Public Citizen Lobbying For Increased FDA Regulation With Generic Drugs

Public Citizen, a consumer organization consisting of more than 225,000 members and supporters nationwide, has acted as the people’s voice in the capitol since 1971. By actively supporting public interest, the organization has successfully challenged corrupt practices in the pharmaceutical, nuclear and automobile industries. Continuing with their efforts, Public Citizen has recently submitted a petition to the U.S. Food and Drug Administration (FDA). In their petition, Public Citizen requested that generic drug manufacturers provide adequate warnings on their labels that reflect any changes or risks that have come to light since the drug was approved for marketing.

According to the Hatch-Waxman Amendments, otherwise known as the Drug Price Competition and Patent Term Restoration Act, 1984 witnessed the establishment of the modern system of generic drugs. According to the amendment, generic drug makers are required to match their labeling to their brand-name counterpart, even if post-marketing research discovers new problems associated with the drug. Due to this policy, current FDA regulations prohibit generic manufacturers from ever updating their product labeling. Subsequently, brand-name drugs are required to change their labels so that they reflect any new safety information pertaining to the product.

With the generic industry taking over a significant portion of the pharmaceutical market, it would constitute a gross neglect for public safety if generics were not held to the same standards as brand-name drugs. FDA regulations need to be revised to ensure that generic drug manufacturers can update products and warn consumers about potentially new risks associated with their products. In an attempt to strictly regulate generic labeling practices, Public Citizen is petitioning for increased FDA regulation.

Dr. Sidney Wolfe, director of the Public Citizen Health Research Group acknowledged that “drug safety would benefit if generic manufacturers—who already have access to real-world information about adverse events—could use FDA procedures currently in place for brand-name manufacturers to revise labeling to warn of risks.” Allowing generic manufacturers to change their labels in light of new findings would help protect patients. In order to protect the safety of consumers, Public Citizen has requested, in their petition, that post-marketing monitoring be applied to both generic and brand-name drugs.

The importance of post-approval monitoring for drug safety is well-recognized. As Catherine D. DeAngelis & Phil B. Fontanarosa recently explained:

“Even though the evaluation of new drugs and devices is technically rigorous, the current approach of basing drug approval decisions on clinical trials of efficacy that include relatively small numbers of patients virtually guarantees that the full risks and complete safety profile of these drugs will not be identified at the time of approval. Rather, the full safety profile and effectiveness only manifest as each drug is used in the wider population of patients who are less carefully selected than participants in clinical trials”.

Furthermore, the petition requests that FDA regulations require the labeling to be revised in order to include warnings about clinically significant hazards as soon as there is reasonable evidence of a casual association with a drug. Allison Zieve, director of the Public Citizen Litigation Group acknowledged that “the actions that Public Citizen is requesting would bring FDA regulation in line with the realities of the pharmaceutical market and help to ensure that drug labeling provides adequate warnings to patients based on information that comes to light after the drug is approved for marketing”.

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