FDA "regulates" compounding pharmacies -- for WHOSE benefit?

Compounding pharmacists are important to people like me who have arthritis but cannot take NSAIDs or Cox-2 inhibitors, despite what the pharmaceutical giants like to say. A compounding pharmacist takes prescriptions from physicians and mixes the active medication without incidental materials that are added to the pharmaceutical company's version that may cause allergic reactions or other problems for some patients. Other patients than just people with allergies go to compounding pharmacists as well. But now the FDA is rumbling about whether the compounding pharmacists are creating new drugs that it has authority to approve. Oddly enough, their interest seems to stem from a "citizen's petition" filed by a pharmaceutical giant who seems to feel that the business the compounding pharmacies take eats both at their profits and maybe at their credibility. So, who's money are they using to hound compounding pharmacists? Mine! and yours!

Follow the link in the title for the Boston Globe article reporting that the FDA

issued warning letters to three compounding firms and threatened additional enforcement action. The FDA contends that custom-blended treatments are unapproved new drugs, giving it jurisdiction over pharmacies that sell such products.

Stephen Bernardi , co-owner of Johnson Drug, said he compounds up to 500 prescriptions each month. Nearly half are hormone replacement prescriptions for women who want to ease hot flashes but also want to avoid such products marketed by Wyeth that use ingredients derived from horse urine.

Through a citizens' petition, Wyeth is seeking tighter federal regulation of how pharmacists such as Bernardi inform the public about the safety of custom-blended hormone replacement therapies that compete with the company's drugs. If the FDA agrees, compounded therapies would no longer be marketed as safer alternatives to FDA-approved drugs.

Meanwhile, 10 pharmacists have argued in a Texas federal court that the FDA is wrong to treat products they mix as unapproved new drugs. US District Judge Robert Junell has not issued a written ruling , but he indicated in comments from the bench that he intends to side with the pharmacists.


Stephen Bernardi , co-owner of Johnson Drug, said he compounds up to 500 prescriptions each month. Nearly half are hormone replacement prescriptions for women who want to ease hot flashes but also want to avoid such products marketed by Wyeth that use ingredients derived from horse urine.

Through a citizens' petition, Wyeth is seeking tighter federal regulation of how pharmacists such as Bernardi inform the public about the safety of custom-blended hormone replacement therapies that compete with the company's drugs. If the FDA agrees, compounded therapies would no longer be marketed as safer alternatives to FDA-approved drugs.

Meanwhile, 10 pharmacists have argued in a Texas federal court that the FDA is wrong to treat products they mix as unapproved new drugs. US District Judge Robert Junell has not issued a written ruling , but he indicated in comments from the bench that he intends to side with the pharmacists.

Gee, I wish I thought I could file a citizen's petition and get that kind of action and attention from my federal government agencies! Here is a link to a pharmacy industry new site brief article that explains the Wyeth "petition" as a complaint against compounding pharmacies that mass-produce copies of their products:

Meanwhile, pharmaceutical companies have petitioned FDA to take action against the pharmacies that make copies of their products for patients. Wyeth (Madison, NJ, www.wyeth.com) filed a 36-page citizen petition in October 2005, saying that there is no proof that bioidentical versions of its hormone therapies are safe and effective. The petition has drawn nearly 30,000 comments from physicians, patients, and pharmacists during the standard 180-day comment period.

And here is a link to the FDA's own press release about the matter. Ahem, I wish I felt better-protected. As a DES baby, I think I have some cause to worry.