Approval Process for Generic Drugs - Essay Example

For a generic drug, if bioequivalence with a non-generic drug is proven the two drugs certainly have the same, or similar enough to be considered as same, function and effects. In this case, it is needless to conduct many experiments on the drug’s pharmacodynamics and pharmacokinetics to show its function and effects. By proving only its bioequivalence only, resources can be diverted to other uses, making the drug approval process more efficient. Thus, the FDA only needs to make sure the generic drug is bioequivalent to its corresponding non-generic drug. As with innovative biologics, the company seeking approval is showing the drug’s bioequivalence to the FDA while the FDA reviews the reports to save government resources

1. If the justifications are successful, then the FDA needs to duplicate only important experiments, and only if the results are the same or similar enough to be considered to be the same, then the proposal can continue.

As one of the main differences with the current approval process for generic drugs, the FDA needs to duplicate important experiments only. This is so that the FDA can make sure that important values are valid as the peer-review process does not always ensure validity of experimental values. Since people would be consuming drugs, these values must be correct.

There are many rooms for drug firms to provide false data and we must take full account of human errors that often occur in non-academic research settings. Also, the peer-review process does not certify the validity of all data, not a regulator does not have the obligation to regulate. Thus, to make sure that values important to the justification are valid, the FDA needs to duplicate only important experiments.

2. If the test of bioequivalence and safety is passed, all experimental details and conclusions are submitted to academic experts that work in universities to seek their safety advice and whether the generic drug is bioequivalent to the non-generic drug. The drugs that FDA scientists think that current science may be overturned by new research or that current science lacks certainty are also submitted by academic experts.

Scientific experts in the field are familiar with these facts. Their review and advice will provide regulators with new facts about safety and bioequivalence that may be important as they can change the drug’s status on its safety and bioequivalence, and affect approval decisions. This can prevent FDA from abandoning rather useful drugs and approving those with newly discovered setbacks.

As a major difference with the current procedure in approving innovative biologics, all experiments, results, and conclusions are presented to academic experts that are at the forefront of research in the academic fields these drugs belong for advice and recommendations on the drug’s safety and bioequivalence. The current methods regulator procedure for approving innovative biologics does not seek these specialists’ advice and recommendations on safety or another aspect of the drugs. Read More