In the light of the forthcoming reforms of the Ukrainian healthcare system, it is important to identify the best world practices and introduce the most progressive approaches to the domestic drug supply system. Unthinking copying of someone else’s experience or rash hasty steps can lead to a decrease in the effectiveness of drug provision for patients. This article examines the regulation of the circulation of original and generic medicines in the United States, as well as changes in the status of drugs. How does the US control the effectiveness and safety of medicines?
For the first time, a consolidated register of medicines marketed in the US market was published in the late 1970s. In 1984, the US president signed the law “On price competition in the field of drugs and restoration of the validity of patents” (Drug Price Competition and Patent Term Restoration Act). According to this document, the FDA, among other things, should publish a list of approved medicines, updating it once a month. The Drug and Cosmetic Regulatory Consultants can guide you in that matter.
Today this edition is probably the best world practice of keeping a register of registered drugs, allowing all interested parties to make sure that a particular marker drug is characterized by proven efficacy and safety, and in the case of generics, based on a study of the therapeutic equivalence of generic drugs.
In the United States, drugs in most cases are allowed to enter the market in 2 procedures:
- Application for registration of a new drug (New Drug Application – NDA). This procedure is applicable to new medicines that are first introduced to the US market.
- Application for a shortened procedure for drug registration. This procedure is applicable when registering generic medicines.
With the help of the application (registration certificate) of the NDA, companies are introducing innovative drugs to the US market. Data from pre-clinical animal studies and clinical trials involving patients and healthy volunteers included in the package of documents (registration certificate) of the experimental new drug (Investigational New Drug-IND) become part of the NDA.
The generic preparation is defined as an analogue of an innovative (original) preparation for such parameters as dosage, form of release, concentration of the active substance, mode of administration, quality, technical characteristicsand indications for use.
Consider the structure of Orange Book. This edition consists of 4 sections:
- Approved prescription drugs with proven therapeutic equivalence.
- Preparations approved in accordance with the legislation regulating the circulation of biological products.
- Aggregate list of drugs: approved, but never marketed on the market; for military needs; intended for export; withdrawn from the market. Registration of which was canceled due to the revealed lack of efficiency or insecurity.
- Specificity of maintaining this register of medicines is due to the drug supply policy implemented in the United States.
Thus, the implementation of measures to curb the growth of health care costs, in particular, the implementation of a generic replacement, is possible only if the patient is provided with a drug similar to the original drug (in terms of quality, safety and effectiveness).