When doctors and nurses are faced with a shortage of medically necessary drugs, they are forced to make challenging decisions about how to ration whatever they have left.
FDA commissioner Dr. Scott Gottlieb is looking to identify ways that the U.S. regulatory agency can help prevent and predict these shortages. In a statement this week, Gottlieb revealed that he’s even considering working with Congress to expand the FDA’s existing authority to require pharmaceutical manufacturers to conduct shortage risk assessments.
Most drug shortages are due to disruptions in the supply chain, the FDA chief noted, not product discontinuation. Beyond manufacturing and quality issues, a shortage of raw materials sourced from one supplier can affect production for multiple drugmakers if they all depend on the same supplier.
Gottlieb said drug shortages can also come about thanks to decisions relating to a company’s bottom line.
“Manufacturers often make production decisions based on business considerations, such as a product’s profitability, manufacturing costs, distribution quotas and patent life. We know that business decisions at any point along the drug supply chain can lead to shortages. Historically, many drugs in short supply have been low-profit generic medications, for which the investment needed to ensure continued production can be less than that for higher profit products,” he explained.
To help mitigate and prevent drug shortages, Gottlieb called on manufacturers to notify the FDA as soon as they experience any disruption that is likely to impact their supply of a given drug. While this is already required under the Food and Drug Administration Safety and Innovation Act of 2012, Gottlieb said that often manufacturers “abruptly discontinue, limit, or delay production under circumstances outside those for which they are specifically required to provide advance notice to the agency.”
“There are other times when companies notify the FDA of potential supply disruptions, but don’t provide enough details to allow us to make the fullest use of our resources to address the shortage. We need to know as much as possible about these shortages,” he added.
Gottlieb also said that the agency will accelerate inspections of production facilities if a new facility is needed to remedy a shortage. The FDA plans to speed up its review process for new or generic drug applications that are designed to serve as an alternative therapy for a product that is in short supply.
To curtail the potential impact of drug shortages, manufacturers need to be better prepared, according to Gottlieb.
“Shortages are an inevitable consequence of an imperfect system. With better planning, we can minimize shortages throughout the supply chain. But, in the near term, we won’t be able to fully eliminate the possibility that new shortages will arise. Meaningfully impacting the structures and market challenges that can give rise to shortages will require more coordination among public and private stakeholders,” he said.
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