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The Branded Pharmaceutical Association Comments on Hydrocodone
Date:9/28/2007

BIRMINGHAM, Ala., Sept. 28 /PRNewswire/ -- The Branded Pharmaceutical Association (BPA) represents specialty manufacturers, marketers, and distributors of pharmaceutical products. Some members of the BPA produce, market or distribute Legacy Drugs, which are older, well-established and well recognized drugs, with a history of safety and effectiveness of at least 25 years. All of these products are manufactured in FDA licensed and inspected facilities using current Good Manufacturing Practices as required by FDA regulation. The clinical effectiveness and safety of Legacy Drugs is evidenced by the extensive history these products have in a wide variety of clinical settings in a diverse patient population. Some of these products have had the trust of physicians and other health professionals for 50 years or more.

In 2006, over 130 million prescriptions were written for products containing hydrocodone. Yet of the over 200 brands of hydrocodone containing cough-syrups only 7 have approval status. According to the FDA release:

The FDA has received reports of medication errors associated with formulation changes in unapproved hydrocodone products and reports of confusion over the similarity of the names of unapproved products to approved drug products.

The Branded Pharmaceutical Association fully supports those FDA actions that improve safety, however this appears to be an over reaction to a few already identified incidents, which could easily be corrected by action against those specific companies/products. Removal of all Legacy hydrocodone containing cough-syrups would create a shortage in the market, and dramatically increase the price and create monopolistic positions as we have seen with time released guaifenesin.

Considering hydrocodone was initially approved on March 23, 1943 as an anti-tussive, it would seem more prudent for the FDA to use its limited resources assuring that marketed products are correctly labeled and prescribed instead of taking actions which severely disrupt the marketplace and will surely be windfalls to a handful of companies. BPA believes in our schools of medicine and continues to support the idea that physicians are fully capable of determining appropriate doses and types of medications for their patients.

The FDA has correctly acknowledged that some of the drugs produced in the unapproved category are "medically necessary" and/or are generally considered to be safe and effective. The Branded Pharmaceutical Association is constantly working to ensure that those products are allowed to continue on the market to better meet the needs of physicians and patients alike.


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SOURCE The Branded Pharmaceutical Association
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