Approval

In the United States of America new pharmaceutical products have to be approved by the Food and Drug Administration to ensure that they are both safe as well as effective. The process does involve submission of the Investigational New Drug filing with sufficient pre – clinical data to support proceeding on to human trials. Following approval there are three larger phases of human clinical trials that may be conducted. Phase 1 generally studies the toxicity using only healthy volunteers. Phase 2 can include Pharmacokinetics and Dosing in patients, then Phase 3 is a very large study of efficacy in the intended patient population. Following the successful completion of phase 3 testing, the New Drug Application is submitted to the FDA. The FDA reviews all of the data then if the product is shown as having a positive benefit – risk assessment, approval to market the product in the US is granted.

There is a fourth phase of post – approval surveillance. It’s also often required because even the largest clinical trials cannot predict the prevalence of all rare side – effects. Post – marketing surveillance will ensure that after marketing the safety of a drug continues to be monitored closely. In some instances, the product may need to be limited to particular patient groups and in others the substance is completely withdrawn from the market. Questions have continuously been raised about the standard of the initial approval process as well as the subsequent changes to product labeling (it can take months and months for any change identified in post – approval surveillance to be reflected in the products labeling) and this is an area that congress is active in.

The FDA provides information about approved drugs at the Orange Book site. In many non – American western countries there is a fourth hurdle that cost effectiveness analysis has developed before the new technologies can be provided. This focuses on the efficiency (in terms of the cost) of the technology in question rather than that of their efficacy. In England NICE approval requires technologies to be made available by the NHS, whilst similar arrangements exist in Scotland with the Scottish Medicines Consortium and the Pharmaceutical Benefits Advisory Committee in Australia as well. A product must pass the threshold for cost – effectiveness if its manufacturers wish it to be approved. Treatments must represent not only some value for the money but also a net benefit to society. There is much speculation that a style of framework modeled after NICE may be implemented in the United States as an attempt to decrease Medicare and Medicaid spending. This would happen by balancing benefits to patients versus profits for the medical industry.

In the United Kingdom, the British National Formulary is the core guide for pharmacists and clinicians.

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