On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
Less is More in FDA’s Eyes: FDA’s Revised Draft Guidance on Disclosing Risk Information
Traditionally, manufacturers of prescription drugs have satisfied the brief summary requirement by including the complete risk-related sections of the prescribing information (PI) in DTC print ads and been exempted from the adequate direction for use requirement for labeling by appending the PI to any product materials. FDA “strongly recommends against” these traditional approaches in this new guidance, citing research regarding consumer comprehension and recall of prescription drug labeling. See Revised Draft Guidance, at 4-5. The agency explains that consumers lack the technical background to understand the risk information in the PI and often do not read it in its entirety.
FDA proposes in the guidance that manufacturers adopt alternative approaches to the brief summary in DTC print advertising and to inclusion of the full PI in consumer-directed promotional labeling. (Incidentally, this is the second time this year that FDA has recommended against including a paper copy of the PI in contexts where it has traditionally been included. See our previous blog post about electronic distribution of PIs. The agency suggests only providing certain information to satisfy these requirements, including, but not limited to:
- Boxed Warning
- All Contraindications
- Certain Warnings, Precautions, and Adverse Reactions
- “Clinically significant” drug interactions
- Information patients should discuss with their provider
- A statement (1) reminding consumers the information is not comprehensive, (2) suggesting that consumers speak to their provider or pharmacist, and (3) containing a toll-free phone number or website address to obtain the FDA-approved product labeling
The revised draft guidance does not clearly address which Warnings and Precautions should be included, as it only provides certain examples of references that may be used for determining whether to include information. Though the PI Highlights section is one of these references, the revised draft guidance specifically states that the summary should be more detailed and provide more material information than what is contained in the Highlights section. See Revised Draft Guidance, at 7. The guidance also recommends that risks be presented in consumer-friendly language and use presentation mechanisms (e.g., headings, sub-headings, bullets, more white space, text boxes) to improve consumer use.
The principles underlying these recommendations mirror the earlier 2004 draft guidance on disclosure of risk information, however, the agency recommends in the new guidance two alternative formats. One format proposed is a prescription Drug Facts box, which would have information appear in a box similar to the OTC Drug Facts box. The other format would simulate a dialogue by presenting information in the form of questions and answers (e.g., “What Warnings should I know about [drug]?”), much like Medication Guides or patient labeling formats.
Given the tension between FDA’s recommendation in the draft guidance to include less risk information and product liability concerns, we recommend that companies vet new DTC brief summaries and alternatives to the PI for consumer labeling with OPDP and products liability counsel, and consider pre-clearance with OPDP to get clarity on what information should be included in the brief summary.
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