Manufacturers Must Give Six-Month Notice for Stoppages
- By BSTQ Staff
The U.S. Food and Drug Administration (FDA) has issued a final rule that requires manufacturers to give six months’ notice if they plan to discontinue or interrupt production — the same timeline industry has been operating under for the past three years. The rule implements a key provision of the FDA Safety and Innovation Act, which is expected to have an outsized effect on manufacturers of generic injectable drugs. Products listed in the rule don’t have to meet the definition of “medically necessary” as used in the Center for Drug Evaluation and Research’s Manual of Policies and Procedures and the Center for Biologics Evaluation and Research’s Standard Operating Policy and Procedure on shortages of regulated products, which refers to drugs that have no appropriate substitutes.
Under the rule, reportable stoppages include:
- A business decision to permanently discontinue manufacturing a product;
- A delay in acquiring active pharmaceutical ingredients that is likely to lead to a manufacturing disruption;
- Equipment failure or contamination impacting the quality of drugs or biologics;
- Production shutdown for maintenance purposes that extend for longer than anticipated;
- Business mergers or transfer of applications for a covered product to a new firm, if this is likely to cause a disruption in support; and
- An interruption in manufacturing that may not cause a market-wide shortage of the product but will still result in disruption of the drugmaker’s product.
Interruptions don’t have to be reported if production is expected to resume in a relatively short time frame. In the event of a natural disaster, companies have five business days to file notice.
According to FDA, early notice of production shutdown by manufacturers of life-supporting and life-sustaining drugs and biologics has allowed FDA to avert more than 550 potential drug shortages in the last three years. Since the rule was issued in 2011, early notifications jumped from 10 per month to 60 per month. FDA anticipates it will receive 305 notifications of production shortages from 75 firms annually.
