Two draft guidances released by the FDA in January 2017 explain the regulations in place for pharmaceutical manufacturers and decision-makers within the healthcare field (eg, payers, formulary committees) that share healthcare economic information (HCEI), and how communications should be handled in the industry with regard to drugs and devices that meet FDA labeling requirements, respectively.1,2Sharing Healthcare Economic Information
According to the FDA, HCEI is classified as any analyses that identify, quantify, or define the economic consequences of the use of a drug.1 It is also possible for these analyses to be comparative to the use of an alternative medication or healthcare intervention, or to no use of an intervention. HCEI is presented in multiple forms, including as a reprinted publication based in a peer-reviewed journal, as an evidence dossier, and as a software package.
The draft guidance pertaining to HCEI is titled “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers,” and addresses common questions related to the HCEI on prescription drugs relayed to payers, formulary committees, and others who are experts in economic analysis by pharmaceutical firms. Answers to popular questions regarding the distribution of information about investigational drugs and medical devices to payers before they receive FDA approval are also provided.
The FDA asserts that, because a large quantity of patients are affected by the coverage and reimbursement decisions that payers develop, information given to payers by drug manufacturers about their agents must be honest and not misleading. Of note, the FDA states that HCEI is false or misleading if it refers to an indication that is not FDA approved.
“To be considered related to an approved indication, HCEI analyses should relate to the disease or condition, manifestation of the disease or condition, or symptoms associated with the disease or condition in the patient population for which the drug is indicated in the FDA-approved labeling,” the FDA stated in its draft guidance.
HCEI analyses that relate to approved indications for their respective drugs include information about practice settings, burden of illness, dosing, length of hospital stay, and validated surrogate end points.
HCEI analyses that are not considered relevant to the approved indication include analysis of disease course alterations that are associated with the treatment of a symptom not deemed relative to the approved indication, and analyses that are based on studies of patients who do not fall into the indicated patient population.
With regard to the type of information pharmaceutical manufacturers should include when distributing their HCEI to payers, the FDA states that appropriate background and contextual information that helps payers fully understand the HCEI should be prominently relayed. An accurate review of the economic analysis design should be communicated, including a statement about the study objectives.Communications Consistent with FDA-Required Labeling
The second draft guidance, “Medical Product Communications That Are Consistent With the FDA-Required Labeling—Questions and Answers,” is a source of information for pharmaceutical manufacturers that divulges how the FDA evaluates the way firms communicate information that is FDA approved but not contained in the FDA-required labeling for a specific drug or device.2
The FDA-required labeling is chiefly the method by which the FDA communicates essential information needed for the safe and effective use of a drug or device, and manufacturers are obligated to keep their FDA-required labeling up-to-date to guarantee that it is not false or misleading. However, this labeling is not supposed to be a comprehensive summary of all available information about a drug or device.
As per the guidance, the FDA regulates whether a communication regarding a drug or device is consistent with the product’s FDA-required labeling based on 3 key factors, including:
- Factor 1—Does the communicated information about indication, patient population, limitations and directions of handling and use, or dosing and administration compare with the information in the FDA-required labeling? If the answer to this is yes, then the communication is not consistent with FDA-required labeling.
- Factor 2—Do the representations and suggestions in the communication increase the possibility of harm to health with regard to the information reflected in FDA-required labeling? If the answer to this is yes, then the communication is not consistent with FDA-required labeling.
- Factor 3—Do the conditions suggested in the communication make it easy to safely and efficiently use a drug or device per the directions for use in its FDA-required labeling? If the answer to this is no, then the communication is not consistent with FDA-required labeling.
Communications that do not fulfill any 1 of these 3 factors are considered inconsistent with FDA-required labeling.Conclusion
These new draft guidance documents from the FDA—both of which are available online through FDA.gov—provide clarity on the sharing of HCEI, and on the consistency of communications from manufacturers regarding their drugs and medical devices with the products’ respective FDA-required labeling.
- US Food and Drug Administration. Drug and device manufacturer communications with payors, formulary committees, and similar entities—questions and answers. January 2017. www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm537347.pdf. Accessed February 27, 2017.
- US Food and Drug Administration. Medical product communications that are consistent with the FDA-required labeling—questions and answers. January 2017. www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm537130.pdf. Accessed February 27, 2017.