Marketed drug products require a collection of medical response letters which address different subjects pertaining to a drug’s proper usage and administration, safety, efficacy, use in special populations (pregnancy; pediatrics; elderly; compromised kidney or liver function) and additional topics. Upon a drug’s launch, these letters are prepared but over time they require updating based on new clinical information which expands the breadth of knowledge about a drug. It is common practice to update letters as well as create new ones.
A recent assignment for Dr. Wells was to edit an existing medical response letter on chemical stability of a drug product. Using his knowledge of analytical chemistry, he was able to read the original chemistry reports and interface with analytical staff to have meaningful discussions and interpret the available information. As a result, the chemical stability of this drug after reconstitution was able to be extended and the updated letter no longer had gaps in its information that were unexplained. Stability of the drug product in conditions of extreme heat and cold was also updated and the range was extended. Updating medical response letters is a common project, as well as writing new letters. Dr. Wells has 31 years of experience as a pharmacist and can quickly become a Subject Matter Expert on marketed drugs, including esoteric ones such as orphan drugs.