Question

Why is prescribing information, i.e., a fully detailed product label, required only for marketing applications, NDAs/BLAs, and not for INDs, i.e., investigational drug applications?

Answer 1

Ans) Prescribing information is also called product information, product labeling, or the package insert ("the PI"). It is generally drafted by the drug company and approved by the FDA. This information travels with a drug as it moves from the company to the pharmacist.

- Broadcast ads can meet the "adequate provision" requirement by giving a number of sources for finding a drug's prescribing information. These include:

• A healthcare provider (for example, a doctor)
• A toll-free telephone number
• The current issue of a magazine that contains a print ad
• A Web site address

- Drugs that have special problems, particularly ones that may lead to death or serious injury, may have this warning information displayed within a box in the prescribing information. This is often referred to as a "boxed" or "black box" warning. Drugs that have such boxed warnings are not permitted to have reminder ads.

- It includes the details and directions healthcare providers need to prescribe the drug properly. It is also the basis for how the drug company can advertise its drug.

The prescribing information includes such details about the drug as:

Its chemical description
How it works
How it interacts with other drugs, supplements, foods, and beverages
What condition(s) or disease(s) it treats
Who should not use the drug
Serious side effects, even if they occur rarely
Commonly occurring side effects, even if they are not serious
Effects on specific groups of patients, such as children, pregnant women, or older adults and how to use it in these populations.