Medical Product Communications: Industry Seeks to Reform FDA Draft Guidances

With a flood of new comments, pharmaceutical, biotech and medical device companies are seeking changes to two draft guidances explaining the US Food and Drug Administration's (FDA) evolving policies on industry communications with payers and claims that adhere to a drug's label.

Introduced in January, the draft Q&A documents detail how drug and device firms can discuss unapproved medical products with payers in ways that are "truthful and non-misleading," as well as in ways that are consistent with the FDA-required labeling.

AbbVie encouraged FDA to combine the two drafts, as there is some overlap between them and differences that may lead to divergent interpretations and confusion for both firms and the agency.

"The Payor Guidance, for example, permits product communications 'related to an approved indication' supported by 'competent and reliable scientific evidence'—standards derived from Section 114 of the Food and Drug Modernization Act ('FDAMA 114'), as amended. Conversely, the Medical Product Communications Guidance permits product communications 'consistent with the FDA-required labeling' supported by 'scientifically appropriate and statistically sound' evidence, but these standards are not tethered to any statutory mandate," AbbVie said.

Docket for Draft Q&A on Communications with Payers

Eli Lilly and insurer Anthem came together to submit a joint comment on the payer Q&A, noting that changes to the existing FDA regulations and policies "are necessary in order to mitigate the challenges associated with the limited information that currently exists during insurer rate development and stakeholder budgeting timelines."

The two companies also seek clarity on whether FDA views pre-approval communications as promotional, and they call for the guidance to cover not only new molecular entities but also new indications and line extensions (NILEX).

"As indication-based pricing becomes more of a reality for certain products, some NILEX indications may require additional modeling by payors due to substantial differences from currently improved indications and the FDA should provide flexibility to enable provision of such information where it is necessary for payors planning and forecasting."

Industry group BIO, meanwhile, noted the "inherent limitations" to relying solely on the approved product labeling for treatment information, quoting FDA commissioner nominee Dr. Scott Gottlieb's explanation that, "[b]y definition, prescribing decisions made solely on the basis of FDA-approved labeling would be made according to evidence that excludes the most-up-to-date clinical data, thereby denying patients important opportunities to get access to the latest clinical practice and for doctors to tailor each patient's treatment plans based on the most up-to-date scientific information (information often not reflected in the FDA-approved labeling)."

"Payors and HCPs also are interested in scientifically robust information including information about the pharmacoeconomics of the therapy, its potential impact in patient subpopulations, sound comparisons to the standard of care, its potential role in a multi-component treatment regimen, and the utility of any particular therapy," BIO added, saying that it "does not believe that FDA's modernizing its current framework to appropriately broaden communications will detract from the sound incentives for pursuing label expansions."

Medical device industry group AdvaMed sought to distinguish differences between such communications for pharmaceutical and device companies.

"Importantly, we note the review cycle for medical device reimbursement and utilization decisions frequently requires communications with payors, technology assessment committees, and similar entities about products during the period after a premarket submission has been made but before approval or clearance is received. The Guidance recognizes communications with payors, formulary committees, or similar entities. However, the review cycle for medical device reimbursement and utilization often requires discussion with other persons within health care systems, including health systems' budget committees and technology assessment committees."

For improved clarity, AdvaMed recommends the addition of "value committees" in addition to "technology assessment committees," which are focused on value review rather than product review, as well as "buyer committees (e.g., group purchasing organizations)" and "stakeholder coding committees (e.g., AMA CPT Editorial Panel)" to better incorporate those that review medical technologies to make coverage and reimbursement decisions.

Docket for Q&A Draft Guidance: Medical Product Communications Consistent With Labeling

Both AbbVie and industry group PhRMA said that FDA needs to revise this draft Q&A to clarify that it's for promotional communications.

AbbVie says: "With respect to the Medical Communications Guidance, FDA should delete those parts of the Guidance suggesting that the agency intends to regulate speech constituting 'scientific exchange' as opposed to promotional communications, and clarify how certain information may be communicated under FDA's regulations when not supported by 'substantial evidence.'"

PhRMA echoes that sentiment, calling on FDA to address scientific exchange elsewhere: "To the extent FDA wishes to establish policies to clarify its approach to non-promotional scientific exchange, PhRMA recommends that the Agency do so by establishing a robust framework via a separate rulemaking or guidance."

And although PhRMA says it agrees generally with the standard in the draft that communications must be supported by evidence that is "scientifically appropriate and statistically sound," it would be helpful for FDA to provide more guidance "on the sorts of data that would meet this standard in recognition that, because it is a new standard (i.e., not otherwise defined by statute, in case law, or in other regulatory constructs), it is challenging to interpret and apply the standard in a precise manner."

In addition, Pfizer calls on FDA to acknowledge that a "manufacturer's communication of reliable medical information about possible ways to manage necessary dosing modifications or interruptions would be deemed consistent with label."

And Genentech encourages FDA revisions that: "(1) clarify that information about use of products in conjunction with other products and therapeutic modalities may be consistent with the label; (2) reflect that firms' communications of information that is consistent with the FDA-required labeling are not considered evidence of a new intended use; and (3) develop an optional advisory comment process for firms seeking to apply the Draft Guidance."