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What is the USV PHARMACEUTICAL CORPORATION v.
Caspar W.
WEINBERGER case about?
The case centered around a dispute over the regulatory status of certain citrus bioflavonoid drugs marketed by USV Pharmaceutical Corporation.
Prior to the 1962 amendments to the Federal Food, Drug, and Cosmetic Act, these types of bioflavonoid drugs were not considered "new drugs" and could be marketed without undergoing the new drug approval process.
After the 1962 amendments, the FDA took the position that these bioflavonoid drugs were now considered "new drugs" and required approved new drug applications (NDAs) to be legally marketed.
USV argued that its bioflavonoid drugs should be grandfathered in and exempt from the new drug approval requirements based on their prior marketing history.
The case hinged on the specific language and interpretation of the grandfather clause in the 1962 amendments, known as Section 107(c)(4).
The Court's decision upheld the FDA's authority to require NDA approval for these types of previously marketed drugs, even if they had not been considered "new drugs" prior to the 1962 amendments.
The case highlighted the tensions between drug manufacturers' interests and the FDA's regulatory authority over drug approvals in the changing landscape of pharmaceutical regulation.
The ruling set an important precedent regarding the scope and application of the grandfather clause provisions in the Federal Food, Drug, and Cosmetic Act.
The case was significant in establishing the FDA's ability to reclassify previously marketed drugs as "new drugs" subject to the NDA approval process.
The decision reinforced the FDA's role in ensuring the safety and efficacy of drugs before they can be legally marketed in the United States.
The case was part of a broader effort by the FDA in the 1970s to bring a wide range of previously marketed drugs under the new drug approval framework.
The ruling had implications for the regulatory status of many other types of drugs beyond just the citrus bioflavonoid products at the center of the USV case.
The decision highlighted the challenges faced by drug manufacturers in navigating changing regulatory requirements and the need to maintain up-to-date compliance with evolving drug approval laws.
The case illustrates the important role of the courts in interpreting and clarifying the boundaries of regulatory authority granted to agencies like the FDA under federal statutes.
The ruling underscored the FDA's responsibility to protect public health by ensuring that all drugs meet appropriate safety and efficacy standards before being allowed on the market.
The case was a significant victory for the FDA in its efforts to tighten regulation of the pharmaceutical industry in the years following the 1962 amendments.
The decision reinforced the FDA's position as the primary gatekeeper for new drug approvals, with manufacturers bearing the burden of proving their products meet regulatory requirements.
The case has continued to be cited and referenced in discussions of the scope of the FDA's regulatory authority over drug products and the application of grandfather clause provisions.
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