On December 10, 2014, the FDA published industry guidance (Guidance) targeting the Patient Counseling Information (PCI) section of the Physician Labeling Rule (PLR) regulations. 79 FR 73322; FDA-2013-D-1067-0004, available at www.regulations.gov (The FDA’s December 10, 2014 guidance finalizes the draft guidance issued on September 18, 2013, without substantive change. 78 FR 57394).

The PCI section provides information to a health care provider about what information the health care provider should directly communicate to the patient after the decision to prescribe the drug has been made.

According to the Guidance, the PCI section should summarize the information most important to the patient in taking the medicine; it should set that information out in the order of greatest clinical importance to the patient, focusing on the “most important adverse reactions applicable to the patient” and any information that will affect the patient’s compliance with the treatment regimen. The Guidance provides the following examples of the types of information that should be included in the PCI section:

  • Black Box warnings and risk information from the “Warnings and Precautions” section of the label but not all possible side effects
  • side effects that require the patient to take action (e.g., discontinue use or seek medical attention)
  • side effects that might affect compliance with the treatment plan (e.g., development of a cough from the use of angiotensin-converting enzyme inhibitors)
  • drug interactions or food interactions that are in the patient’s control (e.g., over the counter medications, alcohol use)
  • unique storing and handling instructions (e.g., do not crush this pill) but not general dosing instructions

FDA’s position that the PCI should focus on the risks and other information “most important” to the patient puts into question whether a manufacturer’s decision not to include a particular risk factor in the PCI section will affect the manufacturer’s ability to rely on some jurisdictions’ versions of the “learned intermediary” rule.

The learned intermediary doctrine is based on the fact that a prescribing physician has an independent duty to evaluate the risks and benefits of a drug and convey that information to the patient.

In recent years, many drug manufacturers have faced the argument that a direct-to-consumer advertisement negates the learned intermediary doctrine because the drug company, not the physician, was responsible for the content of the risk/benefit information the plaintiff patient received.

The FDA’s guidance concerning PCI may facilitate a similar argument in future cases:  because the PCI guidance makes the manufacturer responsible for identifying and prioritizing the warnings a physician must pass on to the patient, the physician’s independent duty to communicate the risks of the treatment plan may be negated or limited to the information identified on the PCI.

Such an argument, however, would be a gross oversimplification of the PLR labeling requirements. The PCI section is only one of 17 required physician-directed label sections that contain extensive information on risks, contraindications, and other considerations directed at prescribing physicians. Moreover, the FDA notes that the PCI section itself is not a script for the health care provider to follow, but is simply intended to facilitate the provider-patient discussion.

Nevertheless, in determining what information to include in the PCI, drug manufacturers would be well advised to analyze this section with an eye toward identifying known risks, foreseeable misuse, and other factors that may become disputed issues in future litigation.