HP&M Asks FDA Not to Narrowly Constrict the Formal Dispute Resolution Process

By Josephine M. Torrente & Etan J. Yeshua –

In September, FDA proposed a significant limitation on the way drug sponsors can appeal FDA decisions, and yesterday Hyman, Phelps & McNamara, P.C. (HP&M) formally requested that the Agency reverse course. In a draft guidance document issued in September, FDA stated that advice from review divisions to drug sponsors as formalized in meeting minutes and in advice letters would no longer be appealable to officials above the review division. Until now, the Agency routinely accepted requests for such appeals through its “formal dispute resolution” (FDR) procedures.

Requests for formal dispute resolution – which involve critical drug development issues ranging from Phase 3 study endpoint selection, to the need for carcinogenicity studies, to the adequacy of impurity characterization – make it possible for a sponsor to ensure that advice it receives from a review division (particularly advice with which the sponsor disagrees) has been vetted and approved by senior officials at the Agency. But FDA’s proposed new practice (as demonstrated by one example in the comment we submitted yesterday) would require that a review division repeat the same advice no fewer than five times over multiple years before that advice would be appealable. This is an untenable position for the Agency to take.

As we stated in our comment to the draft guidance document:

[O]ur firm has drafted dozens of FDR requests for clients and has also advised numerous other clients that pursuing FDR was not advisable based on the facts or circumstances of their cases . . . [A] failure to resolve such disputes efficiently and effectively has the palpable potential to hinder the availability of promising drugs and biologics and, ultimately, public access to them – sometimes for many years and sometimes forever.

Just last week, the Agency stated in a separate draft guidance document that, “It is critical to efficient drug development for sponsors to ascertain FDA’s views on the applicable statutory and evidentiary requirements well in advance of submission of an application.” We couldn’t agree more: timely use of the dispute resolution process can give a sponsor confidence that a review division’s advice is “FDA’s view” and is not merely an initial determination liable to be overturned later in the development process.

However, unless the Agency reverses its new position on the reviewability of a division’s advice, a sponsor who questions or disagrees with the scientific or regulatory feedback it receives from a review division would be faced with two risky and untenable options: either stake its development plan on the division’s controversial advice, or reject the division’s advice and pursue the path that the sponsor believes is scientifically and legally warranted. In either case, the sponsor would be taking on significant and preventable risk. Rather than allowing scientific and regulatory disputes to be appealed in a timely manner, the new FDA practice would require the sponsor to wait until FDA rejects or refuses to file the IND, NDA, or BLA in order to determine that the division’s advice had been vetted and approved by more senior officials at the Agency. By then, much may have been wasted: large numbers of patients participated in unnecessary placebo-controlled trials; years of patent life on the product were lost; and millions of dollars were spent on trials that could have been avoided had the dispute resolution process been available earlier.

To prevent wasted efforts by patients, investigators, sponsors, and the Agency itself, HP&M’s comment, which you can read here, requests that FDA revise its guidance document and continue its long-standing practice of accepting requests for formal dispute resolution when the dispute arises. We hope the Agency will do so.