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The front page of the May 2001 issue of CleanRooms featured a story about how the U.S. Food and Drug Administration (FDA) began cracking down on shoddy pharmaceutical manufacturing, handing down the stiffest fines in history. They say many in the pharmaceutical industry believe federal regulations are antiquated, while the FDA's desire for drug makers to completely upgrade facilities to state-of-the-art manufacturing plants is the equivalent of financial suicide. From the FDA's point of view, the analysts also say the agency believes drug makers spend too much time on research, development and advertising and not enough on the actual manufacturing process. Furthermore, industry analysts indicate the majority of drug makers, when under the pressure of a compliance officer, merely band-aid facility problems so the product path to the market remains clear. We see all of these aspects from our perches, and a few of our own, most notably an indifference to the law as well as a relationship between an industry and a federal agency that is reminiscent of a rocky marriage. While this space in the past has been used to herald calls to actions on such improprieties, this month it will serve as a warning that we're calling both parties to the table. We're not looking for a fight, we're not even looking to point fingers. We're looking for answers, just like everybody else. Let's open a dialogue, and perhaps a new paradigm will result. Mark A. DeSorbo
Associate Editor