FDA Mandates Six-Month Notice for Potential Manufacturing Stoppages
Early notice of production shutdowns by manufacturers of life-supporting and life-sustaining drugs and biologics have allowed the FDA to avert more than 550 potential drug shortages in the last three years, the agency says in a final rule mandating early notice.
Since an executive order and interim rule were issued in 2011, early notifications jumped from 10 per month to 60 per month following its publication. Relying on those notifications, the FDA reports preventing more than 280 drug shortages in 2012, followed by 170 in 2013 and 101 in 2014.
The FDA anticipates it will receive 305 notifications of production stoppages from 75 firms annually. Not all notifications would necessarily result in shortages.
The final rule 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, which implements a key provision of the FDA Safety and Innovation Act, is expected to have an outsized effect on manufacturers of generic injectable drugs, a sector that has been plagued by manufacturing quality problems in recent years.
Products listed in the rule don’t have to meet the definition of “medically necessary” as used in CDER’s Manual of Policies and Procedures and CBER’s Standard Operating Policy and Procedure on shortages of regulated products, which refers to drugs that have no appropriate substitutes, the agency notes.
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 shutdowns 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 supply; and
- An interruption in manufacturing that may not cause a marketwide shortage of the product, but will result in disruption of the drugmaker’s product.
Firms don’t have to report interruptions due to routine maintenance or unexpected power outages, for example, if production is expected to resume in a relatively short timeframe. Additionally, the FDA allows companies to file notice of a shutdown within five business days of a natural disaster.
The rule requires the FDA to maintain a list of supply shortages that can be viewed on the agency’s website.
The rule can be viewed at www.fdanews.com/07-08-15-finalrule.pdf. — John Bechtel