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# Lilly, Anthem Offer Communication Clarifications
- URL: https://www.fdaweb.com/lilly-anthem-offer-communication-clarifications/
- Published: 2016-02-11T12:00:00.000Z
- Updated: 2026-09-15T02:35:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134736

> Eli Lilly and Anthem, Inc. health plans are proposing clarifications to federal law to confirm that drug manufacturers may speak openly with health plans about drugs going through the FDA approval process. The proposal would particularly relate to information on product efficacy, safety, and pharmacoeconomics.  
>  
> A [statement](http://thinkanthem.com/sites/default/files/ProjectIndy%5FFDACommunication%5F1.29.15%5Fv2.pdf?ref=fdaweb.com) from the two companies says that with FDA’s new breakthrough therapy designation, blockbuster drugs are likely to move more quickly through the approval process, meaning that health plans, employers, and state and federal governments will have less time to plan for using the drugs. Breakthrough drugs can have significant budget impacts on health plans, employers, and state and federal government entities, the paper says, especially since rate decisions must be made well in advance of a coverage year.  
>  
> “Clarifying that manufacturers and health plans may discuss critical scientific evidence and other drug features (e.g., dosage, pharmacoeconomic information, and clinical indications) for products under FDA review would encourage those discussions,” the two companies say, “allowing health plans to better anticipate effects on the target patient population and consider available pharmacoeconomic and efficacy data.”  
>  
> The paper notes that current rules prohibit manufacturers from communicating promotional claims of a drug’s safety or efficacy for an investigational use, and manufacturers must avoid commercialization of a product before it is approved for commercial distribution. “FDA’s chief concern is that such communication may undermine the approval process, as products’ safety and efficacy are not considered to be established until FDA grants marketing authorization,” it says. “Further, FDA is concerned that pre-approval communication could create confusion if stakeholders share safety and efficacy information that is not ultimately included in the FDA-approved label.”  
>  
> The companies respond that targeted pre-approval conversations between manufacturers and health plans are not inherently promotional, and in the absence of definitive negotiations or a signed agreement, such conversations would not amount to commercialization. “In any event,” they say, “use of a medical product would not be allowed prior to FDA approval. While such conversations are not clearly covered or prohibited by existing legislation and regulations, ongoing concerns about FDA’s interpretation have a chilling effect on industry and create a compelling need for clarification.”  
>  
> There are several practical considerations involved in implementing such a policy, Lilly and Anthem conclude. First, stakeholders such as FDA, manufacturers, and health plans would have to define the specific types of information that are critical to inform desired discussions. They say they expect that applicable information would include data from pivotal Phase 3 clinical trials, supported by substantial evidence, or pharmacoeconomic data, supported by competent and reliable evidence. Stakeholders also would have to consider what limitations and parameters should guide the discussions, such as restricting it to indications undergoing FDA review, communications within a specified time of the expected PDUFA date, confidentiality restrictions, and disclaimers.