Medical writers can find vast amounts of information about prescription drugs and biologics from a variety of resources, such as scientific publications, electronic databases, and free online content from sites such as drugs.com.
A challenge for medical writing professionals is sorting through these resources to find information that is accurate and acceptable to use as a reference source when writing content that will ultimately go through medical‑legal review.
The most useful and accurate information source that medical writers have access to is the drug’s label, also known as the prescribing information or the package insert (PI). The US Food and Drug Administration (FDA) requires PIs to be included with packages of prescription drugs and biologic products. All of the information included in the PI is supported by substantial evidence and data from clinical trials, which manufacturers provide to the FDA as part of the New Drug Application (NDA) or Biologics Licensure Application (BLA). Data are included in the PI only after they have been reviewed and approved by the FDA. Typically, regulatory writers do not develop PIs, but they may support a team of regulatory and safety experts who lead content development.
PIs contain critical information that helps practitioners and patients understand the usage, risk, and safety of a drug. The current PI format contains two main components: the highlights of prescribing information (HPI) and the full prescribing information (FPI). The HPI appears on the first page of the drug label and briefly summarizes important information about the drug, including boxed warnings, the strongest warning issued by the FDA. A boxed warning alerts prescribers and patients to an increased risk of any serious adverse reactions associated with the use of the drug that could lead to death or serious injury. The information in the HPI is cross‑referenced to the corresponding information within the FPI.
Medical writers should become familiar with the structure and contents of the PI. Each section contains important information about FDA‑approved drugs and biologics that medical writers can use. Let’s take a high‑level look at four of these sections.
The Indications and Usage section of the PI answers the following questions:
Some PIs also have a "Limitations of Use" statement that describes circumstances in which the drug should not be used because evidence suggests that use of the drug would be unsafe or ineffective.
The Dosage and Administration section of the PI answers these questions:
The Adverse Reactions section describes common adverse reactions, including serious adverse events, seen among clinical trial participants, and, if applicable, adverse reactions reported after the drug came to market. An adverse reaction is an undesirable effect reasonably associated with the use of a drug.
Medical writers should always reference the PI when writing about adverse events associated with a particular drug.
Not every study that was part of a product’s clinical development program makes it into the PI. This section of the PI includes only the studies that best represent how the drug is used properly and effectively and that provide evidence to support the labeled indications. The Clinical Studies section contains 3 important subsections:
Once the PI has been written, the document is submitted and finalized through discussions with the FDA during the NDA/BLA review of all the clinical data before a drug is approved for marketing.
Even after a prescription drug is approved by the FDA, the PI may need to be revised from time to time. In some cases, this means adding new data, new formulations, new indications, and new medical findings.
After all that, patients and practitioners get to read the fine print.