Not So Fast: Trump Team Paints US FDA Review Times As Too Slow
Executive Summary
New ‘statement of policy’ directs US FDA to publish charts of its approval timeliness – using an outdated 180-day benchmark to make its approval speed look worse.
The final days of the Trump Administration have been marked by repeated conflict between the US Department of Health & Human Services and the Food & Drug Administration over the limits of the agency’s authority.
That turf war has played out via formal notices – like an effort to force FDA into a laborious process to justify long-standing regulations. (Also see "Some Long-Standing FDA Regs Face Mandatory Review Or Rescission Under New HHS Rule" - Pink Sheet, 8 Jan, 2021.)
And it has played out in staffing, with competing announcements of an acting Chief Counsel following the resignation of Stacy Cline Amin leaving Mark Raza able to note that he served in the post for several hours if he ever chooses to include it on his resume. (Also see "FDA Chief Counsel Stacy Cline Amin Guided Agency Through COVID-19 EUAs And Guidances" - Pink Sheet, 11 Jan, 2021.)
There are substantive issues at play, for sure, including long-standing questions about the scope of FDA’s authority over items like lab-developed tests, and the right boundaries to draw on medical devices that can be ushered through on the abbreviated 510(k) pathway versus those that require more intense pre-market review.
But there is also an astounding degree of pettiness. Take HHS’ latest salvo: a “statement of policy” on “FDA Drug Review Timeline Transparency,” which directs FDA to publish annual reports on review times for each NDA and ANDA approval – and to call out the amount of time each review took in excess of 180 days.
Why not take credit for hyper-fast reviews rather than push a contrary narrative in the closing days of the Administration?
Why 180 days? Well, technically, that is the statutory deadline for FDA to act on NDAs, and has been since the 1962 efficacy amendments. “At the time,” HHS helpfully points out, “the 180-day timeline for review of ‘new drugs’ was uncontroversial.”
True, but then again, NDAs before 1962 could fit comfortably in a manilla envelope. And, whatever the reason, the 180-day deadline has never been met consistently by the agency and long has been supplanted by negotiated review timelines under the user fee program that began in 1992.
Nevertheless, the Federal Register notice, scheduled to be published on 15 January, implies that FDA should or could be doing more to meet a timeframe that was once upon a time “prescribed by Congress.”
The notice acknowledges FDA’s increased efficiency under PDUFA – but suggests that somehow the agency should still be benchmarked against the 1962 timeline. The notice even suggests that other analyses (like those conducted by the Government Accountability Office) are flawed for failing to note to the underlying statutory deadline.
“Though the agency has made strides over the years to expedite review in the face of limited resources, the total time elapsed between FDA’s filing of an NDA or receipt of an ANDA to ultimate approval or disapproval of the application often exceeds 180 days,” the notice says.
“Even so, reporting on drug approvals, such as GAO’s March 2020 report, focused primarily on agency compliance with PDUFA dates. The GAO report did not mention the 180-day benchmark or discuss the agency’s approval timeframe in view of that requirement.”
In the spirit of helping FDA with its new reporting obligation (one assumes), HHS includes data on the 48 NMEs that were approved by FDA in 2019, 38 of which were approved more than 180 days after submission of an application.
HHS generously acknowledges that these tardy reviews may not be entirely FDA’s fault: “It should be noted that in many instances the failure to meet the 180-day statutory benchmark may have been justified and in such cases, was frequently the result of questions by the agency and responses by the applicant.”
Talk about flipping the story on its head. It isn’t the 38 “late” reviews that are notable, it is the 10 exceptions.
In 2019, ten of the 48 NMEs were approved at least two months early – meaning that they cleared FDA on or before the review deadlines that used to govern NME filings before the inclusion of a new, two-month “filing review” period in 2012. This is similar to actions in 2018 but a departure from historical practice – in the mid-90s, for example, only HIV drugs saw hyper-fast approvals.
Why not take credit for that, rather than push a contrary narrative in the closing days of the Administration?
HHS notes that members of the public can use the information to further study health and economic impacts, and that the information can “inform Congress as to whether to provide FDA with additional resources to carry out the agency’s review obligations within the timeframe prescribed by Congress.”
They could, yes. Of course, FDA could also decide to meet the 180-day deadline and reject essentially every NDA where there are any issues that might need a minute to resolve. Or Congress could formally repeal the 180-day deadline in the name of statutory consistency.
In the meantime, FDA is directed to publish new charts showing the tardiness of NDAs and ANDAs. This is necessary, HHS writes, because drug approvals affect “the health and financial well-being of all Americans,” thus the public is entitled to such information.
Information that is not terribly useful, is technically already available (with public approval letters and a little math), and which is unlikely to be a priority in the Biden Administration when it takes over in one week.