Federal regulators have just issued a proposed rule change that would enable
the makers of generic drugs to update drug labels when they receive safety
information related to their medications. Under current regulations, this
is restricted for generic drug makers, who must ensure their labels contain
the same information as the related brand version.
Approval of the U.S. Food and Drug Administration (FDA) proposed rule would
allow for product liability lawsuits to proceed against the makers of
generic medications, according to
The New York Times. For example, in one recent case, a woman allegedly suffered from serious
neurological effects following treatment with generic acid reflux medication,
metoclopramide. She stopped taking the drug in 2009, after five years,
when the FDA issued a warning about long-term use of the medication associated
with the neurological disorder, tardive dyskinesia, according to NBC Today News.
The woman attempted to sue the generic drug maker, describing the warning
label as "misleading" and "inadequate," NBC Today
News reported. The court dismissed the case, citing a 2011 Supreme Court
ruling in which it was found that generic drug makers cannot be sued.
Under prevailing FDA rules, only the brand name drug manufacturers are
responsible for drug safety warnings, generic drug makers simply need
to copy the brand label and have no control over verbiage. Because of
this, they can also not be held liable, NBC Today News reported.
In other words, under current law, patients do not have the same rights
against generic drug makers as they do against brand name drug makers.
Under the new FDA proposal, that would change. The rule would enable generic
drug makers to update their labels based on new information in the same
way that brand manufacturers are able to. The proposal would result in
potential liability for generic drug makers, and require them to update
drug labels on a timelier basis, according to NBC Today News.
More than two years ago, watchdog group, Public Citizen, petitioned the
agency to close what it described as a dangerous safety gap. "Ultimately,
we believe that the generic companies need to be the ones who are primarily
responsible for ensuring the safety of their products," Dr. Michael
Carome of Public Citizen told NBC Today News. "Right now, no one's
doing it adequately." More than 80 percent of the prescriptions filled
in the United States are filled generically.
The FDA explained that, today, "generic manufacturers must wait to
update product safety information until the corresponding brand name product
has received approval to update its safety information. Brand drug manufacturers
are allowed to independently update and promptly distribute updated safety
information by submitting a 'changes being effected' (CBE-0) supplement
to FDA." In the case of generic drug makers, they are required to
"notify the FDA of new safety information, and wait for the FDA and
the brand manufacturer to determine the updated labeling, which may result
in a delay in getting new information to health care professionals and
Janet Woodcock, M.D., director of the FDA'S Center for Drug Evaluation
and Research, stated that, "This proposal will help ensure that health-care
professionals and consumers have access to the latest safety information
for medications they use."
The Generic Pharmaceutical Association asserts generics are as safe as
the brands, telling NBC Today News that "patient safety is the foremost
concern" and that a change in rules would create "unnecessary
confusion" and "could drive up costs."
The FDA proposal will go through a public comment period before being finalized.
In the meantime, the agency stated that it would be creating a web page
on which safety-related drug maker changes would be available.
- NBC Today News; FDA Moves to Make Generic Drug Makers More Accountable;
by Jeff Rossen and Avni Patel; November 8, 2013; http://www.today.com/news/safety-advocates-loophole-puts-users-generic-drugs-risk-8C11545187
The New York Times; Label Updates May Be Allowed for Generics; by Katie Thomas; November
8, 2013; http://www.nytimes.com/2013/11/09/business/fda-proposes-letting-generic-drug-companies-alter-labels.html?_r=0
- The U.S. Food and Drug Administration; FDA takes action to speed safety
information updates on generic drugs; November 8, 2013; http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm374171.htm
The Federal Register; Proposed Rule: Supplemental Applications Proposing Labeling Changes for
Approved Drugs and Biological Products; November 13, 2013; https://www.federalregister.gov/articles/2013/11/13/2013-26799/supplemental-applications-proposing-labeling-changes-for-approved-drugs-and-biological-products