follow FDA's advice on trial design.
According to FDA documents, the company declined to accept a number of the agency's recommendations and did not heed warnings from senior FDA officials that its clinical trial plan might not provide data to support approval. As a result of these disagreements, the company and FDA ended up producing analyses of the trial results so disparate that it is impossible even to guess whether the product has any efficacy.
Equally important going forward, the agency also has indicated that it has issues with the company's ongoing trials. Thus if MAXM wants to get a drug on the market, it is likely to have to reach some compromise with the agency on how to run further trials.
Reading FDA's summary of its interactions with MAXM is like watching two trains approaching each other on the same track: it is clear that barring an unforeseen divergence of one or the other, there will be a serious collision.
According to Larry Stambaugh, chairman, president and CEO, MAXM pursued an independent course because