Recent allegations of research collaboration between the FDA's top drug official - Dr. Janet Woodcock - and a pharmaceutical company underscore the potential for conflicts of interests and the high stakes involved in drug marketing. In fact, over the years the FDA has been involved in many conflicts of interests involving dangerous drugs.
In August, 2009 Amphastar Pharmaceuticals, Inc. filed an ethics complaint against Woodcock alleging that she delayed approval of Amphastar's application for approval of a generic blood thinner because of her ties to it's competitor, Momenta Pharmaceuticals, Inc.. Woodstock co-authored medical articles with Momenta while both companies were competing to win FDA approval for their generic blood thinners.
Although ultimately Woodcock was cleared, this episode shows how closely FDA officials may work with those pharmaceutical companies who seek their approval. It is crucial these contacts be disclosed. The drugs that are eventually approved by those officials are the ones that end up in our bodies. Where the motives of officials at the FDA are compromised, it is those individuals who end up taking the potentially dangerous drugs that suffer the consequences.
This is not the first time Woodcock has come under fire. From the late 1990s through the early 2000s several dangerous drugs approved by the CDER on her watch were pulled from the market because they were sickening and killing people. She has also been criticized for her handling of Avandia, a diabetes drug linked to fatal heart attacks and heart failure.