Navigation Links
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.


'/>"/>
SOURCE The Branded Pharmaceutical Association
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Teen drinking fuelled by Alcohol-branded Wares
2. Get that wedding ring on if you want to be branded a responsible parent!
3. Drug Companies May Be Penalize For Overcharging NHS Tax Payers Money on Branded Drugs
4. South Africa Wins landmark case against pharmaceutical giants
5. Pharmaceutical giant offers AIDS related antifungal drug free to 50 countries
6. Pharmaceutical giant offers AIDS related antifungal drug free to 50 countries
7. Setting up a new pharmaceutical industry in India
8. Medicis Pharmaceutical company enters pediatric market
9. Supply of Radiopharmaceuticals Hampered by Attacks
10. Pharmaceutical companies are targeting patients
11. FDA approves Watson Pharmaceuticals Oxytrol patch
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... ... , ... According to an article published February 1st on Consumer ... is being recalled due to the discovery that it contains dangerous adulterants. According to ... supplement on the market proven to help people safety lose excess weight, such cases ...
(Date:2/11/2016)... ... February 11, 2016 , ... Florida Hospital presents Heart Health Awareness night ... Louis Blues at the Amalie Arena. The puck drops at 6:00pm, but fans will ... MEGA Heart, prior to the game. The MEGA Heart will be located on Ford ...
(Date:2/11/2016)... , ... February 11, 2016 , ... ... reverse diabetes has been gearing up for their simultaneous grand openings in March. ... about right now that you’re probably wondering, is reversing diabetes possible? According to ...
(Date:2/11/2016)... ... February 11, 2016 , ... veEDIS Clinical ... technology, with highly adaptable algorithms, has been updated to help Emergency Department physicians ... symptoms consistent with Zikas and a travel history to affected regions, or potential ...
(Date:2/11/2016)... Orange City, FL (PRWEB) , ... February 11, ... ... has announced the commencement of a master charity program created to assist the ... every 60 days, working closely with nonprofit organizations and community leaders. Their hope ...
Breaking Medicine News(10 mins):
(Date:2/11/2016)... , Feb. 11, 2016  Governor Andrew M. ... will create 1,400 jobs throughout Western New ... partnership with the SUNY Polytechnic Institute, includes a major ... Building in Buffalo , as well ... manufacturing facility in Dunkirk . The ...
(Date:2/11/2016)... WILMINGTON, N.C. , Feb. 11, 2016 /PRNewswire/ ... a leading provider of custom manufacturing and development ... announces expanded sterile fill-finish capabilities and capacity in ... Substantial growth in demand has driven several recent ... in 2001 it had one filling line with ...
(Date:2/11/2016)... Iowa , Feb. 11, 2016  Proliant Biologicals ... Zealand Bovine Serum Albumin (BSA) manufacturing facility.  The facility ... New Zealand , in Feilding. ... was done to functionally duplicate the systems in the ... same vendors used for U.S. installations.  --> ...
Breaking Medicine Technology: