Prescription Medications and Drug Development Guide
Author: Disabled World (DW)
Updated/Revised Date: 2 Nov 2026
Table of Contents:
Synopsis - Definition - About This Section - FAQs - Publications - Subtopics
Synopsis
An overview of prescription medications, how drugs are defined, named, and regulated by agencies such as the FDA, Health Canada, and the MHRA, plus key drug facts.
At a Glance
- 1 - Most medicinal drugs carry at least three names: a chemical name, a brand name, and a generic name.
- 2 - Streptomycin, discovered in 1943, was the first antibiotic effective against the cause of tuberculosis.
- 3 - A generic drug must be bioequivalent, delivering the same active ingredient to the body at the same rate and extent.
- 4 - A study comparing generics to brand-name drugs found an average difference of only 3.5 percent in absorption into the body.
Topic Definition
- Pharmaceutical Drug
A pharmaceutical drug, also called a medicine, medication, or medicinal product, is a substance used in health care to help diagnose, cure, treat, or prevent disease. Its use in medicine, known as drug therapy or pharmacotherapy, depends on the science of pharmacology for ongoing advancement and on pharmacy for proper management. In the United States, a drug is defined in several ways, including a substance recognized by an official pharmacopoeia, one intended to affect the structure or function of the body, or one meant to diagnose, treat, or prevent disease, with biological products covered under the same broad definition. Because drug discovery and development are complex and costly, governments regulate which drugs may be marketed, how they are promoted, and in some places how they are priced, with national authorities such as the FDA, Health Canada, and the MHRA working to ensure that medicines are safe, effective, and of adequate quality.
Overview
A pharmaceutical drug (medicine or medication and officially medicinal product) is defined as a drug used in health care. Such drugs aid the diagnosis, cure, treatment, or prevention of disease. Drug therapy (pharmacotherapy) is an important part of the medical field and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management. Drug discovery and drug development are complex and expensive endeavors undertaken by pharmaceutical companies, academic scientists, and governments. 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.
In the United States, a Drug is Defined As:
- A substance recognized by an official pharmacopoeia or formulary.
- A substance (apart from food) intended to affect the structure or any function of the body.
- 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.
- Biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process.)
Effective drug regulation for nations both promotes and protects the health of the public through ensuring several things:
- Medicines that are of adequate quality, are safe and efficient are required.
- Health care professionals and patients must have the needed information to enable them to use the medications rationally.
- Medicines must be manufactured, stored, distributed and dispensed in appropriate manners.
- Any illegal manufacture and trade of drugs must be both detected and adequately sanctioned.
- Promotion and advertising of drugs must be balanced, fair and aimed at the rational use of drugs.
- Access to medications must not be hindered by unjustified regulatory work.
National governments are held responsible for the establishment of strong national drug regulation authorities (DRAs) that have a clear mission, realistic objectives, a solid legal basis, an appropriate organizational structure, suitable financing, an appropriate level of qualified staff, equipment and information, access to technical literature, and the capacity to exert effective market control.
DRAs are accountable to both the government and the public at large for their decisions and should be transparent. The DRA's evaluation and monitoring mechanisms need to be built into its regulatory system to assess attainment of its established objectives.
U.S. Food and Drug Administration (FDA)
The FDA protects public health by making sure that human and veterinary drugs, biological products, and medical devices are safe and effective, and that the nation's food supply, cosmetics, and products that give off radiation are safe. It also helps speed up innovations that make medicines and foods safer and more effective, and it gives the public accurate, science-based information about medicines and foods [U.S. Food and Drug Administration, n.d.].
Health Canada
Health Canada is the federal regulator of drugs and health products in Canada. It weighs the potential health benefits of drugs and health products against their risks, treats public safety as its highest priority, and works with other levels of government, health professionals, patient and consumer groups, researchers, and manufacturers. Health Canada does not make or sell drugs; for advice about treatment options or where a product is sold, people should talk to a health professional or contact the company directly.
