The United States Food and Drug Administration on Tuesday proposed a new rule regarding regulation of medical products that would be the first in the agency’s history to also require the signature of United States Health and Human Services (HHS) Secretary, before it can be formally adopted. 

As such it will likely be a test case for how the new HHS sign-off policy, announced last week by Secretary Alex Azar, may really work in what some observers have described as a politically-motivated power grab by the FDA’s parent organization.

Previously, new rules could be adopted by the FDA with just the signature of the FDA Commissioner, who is currently Stephen Hahn. But last week, Azar issued a memo to all 27 departments under HHS that declared no new rules could be passed within the 27 agencies and offices under the Department without his signature. 

The new proposed rule clarifies the type of evidence considered when determining the “intended use” of a medical product, which would also clarify whether the product falls under the FDA’s regulatory jurisdiction. 

The speed at which this rule is formally approved could signal how the new requirement of the Secretary’s signature will impact the rule-making process at the FDA. 

“The authority to sign and issue any rule for which notice and comment would normally be required, irrespective of whether notice and comment is waived, is reserved for the Secretary. Any prior delegation of rulemaking authority, including the authority to sign or issue a rule or a proposed rule, is rescinded,” Azar wrote in the memo.

HHS has asserted that the new protocol serves merely as a “housekeeping” step.

“The only change made by this memo is that, instead of the Secretary’s just approving all agency regulations, each regulation now also will be formally signed by him. Any speculation about this memo being motivated by policy considerations is utterly misinformed,”  according to a press statement from HHS.

However, the FDA is one of the agencies within the Department that passes the most rules, and in the pandemic, has been the key regulator of COVID-19 diagnostics and treatments. 

And other experts, including former commissioners of the FDA, have called the move “ill-timed” and a “power grab,”  according to the New York Times. 

Indeed Azar’s actions reflect growing political tension between top officials in Trump’s cabinet and scientific and regulatory agencies within the US government. The US Centers for Disease control recently recalled new coronavirus testing guidance that was posted to the CDC website. The faulty guidance was supposedly revised by HHS officials and posted without review by the Center’s top scientists.

And Trump himself last week called FDA Commissioner Stephen Hahn “confused” and “wrong” when Hahn testified in front of Congress that a vaccine would not be available to the general public until late 2021. Trump and his cabinet have been touting that a safe and effective COVID-19 vaccine could be more available by the end of October, a timeline that is also contradicted by blueprints released by the top three firms at the forefront of the COVID-19 vaccine development race.

Tension Between HHS & FDA Escalated With Testing Deregulation

It’s unclear whether requiring the Health Secretary’s signature on new rules will affect the regulatory process for approving a COVID-19 vaccine. However, the FDA has already clashed with Azar over testing regulations in the early days of the pandemic.  

Azar in late August overrode the FDA’s rules for reviewing new COVID-19 tests, despite disagreement from Hahn. According to the HHS rule, “the department… determined that the Food and Drug Administration (“FDA”) will not require premarket review of laboratory developed tests (“LDT”) absent notice-and-comment rulemaking.” 

Instead, the FDA would be limited to “informal issuances,” such as providing non-binding guidance or compliance manuals for new COVID-19 tests.

Some clinical laboratories have long supported this position to bypass the FDA’s potentially lengthy review process, and other supporters have said it could help get new, more innovative tests on the market more quickly. However, critics contended that the FDA already had been granting emergency approval to COVID-19 tests in a timely manner, and Azar’s push of the deregulation created tension within the Department and allows flawed tests to encroach on the market. 

Image Credits: Twitter: FDA Commissioner, University of Washington Northwest Hospital & Medical Center.