Keeping up with Regs
How the DTA is monitoring regulatory issues like drug pedigrees.
Gary W. Price, CEO, DTA
The issue of drug pedigrees has caused a great deal of uncertainty in the supply chain between manufacturers, distributors and third-party sellers or handlers. A drug pedigree is documentation tracing the origin of a drug – following the supply route of drugs shipped from manufacturer to distributor or a third party. The purpose of the drug pedigree is to create a reliable paper trail to circumvent counterfeit drugs from reaching the marketplace. In some cases, the paperwork involved in a drug pedigree is onerous. Certain drugs (such as topical anesthetics) are manufactured and sold inexpensively. Drug pedigrees would add unnecessary costs to safe and effective products used daily in dentistry. As a distributor or distributor sales rep, your business could be impacted by needless regulation, or in extreme cases, prevent distributorships from selling drugs that are required for the comfort of patients.
Currently, the FDA has published guidelines specifying when distributors are permitted to be a seller of drugs as an ADR wholesaler (Authorized Distributors of Record). A distributor that is recognized as an ADR wholesale supplier is currently exempt from drug pedigree documentation. While the FDA reconsiders drug pedigree regulations, individual states are debating their own legislation that if enacted, will create a hodgepodge of various rules and paperwork. Without a uniform FDA common sense approach to drug pedigrees – distributors could be forced to comply with drug pedigree programs in all 50 states.
The Dental Trade Alliance (DTA) is an industry resource for regulatory issues in dental. DTA maintains an active Regulatory Affairs Committee led by its Chairman, Grant Ramaley – well versed in regulatory dental topics and supported by DTA staff. In addition, the DTA retains Dr. Neal Dunning, retired FDA executive, as a leading regulatory consultant who works with dental companies on issues ranging from 510k submissions, to FDA audits to reducing burdensome regulations. DTA is working closely with other distribution professionals, including the Health Industry Distribution Association (HIDA) to encourage FDA and Congress to adopt a
nationwide drug pedigree program that makes sense for the industry, recognizes drugs used in dentistry are low risk and eliminates unnecessary paperwork and costs.
Finally, while DTA continues its work on drug pedigrees, the
association will host a program in May 2008 with FDA to discuss drug pedigrees and will release updates and a final position paper on the subject in the coming months.
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