Bioidentical Hormones - U.S. Senate Special Committee on Aging

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Senator SMITH. Thank you, Doctor.
Steve Galson.
STATEMENT OF STEVE GALSON, DIRECTOR, CENTER FOR
DRUG EVALUATION AND RESEARCH, FOOD AND DRUG
ADMINISTRATION, ROCKVILLE, MD
Dr. GALSON. Thank you. Mr. Chairman and members of the committee,
I am Dr. Steven Galson
Senator SMITH. You need to hit your microphone.
Dr. GALSON. OK. I am Dr. Steven Galson. I am the director of
the Center for Drug Evaluation and Research at FDA, and a Rear
Admiral and Assistant Surgeon General in the United States Public
Health Service.
I am really very pleased to be here to discuss FDA's role regarding
the compounding of so-called bioidentical hormone products.
FDA has increasingly seen these products prepared and marketed
by pharmacists as part of a practice called drug
compounding. FDA regards traditional drug compounding as combining
or altering of ingredients by a pharmacist in response to a
licensed practitioner's prescription, which produces a medication
tailored to an individual patient's needs.
Traditional pharmacy compounding enhances patient treatment
with individually tailored drugs when a health-care provider decides
that an FDA-approved drug is not appropriate for that particular
patient's care.
Traditional compounding may invnlve reformuiating a drug, for
example, by removing a dye or preservative in response to a patient
allergy. Or it may involve making a suspension or a suppository
form for a child or an elderly patient who has difficulty swallowing
a tablet.
Sometimes, however, the risks associated with compounded
drugs outweigh their benefits. Improper compounding has caused
patient harm and death.
Although many pharmacists are well-trained and well-equipped
to compound certain medications safely, not all pharmacists have
the same level of skill and equipment, and some products may not
be appropriate in the first place for pharmacy compounding.
In addition, compounding large volumes of standardized drugs
and copying FDA-approved drugs circumvents important public
health requirements. These practices undermine the drug approval
process, which is the evidence-based system of drug review that
consumers and health professionals rely on for safe and effective
drugs.
My written statement that you have describes FDA's statutory
and regulatory authority over compounded drugs. FDA has regulated
compounded drugs consistent with its Compliance Policy
Guide on pharmacy compounding, or CPG.
This CPG explains that FDA generally exercises enforcement discretion
toward traditional compounding. But when a pharmacy's
activities raise concerns normally associated with the drug's manu-
.facture and result in significant violations of the Food, Drug and
Cosmetic Act, FDA considers enforcement action. The CPG identifies
some of the factors that FDA evaluates in deciding when and
how to act.