Drug

A drug is a substance that cures, treats, prevents, or reduces the symptoms of a disease or ailment. Patients can take drugs orally as a tablet or liquid, by injection into a muscle or vein, by absorption through the skin, via nasal inhalation or through a number of other methods. In the United States, drugs are regulated by the Food and Drug Administration (FDA), and its Center for Drug Evaluation and Research (CDER) acts as a consumer watchdog. Because drugs are such big business, some unscrupulous companies produce counterfeit drugs. These are illegal; at best, they may be ineffective, and at worst they may be deadly.

The drug development process has five phases:

1. Development and Discovery
2. Preclinical Research
3. Clinical Research
4. FDA Review
5. Post-Market Safety Monitoring

In the development and discovery phase, the company’s researchers explore new avenues for medication development. These can include investigating unexpected effects of existing drugs; testing new molecular compounds; or creating new technology that allows medical products to work differently in the body. Researchers must determine dosage, method of administration, side effects, drug interactions, effectiveness and the drug’s absorption, metabolization and excretion in this phase.

Next, the company must conduct tests to determine whether the drug is safe and effective for use in humans. The company first tests the substance in the lab (in vitro) and sometimes on animals or other living things (in vivo) before deciding whether it makes sense to test it on humans in clinical trials. If tests on humans show the drug to have a medical benefit and to be safe, the company submits the evidence to the CDER, which then employs pharmacologists, chemists, statisticians, physicians, and other scientists to conduct an independent and unbiased review that usually takes six to ten months. The drug company will be allowed to sell the drug if the CDER determines that the drug’s benefits outweigh its risks.

Drugs can be name-brand or generic. Name brand drugs are patent-protected. Once a drug’s patent expires, other manufacturers are allowed to produce and market generic equivalents of that same drug. Generic drugs must have the same therapeutic effect as the name-brand equivalents to receive FDA approval to market and sell them as substitutes, but may sometimes be made with different inactive ingredients, so patients with allergies or other concerns may need brand-name versions.

For pharmaceutical companies, drug development and testing is an expensive undertaking, and while a successful drug can be highly profitable, those profits must be high enough to balance out the losses from all the failed drugs it did not bring to market. Failures in drug development are much more common than successes.