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Letter from the Editor |
Loyd V. Allen, Jr., Ph.D., R.Ph. |
Editorial: Brand-Name Drug Companies Pay to Keep Generics Off the Market
Yes, and its legal�for now! In the July 2006 issue of the American Association of Pharmaceutical Scientists (AAPS) Newsmagazine, the Pharmaceutical Science Update section has an article explaining how brand-name drug companies are resuming payments to generic drug manufacturers to stay out of the market. This occurs after a six-year lull in these exclusionary payment activities.
According to Federal Trade Commission Commissioner Jon Leibowitz, this upsurge in the practice of exclusionary payments may be due to recent antitrust decisions that appear to allow such payments from the Federal Appeals Court.
Generic companies may be inclined to enter into these agreements because of a threat that the branded companies may launch their own authorized generics; authorized generics that could take away part of the generic company's own 180-day exclusivity period, according to the Commissioner (sounds like blackmail).
Two recent court decisions apparently allow the brand-name company to make certain settlement payments to the generic company as long as the latter agrees not to delay market entry beyond the full patent term. According to Leibowitz, "We are seeing far more settlements today that potentially raise competition concerns than before these decisions."
These activities are counter to the 1984 efforts of Congress to create incentives for early generic entry, as well as their efforts in 2003 to use the Medicare Amendments' notification provisions to stop anticompetitive settlements.
How much wider will the arms of the big brand-name companies stretch to continue to increase and control drug prices here in the "free market" of the U.S.? It appears to me that limits are being approached that may lead to a big fall!
More at:
1. www.ftc.gov/os/2006/04/fy2005drugsettlementsrpt.pdf
2. www.ftc.gov/speeches/leibowitz/060424PharmaSpeechACI.pdf
Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief |
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This Week on the Compounders' Network List |
This discussion group of over 1,000 pharmacy personnel worldwide continues to be active with discussions over the last couple of weeks including:
- Bell's Ezee-Flow Prostate Tea
- Budesonide dosing in dogs
- Cilastatin ophthalmic drops
- Dog-with-cough treatments needed
- Emend for a Papillon
- Hyperhydrosis treatments for men, women, and children
- KBr for human use
- Mercaptopurine 50-mg/mL suspension
- Need compounders in UK and Florida for patient referrals
- Need help with a really challenging pediatric patient
- Probiotics
- Scar treatments
- Topical bases
- Treatment options help needed for 10-week-old migraine
Join the list today at www.CompoundingToday.com/CNL and read what others have to say and/or contribute, and what questions are posted. It's easy, free, and informative.
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Time is Running Out! Submit Your USP Comments |
Please remember to review the new draft of USP Chapter <797> (sterile compounding) and submit your comments to the United States Pharmacopeial (USP) Convention. The deadline for submitting comments is August 15, 2006. When submitting comments to USP, please send the International Academy of Compounding Pharmacists (IACP) a copy of your comments so your concerns can be included in their filing. USP has several resources available to you - including a copy of the draft chapter, comment submission forms, a guidebook, webinars and more - at www.usp.org/USPNF/pf/generalChapter797.html.
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International Journal of Pharmaceutical Compounding (IJPC)-American College of Apothecaries (ACA) Survey |
If you received a survey this week from IJPC and ACA, please take a few minutes to complete and return it. The survey was designed to assist ACA and other national pharmacy associations to better serve compounding pharmacies and assist all pharmacists in maintaining the right to compound prescription medications for patients of physicians and veterinarians. The results of the survey will be published in International Journal of Pharmaceutical Compounding (IJPC) in 2007. If you would like to learn more about ACA, please visit their website at www.acainfo.org.
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Drug Information Articles and Abstracts |
Psoriasis is a troublesome condition to treat and not all patients respond to the same therapies. We have added 61 article abstracts with links to obtain the article(s) to our drug information database on new and combination therapies used to treat psoriasis. Check it out at www.CompoundingToday.com and click on the literature search tab or go to this link . Here is a sampling of a few titles:
Combining traditional agents and biologics for the treatment of psoriasis.
Cather JC, Menter A. Semin Cutan Med Surg 2005; 24(1): 37-45.
Combination topical therapy for the treatment of psoriasis.
Del Rosso JQ. J Drugs Dermatol 2006; 5(3): 232-234.
Therapeutic options in the treatment of psoriasis and atopic dermatitis.
Gottlieb AB. J Am Acad Dermatol 2005; 53(1 Suppl 1): S3-S16.
Fumaric acid esters for severe psoriasis: A retrospective review of 58 cases.
Harries MJ, Chalmers RJ, Griffiths CE. Br J Dermatol 2005; 153(3): 549-551.
New developments in topical sequential therapy for psoriasis.
Koo JY. Skin Therapy Lett 2005; 10(9): 1-4.
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Press Release |
EPS CHEMO-SAFETY BAGS
Responding to its customers' needs, EPS, Inc. has expanded its line of resealable bags and transport items with our new CHEMO-SAFETY BAGS. The EPS CHEMO-SAFETY BAGS are constructed from extra-heavy 4-mil gauge plastic for safety, leak resistance, and security when transporting cytotoxic medication.
Each bag has a large yellow imprint area displaying a Chemotherapy Bio-Hazard warning, as well as safety instructions. Packaged in either 100s or 500s, the bags are available in both 6" � 9" and 12" � 15" sizes for convenience and batch preparation.
For additional information, please contact: EPS, INC., 70 Industrial Drive, Ivyland, PA 18974; Toll-Free Phone: (800) 523-8966, Toll-Free Fax: (800) 323-8966; E-Mail: info@medidose.com, Website: www.medidose.com
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Upcoming Issues of IJPC |
Beginning with the July/August 2006 issue of IJPC, a series of articles will be published that are dedicated to helping hospital pharmacies meet the standards or guidelines presented by the following organizations: American Society of Health-System Pharmacists; USP; Joint Commission on Accreditation of Healthcare Organizations; United States Occupational Safety and Health Administration, and IACP. Future articles in this series will focus on initial set-up, nonsterile compounding, sterile compounding, hazardous compounding, and unit-dose packaging.
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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Compounding Tip of the Week |
Set Up Your Keyboard to Launch Applications Quickly
You can set up shortcuts to launch your most commonly used applications as follows:
- Right click on the application's shortcut icon on the screen and select Properties.
- Locate the Shortcut Key Text Box, or select the Shortcut Tab.
- Assign a function key or keys, such as CTRL-F12 for your shortcut.
- Select Apply and Close.
- Now, simply click on CTRL-F12, or designated key(s), to start the application.
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