Wednesday, October 10, 2012

Guest Blog: DeLauro Complicates FDA Regs, Panders for Votes

 Guest Blog: By Christopher Shaefer
All guest blogs/letters are published as a courtesy, and do not necessarily represent the views of the Insider Editors. These post are opinion pieces, and burden of proof falls on the author.
    Rosa DeLauro: pandering for votes as elections draw near with her predictable knee-jerk call for new laws, in response to the meningitis crisis.
     Compounding of drugs always has been recognized as being most appropriately regulated by the triad of doctor, patient and pharmacist, with pharmacist practice overseen by the state. FDA regulation of drug products is not practical for regulation of compounding practice which, by definition, is the creation of a specialized product for a patient with a specific need.
     The need for a particular product cannot be anticipated far enough in advance to pass through traditional FDA regulation. It also is not economically feasible to fund studies of drug products used for such a small number of patients. Patient autonomy and access to customized medications are additional justifications for limited FDA regulation of compounded products. Some patients’ needs are unique and thus do not provide financial justification for the expenditures necessary for FDA approval. Those unique patient needs CAN be met, however, through compounding or off-label prescribing. But strict regulation would severely hinder patient access and creating “a single entity responsible for verifying appropriate marketing and safe drug production” as called for by DeLauro would be impractical and—as one would expect from any DeLauro proposal—both prohibitively expensive and redundant.
      Thus compounding is a professional practice most appropriately regulated at the state and professional level. Doctors and pharmacists are licensed by state regulatory bodies and must follow state regulations in order to maintain licensure and good standing. These regulatory authorities can discipline at a professional level or at a criminal level based on the type of violation at issue. These professionals are also guided by professional organizations such as the American Medical Association and the American Pharmacists Association.    

     Likewise, pharmacists traditionally have been regulated by the states that license them. State pharmacy boards have the power to discipline by fine, license revocation, or criminal prosecution.
When a pharmacy compounds a product in mass quantities unrelated to the traditional prescriber/patient/pharmacist triad central to compounding, its activity is more akin to that of a drug manufacturer and the traditional justifications for exempting compounding from new drug regulation become less persuasive. Unfortunately such mass production is precisely what happened in the recent meningitis outbreak. The issue was NOT a lack of legislation; the issue was that the state of Massachusetts and the FDA did not enforce EXISTING laws, guidelines and inspections.

     The FDA's existing guidelines for regulating compounding are here: and here:
      Perhaps the next time a crisis hits, before shooting off her mouth, DeLauro should take a break from the Georgetown cocktail party circuit and actually study our existing laws: something our paid-for-with-your-taxes legislator is SUPPOSED to be doing. Better yet, in November voters should replace this multimillionaire, party-going careerist with Wayne Winsley—so we have a Representative who actually will work for a living."

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