- Food and Drug Administration commissioner Scott Gottlieb has announced a commitment to taking steps to shortening supply disruptions and reducing drug shortages.
- While the FDA currently tries to mitigate existing shortages, its new goal is to work closely with pharmaceutical manufacturers to prevent shortages happening in the first place, beginning with knowing about supply disruption before the shortages happen.
- The administration is putting in approaches ranging from improving clarity and expediting approvals, to creating better access to new technologies.
Drug shortages, particularly those of critical drugs, are a major challenge for healthcare providers. The uncertainty of supply, which may be at short notice, can mean additional costs, as well as drug rationing and delays to scheduled treatments and procedures, which is stressful both for patients and for physicians.
While there are many culprits, the most common is a disruption in the supply chain of a marketed drug. This is most often caused by manufacturing and quality issues, which may mean use of outdated equipment that needs to be repaired or replaced; unexpected issues with product composition; inability on the part of the manufacturer to maintain its facility or product quality; or issues with the availability of raw materials.
A less common, but still important, cause of shortages is product discontinuation, perhaps because of company mergers, or simple lack of profitability. Low-profit generics with small markets can be particularly vulnerable to this, and it can lead, in turn, to dramatic price hikes if there is only one form of the drug remaining on the market.
Even when there are no challenges to the supply of a drug, a surge in demand, for example as the result of a disease outbreak, the approval of an additional indication for an existing drug, or new practice guidelines, can lead to a temporary shortage.
Under the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), manufacturers are required to warn the FDA of disruptions that impact the supply of prescription drugs for serious conditions. However, there are situations not covered by the law and sometimes companies don't come up with enough information to allow the FDA to address the shortage.
The agency is therefore looking at ways to encourage companies to voluntarily share more information about potential supply disruptions, and in a more timely manner, under the existing law. This could include ways to clarify the information required, or steps that could make communications received more actionable. The additional information could then help the FDA to manage shortages.
Another route would be to speed facility inspections for new suppliers of drugs that are in short supply, or expedite review of drug applications that could provide alternatives. This also includes importing drugs from overseas until shortages are resolved. New technology can also play a role, and the FDA's emerging technology team can support companies looking to improve production to prevent drug shortages. Examples include continuous manufacturing, and the FDA is taking steps to reduce the cost and uncertainty of adopting such new technologies.
As Gottlieb concludes, predicting some forces that can lead to shortages is very hard, as seen with Hurricane Maria in Puerto Rico.
"Given the complexities involved in drug manufacturing, especially for sterile injectable drugs, problems can arise at any point in the process," he says in his statement. "When companies are proactive and have backup lines, and facilities and raw material suppliers are prepared for when things go wrong, we can more readily prevent future shortages."