| Editorial: FDA is Generating Income and Patients Lose Again
With the millions of dollars the FDA is currently generating as part of the Prescription Drug Users Fee Act (PDUFA) and renewed legislation over the years, it appears the FDA has found a source of new income—Pre-1938 drugs!
The FDA may now require the Pre-1938 drugs to be part of the New Drug Application (NDA) process. In other words, drugs that were exempt from the NDA process (proof of safety and efficacy) because they had already been on the market for many, many years and were generally recognized as safe and efficacious, now may be required to be the subject of costly clinical trials, etc.
In the November 11, 2005 (Vol. 2, No. 43, Unapproved Drugs, What�s the Big Deal?) issue of this newsletter, we listed many of the pre-1938 unapproved drugs that are in common use in the U.S. That editorial discussed the fact that there are tens of thousands of unapproved drug prescriptions (Pre-1938 drugs, compounded drugs, etc.) that are safely and effectively used every day, prescribed by physicians, dispensed by pharmacists, and used by patients. But, some of these drugs may disappear from the market in the future if no drug company comes forth to spend the money needed to conduct the clinical trials to market an FDA-approved product.
Considering what happened to quinine sulfate and the $5 per dosage unit ($500 per bottle of 100) for the new FDA-approved version and the others removed from the market, it is apparent that patients are going to be on the losing end again. Also, it appears that the FDA may monetarily profit from this activity because of the PDUFA fees it may garner from the applications that could come forth.
In summary, while the intent may be good, the patients may suffer. But, it appears that neither the government nor the pharmaceutical industry is attuned to the patient any longer. Thankfully, however, physicians and pharmacists generally are.
Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief
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CompoundingToday.com's literature search database this week looks at skin disorders in 35 citations on bullous disorders, vitiligo, and dermatomyositis along with 34 citations on lots of miscellaneous derm topics some of which have been mentioned on the Compounders' Network List (CNL). Here is a sampling of them:
Autoimmune bullous dermatoses: A review
Bickle K, Roark TR, Hsu S. Am Fam Physician 2002; 65(9): 1861-1870.
Dermatomyositis
Callen JP, Wortmann RL. Clin Dermatol 2006; 24(5): 363-373.
New insights and new therapies in vitiligo
Grimes PE. JAMA 2005; 293(6): 730-735.
Erythema multiforme
Lamoreux MR, Sternbach MR, Hsu WT. Am Fam Physician 2006; 74(11): 1883-1888.
Treatment of refractory polymyositis and dermatomyositis
Ytterberg SR. Curr Rheumatol Rep 2006; 8(3): 167-173.
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Aaron Morrow, Staff Pharmacist at Heart Hospital of New Mexico, Albuquerque, New Mexico, was the winner of a drawing for a Mortar and Pestle at the American Society of Health-System Pharmacists in Anaheim, California. Thanks to the over 600 pharmacy personnel who stopped by our booth to learn about all that IJPC has to offer in print and electronic formats along with CompoundingToday.com.
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The development and compounding of pharmacotherapeutic formulations that are suitable for infants and young children can be a challenging problem. In an effort to improve pediatric therapeutics, the National Institute of Child Health and Human Development sponsored the Pediatric Formulation Initiative as part of its mandate under the Best Pharmaceuticals for Children Act. The goal of the initiative was to address the issues and concerns associated with pediatric therapeutics by convening groups of researchers and experts in pediatric formulations from academia, pharmaceutical companies, the National Institutes of Health, and the U.S. Food and Drug Administration. Part 1 of the summary of the findings of this initiative can be reviewed in the International Journal of Pharmaceutical Compounding's pediatric issue in our January/February 2007 issue, pages 5 through 8, in an article titled Need for Appropriate Formulations for Children: The National Institute of Child Health and Human Development-Pediatric Formulations Initiative, Part 1. If you are not a subscriber you can purchase and download this article at www.ijpc.com/backissues/ArticleDescription.cfm?ABS=2507
Sign up today at www.IJPC.com and start your journal print and electronic subscriptions. You can download what you are currently subscribed to and purchase electronic access to our complete set of back issues.
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Market to your pain management physicians!
The New Orleans convention area has recovered and is a nice place for a convention again. Last week I had the opportunity of speaking in a plenary session on pharmacy compounding (a second speaker spoke on FDA regulations) to the physicians at the American Academy of Pain Medicine. When asked by the FDA speaker how many prescribe compounded medications; most, if not all, raised their hands. The session was very informative and the physicians seemed to strongly endorse compounding for their individual patients. As the tip of the week, market your pain management physicians—they are very supportive of pharmacy compounding!
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