After a slow start, the FDA is furiously trying to respond to a disease outbreak with every tool at its disposal. But will it be enough?
Alexander Gaffney, RAC is the Senior Director of Research at AgencyIQ. To reach him, please email email@example.com.
Regulators aren’t known for their speed. The pace of federal rulemaking and policymaking is, by design, intended to be slow, methodical and inclusive.
But as the federal bureaucracy pivots—and scrambles—to respond to the outbreak of the novel coronavirus (COVID-19) spreading across the country, the FDA is adopting a very different approach: Fast, nimble, flexible and risk-tolerant.
This is the FDA in emergency response mode, and it’s rapidly building up an armory of policies intended to equip life sciences companies and the public to respond to an ongoing and accelerating crisis in record time.
That armory has begun to take shape in recent days as the FDA’s regulatory apparatus has kicked into high gear. The FDA is producing guidance, regulation and product reviews at a pace that appears to be unprecedented in its history. In the span of a single week, the FDA released nine guidance documents related to COVID-19 and its effects on industry. More seem likely to follow in the days ahead, potentially including guidance on how to repurpose or reprocess used devices like N95 masks to minimize the risks of infection.
But beyond the pace of regulatory publication is the extraordinary scope of new flexibilities offered to industry. In nearly every guidance document, the FDA has offered unprecedented amounts of flexibility to the life sciences sector in the hopes of both accelerating product access while offering up a new vision of what normal might look like.
Consider just a few of the FDA’s actions from this past week.
- Clinical health laboratories will be permitted to develop and use their own tests to detect COVID-19 without first receiving approval from the FDA. This decision comes after 5 years of the FDA expressing its belief that these tests, known as Laboratory Developed Tests (LDTs), were medical devices under its authority and should be regulated as such. Under the new policy, companies would then have 15 days of first use to seek authorization from the FDA to continue marketing the product under an Emergency Use Authorization. In other cases, states could validate the tests instead of the FDA.
- Pharmaceutical compounders will be permitted to compound hand sanitizer despite a federal law prohibiting them from making “essentially copies” of any FDA-approved product.
- Non-traditional entities, including distillers of alcohol, will be permitted to make hand sanitizer. Under that policy, the FDA only asks that companies register their facility and products made using its FDA Drug Registration and Listing System (DRLS) and adhere to basic quality standards.
- Life sciences companies will get extra time and flexibility to report adverse events for all but the most serious events.
- The FDA said companies will be able to make modifications to ventilator products they make without objection.
- Companies will be able to modify their clinical protocols to reflect the potential impact of COVID-19 on their clinical trials.
- Remote monitoring tools can be modified to help address COVID-19 as long as they don’t create an undue risk to patients.
- Companies with drugs subject to Risk Evaluation and Mitigation Strategies (REMS) plans requiring laboratory testing for patients will be allowed to temporarily suspend that testing to ensure patients aren’t needlessly exposed to COVID-19.
Already, the pace of policy change is evident in ways large and small. Last week, the agency announced it would make guidance documents related to COVID-19 available immediately and without public review. Ordinarily, that review process can take months—even years—to complete. And, for the first time in at least a decade, the FDA has begun to publish its guidance documents on weekends.
An extraordinary approach
Under ordinary circumstances, any one of these actions would be extraordinary. Historically, similar extensions of what the FDA calls “enforcement discretion” have been subject to extensive debate by industry and Congress—including the agency’s decision not to treat most mobile medical applications and general wellness devices as medical devices requiring pre-market clearance.
In many cases, the guidance documents don’t just reflect a subtle change in policy, but rather a radical departure—the adoption of an approach that was once considered anathema to the agency. Methodical reviews are now being replaced with a market-first, ask-for-permission-later approach. Erring on the side of patient safety is now being replaced with an approach that instead emphasized product availability. Even clinical trials, the bedrock of evidence used by the FDA to support approvals, may be affected as the FDA considers how to contextualize the effects of COVID.
“What we are seeing in the last week is, for practical purposes, almost an abandonment of FDA regulatory controls in some areas,” one former FDA regulatory official who now works in industry told AgencyIQ.
That change in approach appears to indicate how the FDA is fighting hard to catch up to a virus that threatens to overwhelm the US health care system and its supplies of medical equipment and capacity to test and treat patients.
It may also offer an opportunity for the agency—and its critics—to test how well these approaches work. It seems likely that after the COVID-19 crisis ends, there will be a significant re-evaluation of the FDA’s actions, authorities and methods. Data about the performance of these products is likely to weigh heavily in those discussions.
The pace of FDA action is also likely to be contextualized with the agency’s relatively slow pace of public action in the early days of the COVID-19 public health emergency.
The FDA and other federal agencies had a luxury not afforded to their Chinese counterparts at China’s National Medical Products Administration: Time.
The early days of the outbreak—when the SARS-CoV-2 virus was still largely confined to its place of origin in the Hubei province of China—was when the clock started ticking for US regulators, and when they ought to have started beginning their preparations in earnest.
Even if the spread of COVID-19 couldn’t be stopped, that time could have been used to construct products, policies and preparations from which an effective response could be rallied. More tests could have been approved or cleared. Policies to expand the availability of personal protective equipment and essential devices like respirators could have been enacted. The life sciences industry could have been advised to start planning for the effects of COVID-19 on their businesses and research earlier.
Those policies and actions are only now being put into place, and the FDA—and other government agencies—remain playing catch-up.
Whether the regulator did all it could at the time will be a matter of discussion in the months ahead. It seems likely that a joint commission will be appointed by Congress to consider what went wrong and what blame, if any, to assign to regulatory officials similar to how the 9/11 Commission analyzed failures in the intelligence community.
Upcoming reviews and pressure
In many ways, though, the FDA’s job is only just beginning. Soon, the agency will be tasked with reviewing data, facilitating access to trials and approving new medical treatments. The agency is likely to be under unprecedented pressure from both the White House and the public to bring new products to patients faster than ever.
To do so, it will have a massive number of potential regulatory pathways and expediting methods at its disposal: Emergency use authorization, expanded access, priority review, and accelerated approval, to name but a few. More than likely the FDA will adopt an approach it now uses to review and approve oncology drugs, known as the Real-Time Oncology Review Pilot Program. Under this program, the FDA is able to essentially review applications on a constant, ongoing basis, with some approvals taking place in just weeks instead of the standard review time of 12 months.
The concern for regulators will be whether they can withstand public pressure to approve every medication they receive, especially if that product that is neither safe nor effective under traditional standards for approval.
Instead, the FDA is likely to greatly facilitate access to clinical trials as a means of decreasing pressure and generating the evidence it needs to support future approvals. That could permit continued access to a product even if the FDA is unconvinced of its benefits.
In the meantime, whether the FDA can put effective policies in place to get ahead of the outbreak remains to be seen.
Many lives depend on it being able to do so.
Alexander Gaffney, RAC is the Senior Director of Research at AgencyIQ. To reach him, please email firstname.lastname@example.org