Us V. Baxter Healthcare Corporation Case Study

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United States v. Baxter Healthcare Corporation
The issue is whether reconstituting, repackaging, freezing, and distributing approved antibiotic drugs make them new drugs.
According to the 21 C.F.R. section 310.3 (h) and section 505 (21 U.S.C section 355, an approved drug may become a new drug if a drug is having a new substance, approved drugs have a new combination, combination of ingredients is changed, new indication, and dosages, method or duration of application/administration is changed.
Baxter argued that the drug could not be the new drug because they just prepared the drug as per label instructions precisely as a pharmacist or physician would do. However, as per 21 C.F.R section 310.3 (h) and 505 (21 U.S.C section 355), the court …show more content…
Drug Price Competition and Patent Term Restoration Act of 1984
This act allowed manufacturers to use Abbreviated New Drug Applications to gain approval for generic versions of approved drugs whose patents had expired.
Code of Federal regulations: 21CFR314 subpart C (21 CFR 314.92 to 314.99)

Porter & Dietsch, Inc. v. Federal Trade Commission
The issue is whether the Federal Trade Commission decision was right on the false advertising order relating to non-prescription weight reducing …show more content…
As per 21 CFR 330, if non-prescription drug does not follow any conditions confined in this section and in a valid monograph is likely to regulatory action.
The FTC argued that the advertisement of Porter & Dietsch product was false and misleading because they stated that the X-11 tablets are having a unique ingredient and user of tablets will lose a significant amount of weight without changing the diet.
Also, the FTC claimed that advertisements confined material omission because it stated that person with certain disease should concern with the physician. As per 21 CFR 330, the requirements of advertisement are not met. So, the decision of the court was in favor of the FTC because Porter & Dietsch could not give the scientific basis for their claim. Also, court agreed with the false and misleading advertisement of the product because the X-11 tablet could produce adverse effects with certain disease.
In the given scenario, the decision of the FTC was right because the requirements of advertisement were not according to the 21 CFR 300. Also, the FTC has authority to order Porter & Dietsch, Inc. to issue corrective advertisement and it’s the responsibility of FTC to protect the consumer against false and misleading
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