Techno Medicine Shifts Costs and Risks to Patients
FDA posted a “new paradigm” for public consideration – one in which routine diagnostic and treatment decisions would shift from our physicians to patients and pharmacists and/or other technologies. FDA’s Register Notice states the aim is to reduce routine care visits, healthcare costs and free up physicians to treat more seriously ill patients.
At Allergy & Asthma Day Capitol Hill, May 9, 2013, Allergy & Asthma Network Mothers of Asthmatics held a Congressional Press Briefing to raise awareness of the FDA proposed paradigm and encourage congressional support to remove asthma and anaphylaxis medications from such consideration. On June 11, 2013, AANMA filed a Citizens Petition requesting an exemption for asthma and anaphylaxis medications from the list of over the counter (OTC) medications. Numerous professional medical societies and nonprofit patient organizations signed on to demonstrate their support of AANMA’s position. To review the petition as filed, click here.
- FDA’s proposal in its Feb. 28, 2012 Federal Register: Using Innovative Technologies and Other Conditions of Safe Use to Expand Drug Products Considered Nonprescription.
- Do-It-Yourself Asthma? Interview with Janet Woodcock, MD, Director of FDA’s Center for Drug Evaluation and Research; first published in Allergy & Asthma Today, Fall 2012
- “FDA proposal threatens access to care for asthma and allergy patients,” Nancy Sander Op-Ed published in The Hill newspaper, May 2012
- Our article “FDA’s Proposed New Paradigm,” written in response to the proposal and FDA’s March 2012 Public Hearing. First published in Allergy & Asthma Today Summer 2012.
- AANMA’s Allergy & Asthma Families Care Survey – results overview.
Public Hearing Testimony in response to FDA’s proposal:
- Transcript of AANMA’s testimony during the FDA March 2012 Public Hearing — click on “Transcript Day 1 – March 22, 2012″ and scroll to page 84 to read Nancy Sander’s testimony and view her slideshow presentation.
- The American Lung Association – position on FDA proposal
- The American Thoracic Society position on FDA proposal
- PhRMA – Pharmaceutical Research and Manufacturing Association — position on FDA proposal.
- Teva Pharmaceuticals – position on FDA proposal
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