As a drugs and society 12 edition study guide pdf of this complex path from discovery to commercialization, partnering has become a standard practice for advancing drug candidates through development pipelines. Governments generally regulate what drugs can be marketed, how drugs are marketed, and in some jurisdictions, drug pricing.
Controversies have arisen over drug pricing and disposal of used drugs. A substance recognized by an official pharmacopoeia or formulary. A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device. Pharmaceuticals may also be described as “specialty”, independent of other classifications, which is an ill-defined class of drugs that might be difficult to administer, require special handling during administration, require patient monitoring during and immediately after administration, have particular regulatory requirements restricting their use, and are generally expensive relative to other drugs. Euthanasia is not permitted by law in many countries, and consequently medicines will not be licensed for this use in those countries. Administration is the process by which a patient takes a medicine.
Despite advances in technology and understanding of biological systems, drug discovery is still a lengthy, “expensive, difficult, and inefficient process” with low rate of new therapeutic discovery. Drug discovery is done by pharmaceutical companies, with research assistance from universities. The drug requires very expensive Phase I, II and III clinical trials, and most of them fail. Small companies have a critical role, often then selling the rights to larger companies that have the resources to run the clinical trials. The regulation of drugs varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as is the case in Australia.
The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population. Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation. In most jurisdictions, therapeutic goods must be registered before they are allowed to be marketed. There is usually some degree of restriction of the availability of certain therapeutic goods depending on their risk to consumers. A third category, “behind-the-counter” drugs, is implemented in some jurisdictions. OTC drugs are sold without restriction as they are considered safe enough that most people will not hurt themselves accidentally by taking it as instructed. In Canada, the Patented Medicine Prices Review Board examines drug pricing and determines if a price is excessive or not.
In these circumstances, drug manufacturers must submit a proposed price to the appropriate regulatory agency. In the United States, drug costs are unregulated, but instead are the result of negotiations between drug companies and insurance companies. High prices have been attributed to monopolies given to manufacturers by the government and a lack of ability for organizations to negotiate prices. 1 billion a year in sales, thus making it the first blockbuster drug.