FDA to take a harder look at custom blending of drugs

WASHINGTON -- The Food and Drug Administration has reversed its hands-off stance toward pharmacists who custom-blend drugs using bulk ingredients and is pledging stricter oversight of their work, known as compounding.

The change is a concern for pharmacies that make hormone replacement therapies and other treatments based on doctors' specifications. Compounding pharmacies, like Johnson Drug in Waltham, blend and dispense up to 5 percent of the nation's prescription treatments. Their customized products can feature lower drug doses for children or omit an ingredient to which patients are allergic. Until now, the FDA has quietly condoned the practice.

But this month the regulatory agency 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.

Terry L. Scarborough , the attorney who argued the plaintiffs' case in Texas , predicted the ruling -- due any day -- would have a ripple effect across the nation.

``It will have impact across the board because it will be the first time in this country that a court has ever ruled to that effect and the FDA will have to confront that," said Scarborough, a lawyer with Hance, Scarborough, Wright, Woodward & Weisbart . The FDA is ``simply in denial right now" about compounding, he said.

One of the more popular prescriptions that Bernardi sees is for ``Tri-est ," which combines three estrogens and progesterone , hormones that decline as women age. A technician and a pharmacist make the compounded prescription under a specialized hood in the pharmacy's lab.

Candace Steele , a Wyeth spokeswoman, said the company is primarily concerned about women's health. Some patients are given compounded hormone replacement therapy without warning information that accompanies FDA-approved drugs, Steele said, while others are told the drugs have lower risk for such problems as breast cancer .

``The agency has said all estrogens carry the same risk. We're concerned that women are not being provided the warning information that is associated with these agents," she said. ``If they don't receive that information, it's implied it is safe."

And while Wyeth competes with compounded drugs some proclaim are safer, its hormone replacement therapies have been targeted in lawsuits alleging they increase cancer risk. Last week , the company began defending itself against one of those suits in an Arkansas court.

To Bernardi and other independent pharmacists who compound drugs, the stakes are high. In an era of patient-driven healthcare, additional restrictions on their ability to blend drugs could erode consumer choice, they say.

``There has been extensive medical literature that says that you're better off taking something that is bio-identical to your body, as opposed to something that comes from an animal," Bernardi said.

An influential doctors' group, however, sides with Wyeth when it comes to hormone replacement treatments.

Dr. Isaac Schiff , who chaired the American College of Obstetricians and Gynecologists task force on hormone therapy, said he typically turns down women who want prescriptions for compounded hormone replacement therapy, though he writes prescriptions for other compounded drugs.

``I'm not aware the compounding pharmacy will be able to give them something that I can't," said Schiff, who is chief of obstetrics and gynecology at Massachusetts General Hospital . ``With the commercially available products, I know much more about the risks, the side effects, and the quality of the product."

So far, Bernardi has not heard from the FDA. He's trying to keep it that way by practicing ``ethically and legally and morally," he said.

A compounding pharmacy ``is something that is different and is looked at in a different light by the FDA," he said. ``So it's kind of like you're under the spotlight."

Diedtra Henderson can be reached at dhenderson@globe.com.