Innovative collaboration could address today’s drug shortages productively

Back in December, I editorialized with the headline, “Fix the Drug Shortage Problem—Now,” to call attention to a problem that is no one company’s or organization’s fault, but which is a collective black eye on the entire healthcare delivery system. Most of the shortages involve generics—and within that, generic injectables that pose added manufacturing complexity relative to solid orals. But the branded pharma companies can’t afford to simply look the other way: for one reason, many branded companies are also involved in generics production; for another, when a short-supply generic is substituted for by a more expensive branded product, some patients figure that this is all a game being played to extract maximum dollars from them. The failed effort (again) to allow “reimportation” of drug products sourced outside the US regulatory scheme, which occurred during the Senate deliberations over the PDUFA reauthorization in May, is a testament to the continual fragile relationship between pharma and its customers.

Everyone (including noisy but powerless journalists like me) has editorialized or published position papers on this issue, with a drumbeat rising until the Obama Administration issued an executive order addressing the problem last October. But it is essential to stress that the problem hasn’t gone away—if anything, it’s worse, even as the FDA Drug Shortage Task Force has marshaled more resources, and prevented more new shortages from occurring. But that Task Force has to deal with two harsh realities: there is no legal way to compel a manufacturer to make a product; and, when distributors are involved, you can’t sell what you don’t have. US legislators have called for mandatory advance warning of shortages; HDMA has stressed better communications among trading partners and smarter allocation/distribution practices among its members. These efforts, while worthy, only partially address the problem. Not all shortages can be forecast, especially when a plant upset occurs; and communications between standing trading partners is great, but what can be said to a patient with a life-threatening condition who happens not to use a healthcare clinic inside these trading networks?

Now, the Generic Pharmaceutical Assn. has taken a substantive step forward to address these issues and the broader topic of shortages generally. The “Accelerated Recovery Initiative” it has proposed has moved forward with a contract to IMS Health to collect—voluntarily—production plans and inventories from manufacturers and distributors of short-supply products, and report the outlook to FDA. The plan still needs Federal Trade Commission clearance (mishandled, it is the very definition of “collusion”), and there are probably many kinks to work out. Participation by manufacturers and distributors is essential. But IMS Health says that by late summer or early fall, it could be delivering reports to FDA that will be a big help in identifying not just existing shortages, but potential future ones. Those reports are not going to make shortages suddenly disappear, but they should put FDA in a much stronger position to address—and prevent—new shortages.

Drug shortages are not a US-only problem; there are spot shortages in Europe, and Canada appears to be dealing with a widespread problem calling for federal action. But the US market, the richest and most pharma-friendly in the world, is supposed to operate at a higher standard. A public-private initiative like this can represent the best in shared responsibilities and collective effort by the entire healthcare ecosystem. The problem arises within the “system” of how healthcare is delivered in the US today; it’s great to see the system take action to fix itself. GPhA is to be applauded for its initiative, and IMS Health for having the technical prowess to analyze the system’s parameters.