Rule Change for Generic Drugs Safety Labeling Postponed

FDA Postpones Rule Change Requiring Generic Drug Makers to Update Safety Labeling

Under current FDA rules, only brand-name drug makers are responsible for updating and changing safety warnings, also known as “labeling”. Generic drug makers must include the same safety warnings as their brand name counterpart but have no independent responsibility or ability to update safety warnings for the generic drugs they make. Proposed FDA rule changes would require generic drug manufacturers to update safety warnings independently of brand-name drug makers, and without waiting for prior FDA approval, in order to enhance consumer safety by getting critical drug safety information to the public more quickly.

The FDA was originally scheduled to finalize this rule change this month but the safety labeling rule change will be delayed until at least the fall of 2015 after intense objections by generic drug makers, their lobbyists and trade groups succeeded in stalling implantation of the proposed rule changes.

Generic drug makers claim the proposed rule change requiring independent, updated safety labeling would be too burdensome on them, could be confusing to the public if safety labeling for generic and brand-name versions of the same drug differed, would be too costly to implement and would require too much additional time by doctors and pharmacists to keep up with and notify consumers of changing safety warnings.

Generic drug makers also object to the rule change because it would provide a legal basis for holding them legally liable for damages when their drugs harm or kill people. A 2011 U. S. Supreme Court decision found that generic drug makers currently have no legal liability for failure to warn of a drug’s safety risk since they have no independent duty to update safety warnings on their drugs, and must provide the exact same safety warnings as brand-name drugs.

When filling a prescription, most people choose generic drugs over brand-name drugs. According to the IMS Institute for Healthcare Informatics, 86% of prescriptions are filled with generic drugs. People typically choose generic because they cost less than their brand-name counterparts, and because they assume generic drugs are identical to brand-name versions. What consumers do not know is that when they choose a generic drug over brand name, they also give up their Constitutional right to legal action against a generic drug maker if the generic drug injures or kills them.

The proposed FDA rule is an attempt to close this legal loophole, to level the playing field between brand name and generic drug makers, and to enhance consumer safety regarding generic prescription drugs.

We believe consumer safety should not be subject to the whim of the drug maker and we sincerely hope this proposed FDA rule is enacted sooner rather than later in order to protect consumers who use generic drugs. As consumer advocate Allison Zieve of Public Citizen explains, “The extra nine months or so of delay allows a safety gap to continue that can only lead to harm. No drug is safe in all situations. A drug is safe when used in accordance with safety labeling that accurately reflects the known risks. The sooner generic drug companies are allowed to make safety updates, the better for public health.”