Product Labeling and Advertising Flashcards

A pharmaceutical company plans to launch a direct-to-consumer (DTC) television advertisement for a prescription drug. According to FDA regulations (21 CFR 202.1), what is a mandatory component of this type of advertisement?

Answer: A "major statement" presented in a clear, conspicuous, and neutral manner, disclosing the major side effects and contraindications.

FDA regulations require that broadcast advertisements for prescription drugs include a "major statement" of the most important risks. This must be conveyed in a clear, conspicuous, and neutral manner. While the ad must make "adequate provision" for viewers to obtain the full prescribing information (e.g., via a website or phone number), the full text is not required in the ad itself. Pre-approval by OPDP is generally not required.

In the United States, regulatory authority over the advertising of drug and device products is divided between the FDA and another agency. The advertising for over-the-counter (OTC) drugs is primarily regulated by which of the following?

Answer: The Federal Trade Commission (FTC)

Through a long-standing agreement, the Federal Trade Commission (FTC) has primary jurisdiction over the advertising of over-the-counter (OTC) drugs, foods, and cosmetics to ensure claims are truthful and not deceptive. The FDA retains authority over the labeling of these products and the advertising of prescription drugs.

Which of the following activities is MOST likely to be considered prohibited "off-label promotion" by a pharmaceutical company representative?

Answer: A sales representative proactively detailing physicians on using their approved analgesic for a new type of pain not included in the Prescribing Information.

A sales representative's role is strictly promotional and limited to the on-label, approved indications for a drug. Proactively discussing or encouraging an unapproved (off-label) use is a clear violation of FDA regulations. In contrast, Medical Science Liaisons (MSLs) can reactively provide truthful, non-misleading scientific information, such as published articles, in response to unsolicited requests from healthcare providers.

A medical device manufacturer is preparing labeling for a Class IIa sterile device to be marketed in the European Union. According to the Medical Device Regulation (EU 2017/745), which of the following must be affixed to the device label?

Answer: The CE mark followed by the four-digit identification number of the Notified Body.

Under the EU MDR, devices that require the involvement of a Notified Body for conformity assessment (including Class IIa, IIb, and III devices) must bear the CE mark followed by the Notified Body's unique four-digit identification number. This signifies that the Notified Body has reviewed and certified the manufacturer's conformity assessment. Class I devices that are not sterile or have no measuring function are self-certified and bear the CE mark alone.

A pharmaceutical company becomes aware of new data confirming a causal link between its marketed drug and a previously unknown serious adverse reaction. To update the Prescribing Information to add a new warning, which is the MOST appropriate regulatory submission to the FDA?

Answer: A "Changes Being Effected" (CBE-0) supplement.

For critical safety-related labeling changes, such as adding or strengthening a contraindication, warning, precaution, or adverse reaction, regulations permit the submission of a "Changes Being Effected" (CBE-0) supplement. This allows the applicant to implement the change immediately upon the FDA's receipt of the supplement, ensuring rapid communication of important safety information. A PAS would require FDA approval before implementation, causing a delay.

According to U.S. FDA regulations for medical device labeling (21 CFR 801), which of the following is a required element on the label of a device intended for prescription use?

Answer: The statement "Caution: Federal law restricts this device to sale by or on the order of a physician" or the symbol "Rx Only".

21 CFR 801.109 specifies that a device restricted to use by or on the order of a licensed practitioner must bear either the full cautionary statement or the symbol "Rx Only" on its label. While the UDI is required on most device labels, it must be in both a human-readable (plain-text) and a machine-readable format. Reimbursement codes and inspection dates are not required label elements.