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FDA’s Proposed New Paradigm

On May 1, 2012 @ 2:15 pm In All Articles,What's New?


The Federal Register isn’t high on the average person’s reading list. It is the official Daily Journal of the U.S. government where federal agencies post announcements for public response: www.federalregister.gov [1].

On February 28, 2012, FDA posted a “new paradigm” [2] 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 believes that “routine monitoring, blood tests and determining whether or how well a medication is working, or adjusting doses” could be managed by pharmacists or technologies, which would free up prescribing practitioners’ time for “more seriously ill patients” and would “reduce the burdens on the already overburdened healthcare system and reduce costs.”

To achieve this goal, FDA proposes making prescription medications for asthma, anaphylaxis, migraine headaches, diabetes, hypertension and others available without a prescription.

Before you start thinking this means FDA no longer considers these conditions serious or that you’ll have easier access to medications at a lower cost, read closely. FDA’s introducing new hoops and hurdles called “conditions for safe use” otherwise known as “kiosks, technical aids in pharmacies or on the Internet” in which the patient is guided through a series of algorithms for self-diagnosis and drug recommendation right on down to the printed “permission slip” to purchase the drug “with pharmacist intervention.” This way, “a pharmacist, or consumer (notice we are no longer called patients) could then use the results to determine whether a certain drug product is appropriate.”

Pharmacists would assess whether we have any conditions or risk factors (they’d need access to our “private” electronic medical records) that would prohibit use of a drug or assist us in choosing between various products sold at that pharmacy.

If that’s not enough, FDA is also considering whether the same drug could be available as both a prescription and nonprescription product!

Come on! We think pharmacists are great but they are not our doctors!

March 22-23, 2012, FDA hosted a public hearing at which pharmacy and pharmacist organizations dominated the podium. They eagerly supported FDA’s concepts as actionable and economically feasible without need for additional medical training. They showed slide presentations of technologies that would change the way we shop for better health – for ourselves, our children, our elderly parents – without medical care provider guidance. Nirvana not.

Pharmacists want to be reimbursed (higher health insurance premiums/taxes) or otherwise compensated (higher drug prices) for counseling customers. Someone would have to pay for kiosk space and counseling areas.

Should something go wrong, pharmacists said they won’t be held responsible because they are not physicians. Consumers would have to seek legal remedies through the product manufacturer (pharmaceutical or device company).

Mind you, FDA produced no evidence for their proposed “new paradigm” but asked the public to detail “what types of evidence would be needed to demonstrate that certain drugs could be used safely and effectively in the nonprescription setting with conditions of safe use heretofore not described.” What?

The lone voices of reason at the public hearing were Allergy & Asthma Network Mothers of Asthmatics, American College of Allergy Asthma & Immunology, American Medical Association and the Food Allergy & Anaphylaxis Network/Food Allergy Initiative.

It’s not like patients asked for this. It’s not like we need it. The most difficult part of managing asthma and food allergies is during the learning curve where routine visits (which are never routine) and specialized allergy testing matters! There’s a reason we’re not given unlimited refills for medications – we require periodic monitoring just like our teeth and eyes need periodic check-ups.

The longer our symptoms smolder uncontrolled, the more damage to our airways and ultimately, the more medication and medical services are needed. Chah ching. We don’t need vending machine medical care.”

AANMA funded and conducted the Allergy & Asthma Families Care survey [3] in which 500 respondents were given the option to select among various medical care providers, pharmacists, friends and themselves for diagnostics, routine and emergency care. Score big for physicians (94%), allergists (94%) and zero for pharmacists, friends, and self.

First published in Allergy & Asthma Today [4], Summer 2012, Volume 10, Issue 2.

Article printed from Allergy and Asthma Network Mothers of Asthmatics: http://www.aanma.org

URL to article: http://www.aanma.org/2012/05/fdas-proposed-new-paradigm/

URLs in this post:

[1] www.federalregister.gov: http://www.federalregister.gov

[2] FDA posted a “new paradigm”: http://www.aanma.org/advocacy/fda/

[3] Allergy & Asthma Families Care survey: http://www.aanma.org/wordpress/wp-content/uploads/Families-Care-Survey.pdf

[4] Allergy & Asthma Today: http://www.aanma.org/publication/aat-subscription/

[5] Proposed Asthma Inhalers Puts Patients at Risk: http://www.aanma.org/2014/02/proposed-asthma-inhalers-puts-patients-at-risk/

[6] Lawmakers Agree to Take a Look at Challenging FDA Proposal on Allergy, Asthma Drugs: http://www.aanma.org/2012/05/lawmakers-agree-to-take-a-look-at-challenging-fda-proposal-on-allergy-asthma-drugs/

[7] DIY Asthma?: http://www.aanma.org/2013/04/diy-asthma/

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