Editorial: FDA, Wyeth, and Global Harmonization

It's interesting that the federal government, corporations, and standards-setting organizations are participating in and promoting global harmonization, uniformity, open exchange of ideas, and products�but only if it suits them. Case in point: A few weeks ago the FDA responded to a Citizen's petition by Wyeth and, apparently as a part of their response, the FDA ruled that estriol cannot be prescribed by physicians and compounded by pharmacists for patients; in other words, it is outlawed in the U.S. This seems to contradict efforts at global harmonization since all the following products of ESTRIOL are manufactured throughout the world, INCLUDING some by WYETH. Check the following list of estriol preparations that are commercially manufactured, including tablets, suppositories, injections, etc., in other countries.

Source: International Drug Directory (Index Nominum 2000), 17th Edition

*AR = Argentina; AT = Austria; AU = Australia; BE = Belgium; CH = Switzerland; CZ = Czech Republic; DE = Germany; DK = Denmark; ES = Spain; FI = Finland; FR = France; HR = Croatia; HU = Hungary; IE = Ireland; IN = India; IT = Italy; LU = Latvia; MX = Mexico; NL = Netherlands; NO = Norway; PL = Poland; PT = Portugal; SE = Sweden; TR = Turkey; UK = United Kingdom; YU = Yugoslavia.

For a number of reasons, it's hard to believe that the decision of the FDA is truly related to safety or effectiveness; we are unable to discuss all of those reasons within this limited space. The reasons should not be related to the standards of quality of the production facilities because, as is evident from the list above, many major pharmaceutical companies that are also in the U.S. produce estriol products in other countries. So, what is the reason?

It may be time for the FDA to become more transparent in their decision-making process and for those responsible for poor decisions be held accountable. Is that too much to ask? It's the way of the real world. If everything is above board, there must be a scientific explanation for their decision. If not, then the decision needs to be reversed as it appears to be inconsistent with the rest of the world. We are looking for the science�not the politics or the money trail! Obviously if the science is there, properly handled, there's not a problem. If not, then there is a big problem.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

Starting this week, we will include a resource directory for different supplies, products, equipment, etc. needed for you to become USP <797> compliant. This week, we are providing sources for "Sterile Alcohol".

Those listings in bold are regular advertisers and supporters of the International Journal of Pharmaceutical Compounding.

Bayer and the FDA informed healthcare professionals of the market withdrawal of the current liquid formulation of Leukine, a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. It was withdrawn because of an upward trend in spontaneous reports of adverse reactions.

Baxter Healthcare and the FDA notified healthcare professionals of a voluntary recall of certain lots of Heparin as a precaution due to an increase in reports of adverse patient reactions associated with these lots. For information, go to: www.fda.govmedwatch/safety/2008/safety08.htm#HeparinInj

AM@ PAT, Inc. notified healthcare professionals and patients of a nationwide recall of all lots of both Heparin and Saline prefilled flushes. They are distributed under two brand names, Sierra Pre-Filled Inc and B. Braun, sold in 3-mL and 5-mL sizes for Heparin and 3-mL, 5-mL, and 10-mL sizes for Normal Saline. For information, go to: www.fda.gov/medwatch/safety/2008/safety08.htm#Heparin

"I'm too smart to be bought by a slice of pizza"; so says medical students when confronted with the pharmaceutical companies' marketing tactics. Adriane Fugh-Berman is trying to educate the next generation of doctors with a healthy dose of skepticism toward pharmaceutical companies' marketing tactics. For more, see: www.therapeuticsdaily.com/news/article.cfm?contentValue=1684237&contentType=sentryarticle&channelID=33

IJPC has published more articles on implementing USP Chapter <797> than any other professional/scientific journal?

Share Your Sources
If you know of, or have used, a supplier of anything that helps you to become USP <797> compliant, please e-mail the information to Jeannie Couch, at jcouch@ijpc.com. Each listing will be added to our website for all to access.