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Safety professionals at Johnson & Johnson companies conduct thorough safety assessments as part of the detailed testing of quality, safety and effectiveness before any new product is introduced. Raw materials are assessed for safety and efficacy, and the finished product is reviewed to ensure it works the way it is intended.
We also work to ensure products are used appropriately by monitoring safety data, conducting studies of products in market, educating doctors and other health care professionals on appropriate use of prescription medicines and medical devices, and by helping patients understand how to use health care products wisely. Our operating companies also measure customer satisfaction via surveys, website interactions, focus groups and patient advisory groups.
Safety of Medicines
All medicines have some side effects, and our drug development programs are designed to assure that medicines we bring to market have an acceptable safety profile when used for their intended purpose. Each of our medicines undergoes years of scientific tests before it is approved to determine whether it is safe and effective in treating a particular disorder.
Some safety issues cannot be identified during drug development. Rare adverse reactions may not be detected because the number of patients who participate in clinical testing is much smaller than the number of people who take the drug once it is on the market. Johnson & Johnson companies maintain dedicated staffs of medical professionals who study the safety and efficacy of our medicines after they reach the marketplace and monitor reports of adverse events that are made to regulatory agencies around the world.
Adverse Events Monitoring
Our companies monitor for product issues and known adverse events, and they analyze any novel adverse events that may emerge to better understand them. As required by law, they inform the FDA and other regulatory agencies around the world of adverse events that occur in people who may be using one of our products. In the U.S., drug makers must submit regular reports to the FDA describing the safety experience of people using a medicine. These reports are submitted as often as required, depending upon the specific type of marketing approval and product characteristics, and for all medicines, at least annually.
Sometimes the FDA, or a regulatory agency in another country, requires a manufacturer to conduct additional studies after a drug or device is approved. In the U.S., these are known as Phase IV or ‘post-marketing’ studies. They provide more information about the safety and effectiveness of already-approved health care products. Post-marketing studies can continue for years and involve thousands of patients.
Understanding Safety Issues
Our pharmaceutical research and development organization is a founding member of the Serious Adverse Event Consortium (SAEC), a nonprofit partnership between leading pharmaceutical companies, the FDA and academic institutions. The SAEC is funding studies to identify genetic markers that may help predict people who are at risk for serious drug-related adverse events.