At the Association of Accessible Medicines (AAM) February 2024 Annual Meeting Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director of CDER, made an interesting point in her presentation, outlining the number of national drug shortages that the FDA reported per calendar year (reproduced at the link below) and indicating that the press has reported an ever-increasing number of shortages, but the data belie that assertion (see post here).

Tina Reed at Axios reported that drug shortages have reached an all-time high (here). Ed Silverman of Stat also reported that drug shortages reached a record high as 2023 drew to a close (here) saying, “The reasons are varied and many remain a mystery.”

In a recent issue of the AAM e-digest there are two stories on drug shortages indicating that shortages are reaching an all-time high; one from the FDA Commissioner (here) and one from the State of Illinois Senate President Don Harmon (here). The second of these speaks of legislation introduced that makes a bold statement that would make medication available during drug shortages.

The legislation advanced by State Senator Laura Murphy “would require health insurance and managed care plans to cover brand-name prescription drugs if the generic drug is unavailable during a nationwide shortage.” She says, “By making brand-name medication available through insurance when generics aren’t available, we will save patients both time and money. Instead of calling every pharmacy in the area to see if they have medication in stock, patients should be able to get their medication more quickly and with less stress.”

What isn’t mentioned is whether the price charged to the patients would be reflective of the cost share of the generic rather than the brand name drug.

You can’t go a day without seeing news articles about drug shortages. Some blamed the low margins involved in the generic marketplace forcing firms to stop making the product, some blame the DEA quota system for shortages for controlled substances, others blame the problems encountered with the supply chain, compliance problems are also culprits at manufacturers of drug products or active pharmaceutical ingredients, or a myriad of other factors. We know it is a multi-faceted problem and trying to solve it has not been at all a walk in the park.

Mark Cuban, founder of the Mark Cuban Cost Plus Drug Company, [told] Inside Health Policy he could take on the role of distributing the drugs should CMS back drug-pricing advocates’ proposed march-in alternative to license entities to make generic versions of expensive drugs like Xtandi (here; subscription required). While another bold move in the pricing problem for high-cost drugs which also limits public access to certain drugs, however, the shortage issue is likely the most serious issue facing health care providers and patients especially for drug products that do not have an acceptable alternative to the product that is in shortage.

So, what do we do? Sit and wait for a solution? Do we accept higher prices for generics to keep manufacturers in the market? Do we reward manufacturers for good compliance records? It does not seem that we are any closer to universally solving the problem as there are no universally acceptable solutions that can be agreed upon. And as some of the solutions for the problem of drug shortages revolve around low margins for generic products and its impact on accessibility, will one solution for solving the shortage problem by raising cost exacerbate yet another accessibility problem? What’s a mother to do?

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Robert Pollock, M.S., is Senior Advisor, Outside Director to the Board at Lachman Consultants. He joined Lachman Consultants following a distinguished career with the FDA and the Public Health Service. His FDA experience, culminating as the Acting Deputy Director of the Office of Generic Drugs, enables him to provide expert advice and assistance on all aspects of FDA and Regulatory filings. Mr. Pollock is well-versed in the intricacies of International Harmonization Issues, regulatory strategies, standards and filing issues, resolution of FDA regulatory matters, as well as in the resolution of patent/exclusivity issues.