Medicines and Healthcare products Regulatory Agency (MHRA) - U.K.
The MHRA is the U.K. government agency responsible for making sure that medicines and medical devices work and are acceptably safe. No product is free of risk, so the agency judges whether the benefits to patients and the public justify the risks. It keeps watch over medicines and devices after they reach the market, acts quickly to protect the public when there is a problem, and encourages patients, health professionals, and industry to report concerns about a medicine or medical device.
Medication Naming
Drug names are given according to a scheme in which certain syllables, called stems, show the chemical structure, action, or use of the drug. In the United States, three main groups are involved in naming medicines: pharmaceutical companies, the FDA, and the U.S. Adopted Names (USAN) Council. The World Health Organization (WHO), the International Union of Pure and Applied Chemistry (IUPAC), and others also play roles. Many medicines have at least three names:
- The chemical name describes the exact structure of the molecule, following IUPAC rules.
- The brand name is created by the company that makes the drug.
- The generic name is the name of the active ingredient.
Generic and brand names must be unique, so that one drug is not mistaken for another when it is prescribed or dispensed. A generic drug must be bioequivalent to the brand-name product, meaning it contains the same active ingredient and delivers it to the body at the same rate and to the same extent. A study that compared generics to brand-name drugs found, on average, only a 3.5 percent difference in absorption into the body.
Medication Facts
- Sulfa drugs, the first widely used antibacterial medicines, appeared in the 1930s. Penicillin, which came into wide use in the 1940s, worked against a broader range of bacteria with fewer side effects.
- Streptomycin, discovered in 1943 at Rutgers University, was the first antibiotic effective against the bacterium that causes tuberculosis.
- Competition from generic drugs lowers prices: a single generic competitor can lead to price reductions of about 30 percent, and five competing generics are associated with price drops of nearly 85 percent [U.S. Food and Drug Administration, 2021].
- Biosimilars are biologic medicines that are highly similar to an approved biologic, with no meaningful differences in safety or effectiveness.
- Prescription drug prices in the United States are higher than in most other high-income countries.
Frequently Asked Questions
What is the difference between a brand name and a generic drug?
A brand name is created by the company that developed the drug, while a generic uses the name of the active ingredient and must be bioequivalent to the brand version, meaning it is chemically similar.
Are generic drugs as safe and effective as brand name drugs?
Generic drugs must meet the same quality and bioequivalence standards as their brand name counterparts, so they are considered to work in the same way while often costing less.
Why are prescription drugs so expensive in the United States?
Prices reflect high research and development costs, lengthy approval timelines, marketing spending, and a regulatory environment where drug pricing is largely left to the market rather than centrally controlled.
How long does it take for a new drug to be approved?
Bringing a new drug from early laboratory work to approval commonly takes well over a decade, reflecting the many stages of testing and review required to confirm safety and effectiveness.
What is the difference between a drug and a biological product?
Both are covered by similar laws, but drugs are typically made through chemical processes while biological products are produced through biological processes, which affects how they are manufactured and regulated.
What are clinical trials and why do drugs need them?
Clinical trials are structured studies in people that test whether a treatment is safe and effective, and they provide the evidence regulators need before a drug can be approved for wider use.
How should you find out about drug interactions and precautions?
Information about interactions and precautions is available from your pharmacist, your prescribing healthcare professional, and official medicine labeling, which should be reviewed before combining medications.
What is a biosimilar?
A biosimilar is a biologic medicine that is highly similar to an existing approved biologic, with no meaningful differences in safety or effectiveness. Biosimilars often cost less and can increase access to treatments such as insulin and arthritis drugs.
References
- U.S. Food and Drug Administration. (n.d.). What we do.
- U.S. Food and Drug Administration. (2021). Generic drug facts.
Curated and edited by Ian C. Langtree, Founder and Editor-in-Chief, Disabled World. This section is maintained by the Disabled World editorial team. Last updated: