Lack of Robust Regulations for Generic Drugs Warning Labels Leads to Outcry

  • By: Staff Editor
  • Date: May 04, 2012
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Generic drugs include a major percentage of dispensed prescriptions in US drugs market and have rapidly expanded their reach. According to a survey, one-third to one-half of generic drugs no longer have a brand-name competitor.

Why is generic drug labeling in the news?
Generic drug manufacturers prove their product equivalence to the original drug and normally use the same label information of the reference drug. During this process, information on new adverse effects is gained which would otherwise remain unknown during studies, but manufacturers have no authority to independently change the warning labels of drugs.
Conflict between State and Federal Laws
It was observed that federal labeling regulations applicable to generic drugs were in conflict with claims under state laws. State law required manufacturers of drugs to warn of dangers and provide adequate instructions for safe use of a product, but Federal law requires the labelling on a generic drug to match a brand-name drug label.
Current regulations regarding Generics Labelling:
According to Florida-based Leifer Law Firm, “The Food and Drug Administration (FDA) has established labeling and warnings standards to ensure patients are adequately informed of the risks associated with taking a particular drug”. An original drug manufacturer seeking new drug approval from the FDA is responsible for accurately and adequately labeling the new drug. A manufacturer of a generic drug is only responsible for making sure its warning label is the same as the reference drug.
  • Generic drug manufacturers can’t change warning labels and do not have sufficient information to change the FDA approved labeling, but can propose a change to the Agency, which can then bring about a revision of the brand-name label to trigger a corresponding change in the generic label.
  • Generic-drug manufacturers should prove bioequivalence to the active ingredients of the original drug and demonstrate adherence to FDA-approved good manufacturing processes.
  • FDA regulations provide generic-drug makers with a way to comply with their state-law duty to adequately warn purchasers of the drugs about the newly recognized side effects.
  • The generic drug manufacturer should notify the FDA that the label used by the reference drug manufacturers was inadequate and request that the labeling be amended.
  • According to the Federal Agency, the generic-drug manufacturers have a duty to propose stronger warning labels to the FDA, if they know that stronger warnings are needed to safely market a drug. In case, the FDA understands that a label change is required, it would work with the brand-name manufacturer to create a new label.
  • Generic drug manufacturers cannot update warning labels, even if they become aware of a potential risk not mentioned in the labeling whereas brand-name manufacturers can update warnings and precautions on drug labels before obtaining FDA approval.
  • According to FDA regulations, generic manufacturer should include on its official labelling all the information that is on the official label on the reference product.
  • Generic-drug manufacturers may apply for FDA approval and conduct tests of bioequivalence before the relevant patents expire — without being subject to patent-infringement claims.
Media and Legal Community Reaction
According to Leifer Law Firm, “These regulations made it impossible for the manufacturer to change the label on their own (even if stronger safety warnings are found to be required) and therefore, impossible to comply with both federal and state laws; given this impossibility, injured patients could not bring a state lawsuit”.
The New York Times in its editorial stated that “Many such lawsuits against generic pharmaceutical companies have been dismissed owing to these reasons, as they did not have control over the warning labels and therefore could not be sued for failing to alert patients about the risks of taking their drugs”.
Generic drug labelling in the news:
  • In 2011, the US Supreme Court stated that those harmed by drugs with inadequate warning labels on a generic drug cannot seek legal compensation for their injuries as a consequence to the regulations set by FDA. As a result, generic companies cannot be held responsible for failing to alert patients to problems with their drug.
  • In contrast, a regulation which emerged in 2009 decided that patients could sue the manufacturer of a brand-name drug, if its safety label was found to be inadequate especially when, new drug-related risks are discovered after the drug has made it to market .
Therefore, consumers or a patient who is given a generic drug has no legal recourse, if its safety label is found to be inadequate, which is not the case with a branded drug where the patient has every right to legal recourse for any adverse reaction suffered.
Demands of consumers and public agencies against FDA regulations
Consumers, advocacy groups, public agencies are demanding that the F.D.A. should fix the liability problem by amending its regulations to allow generic manufacturers to change the warning labels. According to them, generic drug manufacturers would create uncertainty about safety, if they are not held liable under state laws. Generic drug labels should be updated in the face of evidence of serious side effects encountered or the sale of drugs stopped, if it is known to be inadequately labeled.
  • Drug companies and Public Citizen – an advocacy group – strongly feel that state law claims should be dismissed and regulatory gap need to be filled in line with the realities of the pharmaceutical market.
  • According to Public Citizen, “Generic drug manufacturers should be given the permission to follow the same steps as the brand manufacturers to warn these adverse effects on the labels. These steps help to ensure that drug labelling provides adequate warnings to patients based on information that comes to light after the drug is approved for marketing”.
  • There have been suggestions from public agencies and consumers that FDA regulations be revised so that generic drug companies can update drug labels to warn about the risks that are reported to them.
  • American Medical Association stated that “It should be the responsibility of all drug makers to conduct reasonable and affirmative safety surveillance and to take appropriate action when significant safety concerns arise especially in the case of generic drugs.”
  • According to officials of Public Citizen Research Group quoted in Pharmalot, “Safety of drugs can be improved, if generic manufacturers who have information about adverse events could follow FDA procedures laid for brand-name manufacturers to revise warning labels of drugs”.


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