The FDA last year pulled together the best people from among a number of agencies to try to figure out what could be done about perpetual drugs shortages that create dangers for patients and struggles for doctors and hospitals. After a year of study, its conclusion is that the subject needs more study.
The FDA Tuesday dropped its report Drug Shortages: Root Causes and Potential Solutions with the explanation that includes suggestions that might help relieve chronic shortages but acknowledging that there has never really been any “private- or public-sector effort to collect and analyze comprehensive information to characterize shortages, quantify their effects, or closely observe the contracting practices that may be driving them.”
Therefore, the group said, “we recommend taking steps to increase understanding of the impacts of drug shortages and companies’ contracting practices that may contribute to them.”
The report did find, unsurprisingly, that shortages have been increasing, laying some of the blame on what it calls a “broken marketplace.” It said that “prices rarely rose after shortages began” even though production usually remained below pre-shortage levels, a finding that conflicts with anecdotal evidence often offered by healthcare providers.
The drugs most often in shortage were usually low-price and financially unattractive drugs and were more likely to be sterile injectables and often resulted from production interruptions.
While there are many reasons for drug shortages, it had three recommendations to get at the root causes.
First, collect more information on shortages.
Secondly, it suggested something it has been pushing for some years, rating drug producers on quality manufacturing in hopes that drug buyers will turn to those companies with the highest level of production quality and so less likely to have disruptions from FDA sanctions.
Finally, the FDA reports consideration needs to be given to providing financial incentives to ensure that “manufacturers, especially of older generic drugs, earn sustainable returns on their products.”
While the FDA called for more research, some providers have taken matters into their own hands. Hundreds of providers last year banded together to create their own manufacturing operation to produce drugs that are in chronic shortage. Civica Rx has struck deals with a number of contractors to produce drugs, including Hikma for more than a dozen injectables and Xellia Pharmaceuticals to produce antibiotics.
Germany’s Merck KGaA is taking a completely different approach. Earlier this month, it initiated a pilot program with TraceLink to use “machine learning” to more accurately predict future demand for its drugs.