FDA Needs ‘Regulatory Competitiveness’ Official: ex-FDAer
FDA needs a deputy commissioner for regulatory competitiveness to “aggressively develop, coordinate, and drive agency initiatives that allow new medical products and technologies to come to market faster and less expensively — without sacrificing sound regulatory science.” So argues former FDA associate commissioner for external relations and now Center for Medicine in the Public Interest president Peter Pitts in a Health Affairs blog post.
Pitts says too many see the agency as hindering innovation and it needs to become an “innovation accelerator and a competitiveness enabler.” The deputy commissioner would help to ensure that “therapeutic monopolies are not allowed to continue years after patent expiry and that regulatory ambiguity (across the entire portfolio of FDA responsibilities) would not stymie investment or innovation,” he writes.
The blog post also recommends that under the new structure, a competitiveness designation would be scored to “rank product applications (generic, non-biologic complex drug, drug, biologic, biosimilar, medical device, combination product, vaccine, and so forth) that have the potential to impact free-market forces within a therapeutic category. A good score on this metric could lead to a ‘competitiveness designation,’ providing a product with an expedited review pathway similar to those currently offered for advances in specific advances in therapeutic care.” Other benefits for highly scored applications could mean more FDA resources assigned to get the product to market or an expedited parallel FDA/CMS review to help speed up reimbursement decisions, according to Pitts.
Current expedited pathways, Pitts continues, reward investment in targeted therapeutic areas. He says the aim of the proposed competitiveness designation would be to “incentivize development programs that significantly impact the free-market dynamics of the health care marketplace, thereby enabling marketplace competitiveness. Examples of such products might include a generic alternative to corticotrophin (a very high-cost product that is off-patent but has no generic alternatives) and chemically synthesized insulin analogs.”
Pitts believes the 21st Century Cures Act gives FDA the authority to use new science to speed product development and review. “It also directs the agency to advance and evolve how the products under its jurisdiction are measured for both safety and effectiveness once approved and on the market,” he contends. “But the uptake of new pathways and tools has been slow and uneven. What senior agency management says publicly about the value and urgency of regulatory innovation has yet to take root in its product review divisions, creating doubt across the broader health care ecosystem that the FDA can be a potent ally in lowering costs and advancing patient access to new and important medical technologies.”