On January 22, the US Food and Drug Administration (“FDA”) finalized its guidance on the content and format that drug manufacturers should use to warn physicians of newly-discovered risks.   These letters are referred to as “Dear Health Care Provider letters” by the agency and “Dear Doctor Letters” colloquially and are correspondence ― often in the form of a mass mailing from the manufacturer or distributor of a human drug or biologic or from FDA ― intended to alert physicians and other healthcare providers about important new or updated information regarding a human drug or biologic.  The guidance, entitled: “Dear Health Care Provider Letters: Improving Communication of Important Safety Information,” provides recommendations on when to issue a letter, the types of information that should be included in the letter, how to best organize the information so that it is communicated effectively to the physicians, and the best formatting techniques to make the information more accessible.

The guidance removed a controversial provision that would have required pharmaceutical companies to determine the impact of their letters on health care providers and patients.  Instead, there is now a suggestion that assessments be performed for internal company use.  The agency also used this guidance to explain how letters to doctors should be structured in order to attract attention to ensure that physicians learn about the new warnings.  For example, FDA is suggesting that letters be two pages or less, have bold-faced subject lines, and have subject lines with strong wording that quickly makes clear the risks of a given product.  The letters also should not focus on non-critical information as such information could obscure the essential material.  The agency wants letters to begin with a quick summary of the new risks, describe patient populations that are particularly at risk, provide statistics to highlight the degree of risk, and stipulate whether physicians should take any specific action.  The letters to physicians must also notify the physicians about how they can promptly report adverse events to drug companies and the agency.