AHIP Submits Comment Letters To FDA On Manufacturer Communications
posted by Kevin Fahey
on April 21, 2017
In response to the U.S. Food and Drug Administration’s requests for public comment regarding medical product manufacturer communications, a pair of letters from AHIP Executive Vice Presidents Richard Bankowitz and Matthew Eyles commended the agency for conducting a comprehensive review and providing clarification regarding acceptable forms of communication by manufacturers. The letters emphasized the importance of communication between medical product manufacturers and health plans along with the significant role played by the FDA regarding standards for safety, efficacy, and the supporting evidence.
The full text of the comment letters may be read here and here. Key excerpts are included below:
Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products
- Our member health plans support greater clarity regarding communications between manufacturers and plans regarding off-label uses of approved products.
- Promoting more open communications will provide plans with information relevant to establishing rates and benefits, such as potential expanded indications for existing products, as well as promote visibility into future product pipelines.
- With additional clinical data and information from manufacturers, plans will be better positioned to conduct their own population-based value assessments relative to coverage policies and benefit designs that support value-based health care.
- The FDA’s current requirements for meeting high standards of evidence for safety and efficacy help ensure that robust evidence exists to support approval of drugs, biologics, and devices for specific uses and indications. Health plans believe it is essential that these standards remain rigorous – they should not be weakened in any way and, further, the incentives for manufacturers to go through the FDA approval process be preserved.
- …Off-label marketing through direct-to-consumer (DTC) advertisements poses additional risks to patient and public health. For example, DTC may be misleading, overemphasize a drug’s benefits as compared to risks, and lead to inappropriate prescribing and overutilization.
Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities
- Health plans need sound information to be able to predict anticipated costs for up to several years into the future when making business decisions such as setting rates and contracts. … This information must be based on strong evidentiary standards. … Information on effectiveness, safety, and cost effectiveness, can help plans in drug selection, formulary management, coverage, and reimbursement policies.
- A regulatory framework that enables manufacturers to communicate with plans regarding products that are investigational and under review by the FDA will allow plans to take that information into consideration as they plan for and make coverage and reimbursement policies far in advance of the effective date of the decisions.
- …We encourage the FDA to periodically revisit and reassess the definitions and entities covered by the guidance. It will be important to ensure that the information sharing occurs between sophisticated entities with both a financial and clinical interest to avoid the unintended consequence of affecting prescribing practices by physicians who are directly treating patients.
Kevin Fahey is AHIP’s Executive Director of Special Projects.