About Prescription Medicine

The Food and Drug Administration regulates prescription medicine, and has approved more than 1,000 drugs and biologics for marketing since the Prescription Drug User Fee Act was passed in 1992. The website IMS Health estimates that 4 billion prescriptions were filled and more than $300 billion was spent in the United States in 2009 on prescription drugs. Demand for generic medicines increased from 49 percent to 70 percent between 2000 and 2009, according to the Pharmaceutical Research and Manufacturers of America.

Benefits

Prescription medicines can save lives, reduce symptoms, slow the progression of a disease, prevent diseases and disorders, and reduce health care costs. Prescription medicines has decreased the death rate from AIDS in the United States by more than 70 percent, according to the U.S. Department of Health and Human Services. Research by E. Sun in the Journal of Clinical Oncology showed that prescription medicines increased the survival rates among cancer patients by up to 60 percent since 1975. The use of prescription medicines reduced hospitalization costs for Medicare beneficiaries in 2009, according to research by B.C. Stuart published in Health Services Research.

Investment

The Pharmaceutical Research and Manufacturers of America estimates the costs to develop a drug increased from $138 million in 1975 to $1.3 billion in 2005, and $1.2 billion to develop a biologic in 2005. The biopharmaceutical industry invested an estimated $65.3 billion to develop prescription medicines in 2009. This represented 16 percent of total sales.

Clinical Trials

The FDA requires that biopharmaceutical companies conduct clinical trials on its products to prove their safety and efficacy. Phase 1 studies are on laboratory and animal tests and healthy humans. If the results show the product is safe and has merit, the company must submit an Investigational New Drug Application to the FDA for review, before it can test for safety and efficacy in humans with a particular disease or disorder in Phase 2. If phase 2 shows promising results for efficacy, the company can go onto phase 3 and expand the number of subjects in the studies.

Approval To Market

If results from phase 2 and phase 3 studies are promising, the company can submit a New Drug Application or a Biological License Application to the FDA, to request approval to market the product. The application requires all data in humans and animals that demonstrate how the drug works in the body, plus test results for manufacturing to assure the company will be able to produce the product in compliance with FDA regulations. A team of scientists review the studies submitted in the application to determine whether the product is effective for its intended use and outweighs the risks. If approved, the company can market the product in the United States with the label containing information approved by the FDA.

Misconceptions

Drug development does not end when the FDA approves a product for marketing. The FDA requires pharmaceutical companies to record and monitor reports of adverse reactions and continue to conduct post-marketing studies that support the safety and efficacy of the drug.