Noncompliance with Current Good Manufacturing Practices (CGMPs):
The FDA may bring enforcement action against manufacturers found in noncompliance with Current Good Manufacturing Practices (CGMPs). In this case, the FDA would weigh the seriousness of the noncompliance with the medical necessity of the drug before ordering a facility cease production. The FDA offers some assistance and resources for companies wanting to conform to good manufacturing practices.
Some shortages, such as the several year shortage of immune globulin intravenous pentelate, an injectable drug product for boosting the immune system, have occurred after a regulatory agency suspends production because of a manufacturer's failure to meet regulatory standards. Manufacturers that are in compliance and produce the same drug may be unable to meet demand.
A voluntary recall of a drug product can lead to shortages, especially if the drug has no or little competition in the marketplace. When an FDA inspection results in a voluntary recall it can put both the agency and the manufacturer in the difficult situation of having to weigh medical needs against the seriousness of the manufacturing flaw. This is especially true if the flaw has to do with something technical, like labeling, as opposed to contamination or another public health safety issue.
Orphan drugs, those used to treat rare diseases that occur in a small percentage of the population, are produced in short supply by a small number of manufacturers. Shortages can develop quickly if a manufacturer reduces or ceases production because of low profitability.
In recent years the federal government has introduced greater incentives to encourage manufacturers to produce orphan drugs.
Shifts in Demand:
When generic versions of a drug begin to enter the market, some branded, or innovator, product manufacturers may reduce production or withdraw from the market leading to a temporary shortage.
Procurement decisions, such as when a large health care organization or the military begins buying large quantities of a certain drug, can also lead to drug shortages for people outside those organizations.
Sometimes production capacity cannot match sudden, unexpected jumps in demand for a drug. Increased demand can result from a new disease like H1N1 coming on the scene or recommendations for off-label use of a drug.
Natural disasters have, on occasion, damaged or destroyed manufacturing facilities that were the sole producer of a drug, and led to shortages.
For example, a 1997 hurricane in the Caribbean caused damage to a manufacturing plant there that was unable to keep up with the demand for gentamicin, and a drug made from piperacillin and tazobactam.
Where It Stands
Manufacturers can report drug shortages at email@example.com. Biological products including blood, vaccines, tissue and allergenics can be reported to CBERshortages@fda.hhs.gov, or by calling 301-827-4239.
The FDA issues regular reports on drug shortages. You can sign up online to receive FDA email alerts on current shortages.