Drug approval news is a major source of information about new treatments for patients. But the quality of print media coverage and the variety of sources on the Web mean that consumers may not be receiving all of the information they need to make decisions about which drugs to take and how to use them. This research analyzes the quality of print and online resources that present information about drugs approved by the Food and Drug Administration (FDA). It finds that while FDA press releases provide more accurate and complete information than newspaper articles, the quality of online resources varies widely.
The FDA’s new policy on biosimilar medicines aims to break down barriers to reducing prices for the most expensive medications in the United States, which are typically two-to-three times higher than in other countries. The reforms will allow developers to make cheaper versions of biologic medicines, which are produced with living cells and are more complex than chemically derived drugs. These medicines are designed to treat serious diseases, including cancer and autoimmune conditions.
The FDA recently approved Johnson & Johnson’s new medication CAPLYTA (lumateperone) as an adjunctive therapy in adult bipolar I and II depression and for schizophrenia. CAPLYTA is the first drug under J&J leadership to be approved under the Orphan Drug Designation, which allows for expedited review of drugs that affect less than 200,000 patients. Despite the orphan drug designation, further studies are needed to demonstrate that these medicines add therapeutic value and benefit patients.
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