Innovation

Whether the innovative medicine is delivered in a pill bottle, injection, spray or patch, patients around the world can take comfort in knowing that the medicine faced rigorous testing in order to earn approval by the Food and Drug Administration.

America’s biopharmaceutical research companies discover, develop and manufacture medicines and biologics that have helped patients live longer, healthier and more productive lives. The innovation-based industry is driven by science and is highly regulated.

Clinical research is a critical element in the development of revolutionary medicines that help patients. Through carefully controlled clinical studies, researchers thoroughly assess the safety and efficacy of new drug candidates.

The number of experimental medicines in clinical testing today -- more than 2,900 medicines for nearly 4,600 different indications -- represents an all-time high. And America’s biopharmaceutical research companies develop medicines that benefit a worldwide market by conducting clinical trials inside and outside the United States.

What’s more, the FDA has jurisdiction over clinical trials conducted under an investigatory new drug application for medicines approved in the United States or being studied for approval here. The same strict regulatory standards apply to foreign and domestic trials.

Developing a medicine is a long, complex and increasingly transparent process. Innovator companies spend on average 10 to 15 years developing a single medicine. [chart pack link] The clinical portion of drug discovery typically takes up to seven years and includes thousands of patient volunteers throughout several phases of research.

Investigators based in academic medical centers and hospitals around the world lead clinical studies and are selected based on their qualifications, training and expertise in the field, among other factors. If a new medicine is determined to be safe and effective in these trials, the company files a new drug application or biologics license application with the FDA seeking approval. The paperwork for each drug can exceed 100,000 pages.

The research-based biopharmaceutical sector is committed to increasing the transparency of clinical trials sponsored by our companies. As part of PhRMA’s recently strengthened “Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results,” we committed to making data publicly available on the Web. [CT principles link] PhRMA’s commitments exceed existing federal requirements to register clinical trials at ClinicalTrials.gov.

Our companies’ rigorous medical research does not end with FDA approval. Once a product is approved and available to patients, dedicated teams of company scientists and physicians continue to closely monitor the medicine and submit periodic safety reports to the FDA.