Drug Safety

When it comes to medicines, safety means many things to many people. Volunteers in clinical trials, researchers and technicians working in laboratories and manufacturing facilities, regulators at the food and drug Administration physicians prescribing medicines, and patients who rely on those therapies to lead healthier, longer lives -- all have vested interests in safety. Nothing is more important to America’s biopharmaceutical research companies than the safety and integrity of the medical products they develop.

Ensuring the safety of a medicine begins long before a therapy enters the marketplace and continues long after it is available to patients. During the discovery and development

 of a potential medicine, safety is established incrementally through laboratory tests, studies with small numbers of volunteer patients, and carefully controlled and monitored clinical trials.

Throughout the review process, the FDA evaluates new medicines to determine that the health benefits outweigh emerging risks. And biopharmaceutical research companies, the FDA, healthcare providers and patients all play crucial roles in monitoring the safety of approved medicines.

According to the FDA, about 97 percent of the medicines it has approved over the past two decades are still on the market and considered safe. While this is a solid collective track record, America’s biopharmaceutical companies continuously strive to make a good system even better.

The proper use of medicines also is a critical element of patient safety and something that companies continue to stress. Innovative medicines can extend and enhance patient lives, but they also can be dangerous if misused or abused. Promoting adherence to prescribed treatments, reducing prescription drug abuse, and fostering prompt and safe disposal of unused medicines are ongoing priorities for biopharmaceutical research companies and other healthcare stakeholders.

Member companies also continue to work with key government agencies, such as the FDA and Homeland Security Department, and with congressional leaders to help safeguard patient health and the U.S. drug supply.

Although America’s medicine supply remains the safest in the world, no country is immune to the global threat of counterfeit medicines. The most common means forcounterfeit drugs to enter the United States is through purchases made on illegal online pharmacy websites operated by criminals in countries that have known counterfeiting problems. Targeting these illegal websites can help protect patient safety and ensure that the closed U.S. drug-supply system is not compromised.