| Editorial: Exhibit Halls at Meetings Reflect Changes
The first of this week I attended the 20th Anniversary of the American Association of Pharmaceutical Scientists (AAPS) annual meeting in San Antonio. As a charter member of the association, I have only missed about two or three meetings since the association's inception. In addition to the various programs and papers, the exhibits are very educational.
One can learn a lot by visiting the exhibit halls and the various exhibitors. One dramatic change I have noticed at the AAPS meetings is that in recent years there are many more contract research organizations (CROs) than pharmaceutical companies that exhibit. These "support companies" actually do much of the research today under contract with the sponsor (the drug company). In fact, over half of the exhibitors could be classified as a CRO and many of the others are companies that provide support for new drug development, laboratories, etc.
What does this tell you about the pharmaceutical industry? For one thing, many of the drug companies no longer do their own work (research, development, production, etc.). Instead of maintaining expensive laboratories, etc., they find it more economical to outsource much of the product development work. This "downsizing" of in-house research capability has resulted in pharmaceutical scientists being laid off, such as occurred with Pfizer in the last couple of weeks. These laid-off employees are looking for positions with other companies, as they were doing at the AAPS meeting.
An advantage to this scenario is that these CROs specialize in doing certain types of research. The disadvantage is much of the control by the drug company is adversely impacted as it is handed off to these independent companies. This seems to be the trend, and there are many questions that arise concerning confidentiality, focus, timing, etc., but it is a sign of the times.
If many companies in the pharmaceutical industry outsource their research, marketing, legal and regulatory activities, production, etc., then a good question is, what is left at the "plant?" Another trend is for contract manufacturers to also produce or manufacture the final product. You have to question if a product really is "of the drug company" or is it produced by the "lowest bidder?" I think I remember something from E.R. Squibb entitled "The Priceless Ingredient" about the value of their product and their reputation. It seems that this may no longer hold in the pharmaceutical industry, as the "products" may now be comprised of the efforts of numerous diverse companies. How things have changed!
Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief |
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FDA's Motion to Alter the Midland Decision is Denied
Following Judge Junell's August 30 ruling that compounded medications are not new drugs subject to US Food and Drug Administration (FDA) oversight, the FDA filed a motion with the court to alter or amend the decision. The action by the FDA was not surprising and was likely a routine matter of exhausting all options before appealing the decision. On October 2, the court denied the FDA's motion. The FDA has 60 days to appeal to the Fifth Circuit Court of Appeals. The FDA has not yet given indication of its intentions regarding an appeal. If there is an appeal, it would afford an opportunity for outstanding issues to be clarified. The government would write the first brief in the appeal to the fifth circuit. At such time, we would see how the government approached the 503A and other outstanding issues and begin to work with the plaintiffs to respond appropriately.
FDA Drops its Case Against BET Pharm
On September 25, in a federal district court in Kentucky, the FDA reached a settlement agreement with veterinary pharmacy BET Pharm and dropped its case that compounding for nonfood animals from pure pharmaceutical ingredients is illegal.
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Need more information on how to treat hyperpigmentation, inflammatory skin disorders, and aging skin with an emphasis on using chemical peels? Take a look at the 52 abstracts on this topic. Also, 11 other abstracts on miscellaneous dermatological topics have been added to CompoundingToday.com's literature search database this week. Here is a sampling of them:
Safety of ingredients used in cosmetics.
Bergfeld WF, Belsito DV, Marks JG Jr et al. J Am Acad Dermatol 2005; 52(1): 125-132.
Topical agents used in the management of hyperpigmentation.
Halder RM, Richards GM. Skin Therapy Lett 2004; 9(6): 1-3.
Acne: Treatment of scars.
Jemec GB, Jemec B. Clin Dermatol 2004; 22(5): 434-438.
Chemical peels.
Monheit GD. Skin Therapy Lett 2004; 9(2): 6-11.
Review of skin-lightening agents.
Rendon MI, Gaviria JI. Dermatol Surg 2005; 331(7 Pt 2): 886-889.
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