Pharma Gains Marketing Flexibility, Loses Exclusivities in Revised “Cures” Proposal

Amidst its multiple proposals for stimulating drug development and revising regulatory processes, the 21^st Century Cures initiative includes provisions that provide more flexibility in drug communications and product development. Pharma marketers have been pressing hard for FDA to clarify how they may communicate economic information to formulary committees & other knowledgeable entities; now the legislative plan from the House Energy & Commerce (E&C) Committee proposes to permit companies to discuss economic issues based on “competent and reliable scientific evidence” to payers, formulary committees and other “similar” economic entities.

The revised Cures discussion draft also makes it easier for pharma companies to distribute journal articles and medical textbooks to physicians by making it unnecessary to report those items as transfers of value to physicians under the Sunshine disclosure program. Also off the disclosure list is some payments to speakers at non-promotional educational events.

These proposals are raising eyebrows at FDA. Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), expressed concern about giving pharma companies too much leeway in distributing information about off-label drug uses. There are multiple pathways for clinicians to get information  about drugs, and clearly “a downside” to establishing a market for a drug before it is adequately tested, she commented at the E&C hearing April 30.  And in response to a query about why FDA doesn’t let sponsors “tweet” about a new drug with a link to full safety and efficacy information, Woodcock observed that manufacturers have “a different stake in presenting information than the agency.” She agreed to work with the legislators to develop a “common-sense” approach to social media communications about drugs.

Another provision in the draft bill slated for further discussion is one that allows biopharma companies to use “clinical experience” rather than data from randomized trials to support new indications. The proposal also permits FDA to quickly approve expanded uses based on data summaries, rather than the full data package.

But the main concern for Woodcock and her colleagues is that the legislators require FDA to establish new programs and issue more guidance without providing any additional resources. This latest E&C proposal has “significant resource implications for FDA,” Woodcock stated, pointing out that added mandates could divert resources from application review and biomarker development. CDER’s new drug review process is now “going at full speed, and we’d like to keep it that way,” Woodcock commented, noting that “there’s always a trade-off” in putting out new guidances and getting reviews done. Being able to offer timely advice to biopharma companies helps accelerate new drug development, she noted, but support for multiple advisory meetings “would be the first to go” if the agency gets further stretched on resources.

The main downside for pharma is that this slimmed-down version of the Cures legislation drops a number of earlier provisions that provided added exclusivity for certain new therapies. E&C Republicans indicated they may seek ways to restore some of these incentives for developing important new drugs, but there’s strong opposition from many Democrats.

Agreement to limit new exclusivities, plus a significant boost in funding for the National Institutes of Health (NIH), prompted Democrats to support the draft proposal. The new E&C plan gives NIH an added $5billion in funding over three years, boosting its budget to $35 billion in 2018. And there’s another $2 billion a year to support an NIH Innovation Fund. With bi-partisan support, some kind of compromise measure could see legislative action by summer.