In December an interim final rule made it mandatory to report certain supply disruptions to the US Food and Drug Administration (FDA). To help companies comply with reporting requirements the FDA has published draft guidance on drug shortages .
Margaret Hamburg, commissioner of the FDA, told reporters the guidance “clearly describes the how, what, when, and why” of notifying the Agency about disruptions that could lead to drug shortages.
For now mandatory notifications are limited to companies that are the sole manufacturers of drugs that are “life-supporting, life-sustaining, or intended for use in the prevention of a debilitating disease or condition”.
Manufacturers should use commercial data or other methods, as opposed to the Orange Book, to tell if they are the sole manufacturer. A company is classed as the sole manufacturer even if another firm produces the same drug in a different strength, dosage form, or route of administration.
Companies that meet these criteria must tell the FDA at least six months before they stop producing the drug, either temporarily or permanently, if the interruption could lead to disruption of supply.
Situations when a manufacturer must alert the FDA include: delays in acquiring active or inactive ingredients; equipment failure or contamination; and shut-downs that go on for longer than expected.
As well as outlining the process for mandatory notifications the draft guidance stresses the need for companies outside the scope of the interim final rule to also send the FDA information about delays.
Until Congress grants it more powers the FDA will rely on companies to voluntarily tell it of any disruptions that could cause a shortage. By encouraging voluntary notifications the FDA has seen a six fold increase in alerts from companies, Hamburg said, and the guidance reiterated the need.
“Voluntary notifications will improve FDA’s knowledge of potential and existing drug and biological product shortages, allowing us to more effectively work with manufacturers to prevent or mitigate shortages”, the Agency wrote.
Making more mandatory
Hamburg said the FDA supports legislation that forces finished dosage manufacturers to report any disruptions. Other speakers also voiced their support for legislation, such as the piece introduced a year ago, that gives the FDA more power.
Peter Adamson, director of experimental therapeutics in oncology at the Children’s Hospital of Philadelphia, said if physicians can make progress in treating a child’s cancer in four weeks, Congress can pass legislation in four weeks.