by Karl Kapp
In January, the FDA released two separate draft guidances that provide clarity for medical product companies, as well as other interested parties, on FDA’s current thinking and recommendations for a few different types of communications about medical products.
The first draft guidance is “Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities” :
This draft guidance provides answers to common questions regarding the communication of health care economic information (HCEI) about approved prescription drugs by medical product manufacturers, packers, distributers, and their representatives (firms) to payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis (collectively referred to as payors). This draft guidance also provides answers to common questions about firms' communications regarding investigational drugs and devices (investigational products) to payors before FDA approval or clearance of such products. The Agency is issuing this draft guidance to explain FDA's current thinking on frequently asked questions regarding such communications in order to provide clarity for firms and payors.
The second draft guidance is “Medical Product Communications That Are Consistent With the FDA-Required Labeling” :
This draft guidance provides information for manufacturers, packers, and distributors and their representatives (collectively “firms”) of drugs and medical devices for humans, including those that are licensed as biological products, and animal drugs (collectively “medical products”), about how FDA evaluates their medical product communications, including their promotional materials, that present information that is not contained in the FDA-required labeling for the product but that may be consistent with the FDA-required labeling for the product. The Agency is issuing this draft guidance to explain FDA's current thinking on commonly asked questions regarding such communications in order to provide clarity for firms.
The FDA has opened a public comment period for each draft guidance and seeks input from a broad range of stakeholders. If these drafts affect your organization, now would be the time to provide input. To ensure that the FDA considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 19, 2017.