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AMA Testifies at FDA Hearing on Proposal to Expand Types of Drugs Available Over-the-Counter

For immediate release:
March 22, 2012

AMA concerned about patient safety, sees limited ability of new proposal to improve patient outcomes or medication adherence

CHICAGO – An American Medical Association representative testified today at an FDA public hearing held to obtain input on a proposal that would expand the types of drug products available over-the-counter. AMA Council on Science and Public Health Chair-elect Sandra Adamson Fryhofer, M.D., testified on behalf of the AMA and released the following statement:

“The AMA agrees that medication adherence is a very important issue, but a patient’s confidence in their physician and the prescriber’s emphasis on the need to take the medicine as prescribed is one of the most motivating influences in promoting medication adherence. For a program to be successful on this front, it must be delivered by a trusted source, be personalized to the patient’s situation, reinforce medical need and expected outcomes, segment and target at-risk populations and reinforce and reward initiation and maintenance of treatment.

“We also have concerns about patients taking certain drugs without physician involvement, especially for patients with chronic disease. While the increased availability of certain prescription-based antidotes, such as Epi-Pens, appear to have few if any safety concerns, the FDA has not offered evidence that patients with hypertension, hyperlipidemia, asthma, or migraine headaches can self-diagnose and manage these serious chronic medical conditions safely on their own. This sort of self-diagnosis and treatment conflicts with the kind of care coordination and disease management that both the administration and private sector are trying to achieve through the new health care payment and delivery models.

 “The range of chronic medical conditions or diseases currently managed by prescription drug products that might improve patient outcomes if diagnosed and treated under this proposal is probably limited. An expansion of OTC drug types is also not likely to reduce the burden on emergency rooms.

“We urge the FDA to ensure that under the confines of any new OTC program, the application of new technologies and other conditions of safe use be implemented in a way that facilitates communication with the patient’s physician, promotes collaboration and enhances existing relationships among patients, physicians and pharmacists.”



Shannon O'Brien
AMA Media Relations
(312) 464-4443

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