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A compounding leader takes issue with FDA's position that compounding is the production of a new drug that needs to be approved.
The proof of the pudding can be found in the FDA's continuing warnings to pharmacies that compounded medications are new drugs under FDA jurisdiction-this, despite the fact that a recent court ruling questioned the agency's authority to regulate these products. The FDA's position harms all pharmacies and the patients they serve.
Millions of patients-including cancer, hospice, and pain management patients; autistic children; women in midlife, and pets-rely on compounded drugs. Every hospital relies on compounded drugs. Compounding makes thousands of medications available to the forgotten patients, as drugmakers increasingly shelve unprofitable drugs because not enough patients demand them.
The FDA qualifies its position by saying it will exercise "enforcement discretion" only against so-called outliers that violate its vague guidelines. This position puts a cloud over thousands of small community pharmacies, dozens of which have been targeted for inspection, often as the result of complaints from drugmakers whose primary goal is to eliminate perceived competition.
The FDA appears to be the only agency to hold this position. Veterans Affairs actively promotes compounding, and Medicare and Medicaid reimburse for these supposedly contraband medications. Can you imagine a patient in a veterans' hospital being told, "Sorry, we have to operate on you while you are awake because the FDA says your anesthetic drip needs to go through the drug approval process?" This may sound absurd, but it's the official position of the FDA.
The real victims here are patients and doctors. Slowly they may see their options for medical treatment disappear because the FDA has created an environment that emboldens for-profit corporations to seek restrictions against compounded drugs. Lately, at least two insurance companies have denied reimbursement for compounded hormones, mostly because of the FDA's position on compounding-this, despite the fact that some doctors believe compounded hormones are medically necessary for their patients. Unfortunately, for many patients, especially those with low income, denial of reimbursement can mean denial of treatment.
More recently, Genentech announced it would no longer supply compounding R.Ph.s with the cancer drug Avastin (bevacizumab), widely prescribed off-label for eye disease. Because ophthalmologists rely on compounding R.Ph.s to repackage bevacizumab, the move would restrict patients' access to this vital drug. Genentech was criticized for trying to boost sales of another of its drugs for eye disease, Lucentis (ranibizumab), which generates 50 times more revenue per dose than bevacizumab.
Genentech claims it's suspending sales to compounding pharmacies for safety reasons, as prompted by the FDA. But Cowen & Co. analyst Eric Schmidt was recently quoted in the San Francisco Chronicle as saying, "I think this is all about money. I don't think it's about safety." Medicare officials have estimated the move would cost taxpayers up to $3 billion. Yet while doctors, pharmacists, and patients are outraged by Genentech's decision, the company shows no sign it will change its position.
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