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

• By: Staff Editor
• Date: May 04, 2012

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.

• 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.

• 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 .

• 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”.