News and Publications
Expanding Nonprescription Access is a Priority for New FDA Commissioner Dr. Marty Makary
In confirmation hearings, Dr. Makary proposed that consumers and patients should have easier access to treatments and devices that can help prevent and manage health conditions. In his testimony, Dr. Makary proposed “Moving medications to over-the-counter. Does naloxone really need to be a prescription only medication? Does an EpiPen need to be prescription only? They can be over-the-counter and we can feel confident about public safety with those products on the shelf at the pharmacy. It would force the companies to put a price on the shelf and I do believe in price transparency. I do think there's a lot of areas we can ask does a drug need to be prescription when it can be over-the-counter.”
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Under Dr. Makary’s leadership, FDA can advance this objective with its Final Rule for Additional Conditions for Nonprescription Use (ACNU), which the Agency finalized after more than a decade of research, analysis, and testing. The ACNU Rule provides additional safety – or an extra step – that makes sure consumers can correctly choose and/or use a drug product that is right for them, but that would otherwise require a prescription. Safe nonprescription access to certain drug products has the potential to reverse undertreatment and noncompliance, thereby serving public health.
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Is the ACNU Access Pathway a Tool to Help Manage GLP-1 Cost?
A recent LinkedIn post about the runaway costs of GLP-1 drugs and their impact on Employee Health Plans caught our attention. Last Fall, at the Nicholas Hall NA Conference, we invited a keynote speaker from CATO, Professor Charlie Silver, who had written a white paper on the concept of OTC Ozempic. Obviously, a blue-sky concept at that time. Yet, only a few months later we have such skyrocketing costs of Rx GLP-1 utilization that Dr. Eric Bricker reports Employers may be ready for conversion to a single payer healthcare system to rein in these costs. Quoting Dr. Bricker:
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“Alternatively, GLP-1 medications pose such a great financial burden to Employers that they may agree to a single-payer healthcare system run by the Government as a way of addressing the problem.”
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There is another way to address the problem. FDA has worked for more than a decade to map out an access pathway under a new Final Rule for Nonprescription Drug Products with an Additional Condition for Nonprescription Use (ACNU). The Rule is designed to improve access to treatment and reduce burden to the healthcare system. The GLP-1 drug class may be a candidate for exercising this access pathway.
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Clearly, some of the GLP-1 utilization is discretionary. According to Kaiser Family Foundation, four in ten adults say they took a GLP-1 medication primarily to lose weight. At least some portion of this utilization may be better served through a gated, safe, data-driven nonprescription pathway that complies with the ACNU Rule. The ACNU pathway is also an antidote to online prescribing that relies fully on patient self-reported clinical measures. As envisioned by FDA, ACNU will require patients, or consumers in this case, to take an “additional step” to make sure the individual can correctly choose and/or use the right drug product on their own. There is nothing casual about the Additional Condition; it must include key elements defined by FDA and will be fully reviewed and only approved by the Agency if it can prove its ability to assure its intended effect.
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In keeping with U.S. drug law, the healthcare system burden associated with dispensing of drugs by prescription must be limited to only those drugs for which such burden is truly necessary. FDA has put forth an innovative pathway that the drug industry would be wise to explore before accepting the fate of a single payer system.
This opinion piece from the CATO Institute grabbed our attention when it appeared in the public domain recently. Certainly, in the U.S. we have issues with the high cost of drugs and we realize that our healthcare system is overwhelmed trying to address many self-manageable conditions. The authors make a rational public health argument for nonprescription drug access to address these pressures when it comes to weight loss. The operational scenarios they suggest, however, do not include the elements of FDA’s rule for Nonprescription Access with an Additional Condition for Nonprescription Use, which is expected to be finalized shortly and which we imagine could add viability to the idea of nonprescription access to GLP-1 drug treatment. Thought Leaders are pioneering new frontiers for nonprescription access – public health, consumers, and industry all stand to benefit.
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Nonprescription Drug Product With an Additional Condition for Nonprescription Use
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