How Is Prescription Drug Quality Ensured?

The pharmaceutical drug process, from research and development to approval and production, marketing, sales, and regulatory compliance can be a complex process. Additionally, it may be a fragmented process as well. As many of us take pharmaceutical drugs at least at some point during our lives, you may wonder what is done to ensure the quality of the prescription drugs we take. The Food and Drug Administration (FDA) now includes an Office of Pharmaceutical Quality (OPQ) it intends to help ensure the quality of prescription drugs.

The director of the Center for Drug Evaluation and Research noted that programs exist to ensure drug safety and drug efficacy but drug quality should also receive attention. The OPQ will focus on the quality of prescription drugs throughout the lifecycle of the product. Several existing offices will now all look to the OPQ to head up prescription drug quality assurance.

Concerns surrounding prescription drug quality largely relate to the global nature of the pharmaceutical industry today as well as a described lack of modernization in drug production and prescription drug shortages. As a result, all new drug applications will be reviewed by the OPQ which is now part of the prescription drug approval review process. While quality metrics will have to be submitted to the FDA by pharmaceutical companies, a guidance document for pharmaceutical companies has not yet been released. The director of the CDER notes a belief, however, that pharmaceutical companies will enjoy greater predictability in the application process.

The OPQ does not intend to release the data it collects to the public. When a consumer has suffered a patient injury, or other harm, because of harmful drugs, different remedies may be available to ensure the victim is compensated for the harm suffered. While government regulators, the public, and pharmaceutical companies all seek to ensure the quality, safety, and efficacy of prescription drugs, the pharmaceuticals industry may present challenges for both consumers and drug companies. Knowledge of important regulations can be valuable information for both pharmaceutical companies and the public to understand to protect important interests.

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