Be Bold: Create a High-Cost Drug Database to Assure Affordable Medication Access in the U.S.

A practical, market-driven solution to the drug pricing crisis

The theme of this week's HLTH USA conference is Be Bold . Healthcare in the United States must move beyond sick care to find a better path forward, but with prices so high on the medications most needed to prevent chronic disease, how can transformation come?

I have a simple idea.

We Need a High-Cost Drug Database.

The rising cost of prescription drugs has become a major public health challenge in the United States. So long as Americans pay significantly more for medications compared to other countries, essential drugs remain out of reach for millions.?

According to a RAND Corporation study , drug prices in the U.S. are, on average, 2.5 times higher than those in other high-income countries. GLP-1 medications, in particular, are priced at levels as much as 10 times greater in the United States than the very same meds sold in international markets such as the UK and Australia. These high prices are a significant barrier to access to these life-changing medications.

Why Public Health is at Stake

In the case of weight loss medications, FDA calling an end to the shortage of tirzepatide and semaglutide could cause millions of people to lose access to their medication overnight because they are unable to access the much higher cost of brand-name medications.? This would be a huge setback for public health and our nation’s obesity crisis, which is only just now beginning to improve.

We must not allow the eventual end of the shortage to mean far fewer people have access to life-saving medications.

There are a few things, big and small, that policymakers could do to help with this challenge.

Agency Action

The U.S. Food and Drug Administration (FDA) currently maintains a drug shortage list. According to the FDA , when a drug is in shortage, compounding pharmacies may prepare a compounded version of that drug if they meet certain requirements in the Federal Food, Drug, and Cosmetic (FD&C) Act.

FDA considers data from the manufacturer when determining when to remove the drug from the shortage list. A commonsense, simple change would be for FDA to seek data beyond those from the manufacturer in order to understand the real demand for the drug. Further, FDA should more heavily scrutinize data when analyzing the ability of the manufacturer to meet future demand.?

There is another step that the U.S. Department of Health and Human Services (HHS) could take to more directly address access issues for high-priced drugs. HHS could maintain a public database of medications that are priced 50% or more above the global average.

Such a database, the High-Cost Drug Database, would enable patients and providers to see which drugs are excessively priced in the U.S. It would be another way to hold manufacturers accountable.?

Congressional Action

Congress could also take action to further empower HHS and FDA to increase access to affordable drugs. Lawmakers could consider legislation that would require the FDA to analyze other sources of data and consider meeting future demand when managing the drug shortage list.

Congress could also consider treating the High-Cost Drug Database similar to the current drug shortage list. Meaning, if a drug is listed in this database, FDA-regulated 503B pharmacies would be empowered to manufacture compounded versions of these high-cost drugs. In this way, the High-Cost Drug Database would not only provide transparency for patients and providers, but also introduce competition to drive down costs.?

These additional tools could strike a necessary balance between pharmaceutical innovation and patient access while ensuring life-saving medications remain affordable and available to all Americans.

This graphic illustrates such a concept:

Be Bold.

In one sense, the proposal is modest because we have all the infrastructure in place to implement such a solution. 503B pharmacies are already FDA-regulated facilities authorized to produce compounded medications at large-scale, and they do so successfully, as indicated by the recent bending of the obesity curve in the United States.

503B pharmacies follow current good manufacturing practices (CGMP) just as brand-name and generic medication manufacturers must, and they provide a certificate of analysis (COA) with each batch certifying to sterility, absence of endotoxins, contents, and potency.

Allowing 503B pharmacies to manufacture alternatives to medications on the High-Cost Drug Database would create healthy competition, providing patients and healthcare providers with more affordable options. This strategy would especially benefit essential medications where alternatives are either unavailable or unaffordable under the current system, thereby promoting medication access and improving public health.

It is time for bold action to address the structural flaws in our drug pricing system—and demand that every American has access to the medications they need at a price they can afford.

#HLTHUSA #BEBOLD