Post Marketing Surveillance

Firms are meant to continue to monitor all approved drugs for long-term safety and regularly report results to the FDA.

It is important to note that clinical trials cannot always detect risks that are:

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Relatively rare

Have long latency periods

Affect vulnerable populations

Clinical Trials of Generic Drugs

Distinction Between Bioequivalent and Biotherapeutic

Generic versions of branded drugs need not demonstrate their scientific merits by controlled human clinical trials or other testing the brand name pharmaceutical firms conducted.

By definition, generics may be up to 45% less or 25% more efficacious than branded drugs, yet still meet the legal definition of being bioequivalent.

Generics are not required to provide independent proof of their safety or efficacy to be labeled bioequivalent.

Distinction Between Branded Generics and Generics

The pharmaceutical industry also markets authorized branded generics, which are branded drugs that have lost their patent status but are labeled and marketed as generics.

Both empirical and theoretical studies evince that generic entry is inversely related to price: More generics = lower prices.

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