The Endocrine Society - Comment

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March 26, 2012

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lange, Rm. 1061
Rockville, MD 20852

Re: Using Innovative Technologies and Other Conditions of Safe Use to Expand Which Drug Products Can Be Considered Nonprescription; Public Hearing (Docket No. FDA-2012-N-0171, document number 2012-4597)

The Endocrine Society (Society), representing more than 15,000 physicians and scientists in the field of endocrinology, would like to provide comments for the U.S. Food and Drug Administration’s (FDA) consideration of whether medications for certain diseases or conditions that are currently available only by prescription could be made available without a prescription with certain conditions of safe use. The Society appreciates that the FDA is evaluating which drugs might be appropriate to designate as nonprescription in an effort to improve access and health outcomes, but strongly believes that diabetes medications should not be considered under these new paradigms.

The Society understands that there remain substantial gaps between optimal medication therapy for important medical conditions and the actual state of medication use in the United States. Since workforce shortages continue to be problematic in the field of endocrinology, the Society appreciates the role that allied health professionals like diabetes educators and pharmacists can play in reducing wait times and assisting patients with important tasks like diabetes self-management training and even diabetes medication management programs.

However, diabetes is an extraordinarily complex disease that is often complicated by a number of co-morbid conditions, such as hypertension and hyperlipidemia. Many patients suffer from microvascular complications of diabetes such as retinopathy, nephropathy and retinopathy. Diabetic patients may also develop cardiovascular disease, chronic kidney disease and kidney failure. These patients may often require angioplasty,



The Endocrine Society Comments to FDA on Nonprescription Drug Expansion

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Authors: CDER

Comment Period Closed
May 7 2012, at 11:59 PM ET
ID: FDA-2012-N-0171-0012
Tracking Number: 80fe1692

Document Information

Date Posted: Mar 27, 2012
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Submitter Information

Country: United States
Category: Health Care Association - D0022