Source : Medtech Insight
The Pew Charitable Trusts urged the Biden administration to rescind a number of policies enacted under the Trump administration including those that apply to laboratory developed tests (LDT) that it says put the public at risk.
Pew, a nonpartisan Washington-based policy think tank, wrote to the US Department of Health and Human Services on 28 April, urging it to reverse a number of policies that it says hurt the US Food and Drug Administration’s ability to regulate diagnostic products and protect the public. The letter comes after the Biden administration put a temporary freeze on so-called “midnight regulations” that the Trump administration pushed out the door just before leaving office, many of which were intended to deregulate oversight of public health. ()
One of the main issues that Pew raises is former HHS secretary Alex Azar’s August 2020 decision to not regulate LDTs that are sometimes used to diagnose COVID-19. The issue of LDT regulation has been ongoing since the Obama administration proposed allowing the FDA to use a risk-based approach to regulate the tests, which had been typically overseen through the Clinical Laboratory Improvement Amendments. When the Trump administration came to power, however, the agency backed off that plan and former FDA commissioner Scott Gottlieb decided the issue needed to be dealt through congressional legislation rather than FDA regulations. ()
“The question of FDA’s jurisdiction over LDTs has been debated for many years, and was only complicated by the HHS announcement last year,” Pew said in the letter, which was signed by Liz Richardson, the organization’s health care products project director. “While it is important to immediately reinstate FDA’s ability to review COVID-19 LDTs prior to their use on patients, the administration should also prioritize reforming the entire diagnostic testing regulatory regime under the oversight of FDA.”
The think tank said Azar’s decision to not regulate LDTs not only eliminated a critical quality check on LDT COVID-19 tests but also stripped the FDA of its ability to require premarket review for any LDTs.
“This decision is extremely shortsighted given that the FDA recently evaluated 125 Emergency Use Authorization applications from labs—the main producers of LDTs—and found that among them, 82 had design or validation problems that needed to be addressed before they could be offered to patients,” said Pew. “Now, LDTs for the novel coronavirus are not required to be subject to even these baseline FDA quality checks and could make it to market unabated.”
The think tank said that the decision put patients at risk. While the FDA can undertake a formal rule-making process to correct the decision, it could take years to implement.
In a subsequent statement, former FDA commissioner Stephen Hahn pushed back against the HHS policy and stated the agency could still regulate LDTs under its authority in the Public Health Services Act. Pew, however, says that doesn’t provide sufficient legal certainty and argued there still needs to be legislation that specifically states the agency has the authority to regulate LDTs.
Pew also argues the current CLIA-based oversight of LDTs “distorts the diagnostics market” and creates and uneven playing field for LDT versus non-LDT products. The think tank also said the current system disincentives LDT developers from doing more research into the accuracy of their tests.
“The current crisis has further highlighted the urgent need for a uniform, commonly understood regulatory framework for all in vitro clinical tests and one that appropriately balances the need for rapid innovation with the need to ensure test quality,” said Pew. “Rather than forgoing FDA review of all tests developed and used within the same laboratory—the approach adopted by HHS in August—the administration should establish a universal framework for all tests that would help to avoid such challenges in the future and improve regulatory oversight of these important public health tools
Besides the policy on LDTs, the Trump administration’s HHS also published two notices right before leaving office to not regulate certain class I and class II products. Biden’s HHS and FDA, however, recently stopped them from taking effect, releasing scathing notices from acting FDA commissioner Janet Woodcock stating that the previous decisions were made without any input from her agency and were illegal. ()
Furthermore, the Biden administration has also delayed implementing the Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) Rule that would require HHS agencies, including the FDA and the Centers for Medicare and Medicaid Services, to review most regulations every ten years. Rules that are not reviewed on time would be automatically rescinded. ()
“We appreciate the administration’s temporary regulatory freeze announced on 20 January and commend the recent joint decision from the Department of Health and Human Services (HHS) and the FDA to withdraw a previous proposal exempting 84 devices from premarket review which would have posed a major threat to public health if enacted,” Pew said. “Further, we applaud the HHS decision to postpone the implementation of the Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule. If implemented, the SUNSET rule would have been an incredibly burdensome project for any federal agency to undertake, and we appreciate that HHS recognized this and took steps to address the issue.”
Pew also recommended rescinding a final rule that would require job reviews of FDA center directors every five years that could have political consequences. ()
“Placing career civil servants under formal review on a regular basis to determine whether they should be retained or reassigned could have a range of negative consequences, both for the FDA and for public health,” the think tank said. “Most concerningly, it could make senior staff more susceptible to political pressures, particularly if they know their position may be threatened by taking a politically unpopular stance. One of the key lessons of the pandemic is the need for strong public health agencies that are driven by science—this policy could further undermine confidence in the FDA’s independence from politics as well as confidence in the safety or effectiveness of products reviewed by the agency.”
By Ferdous Al-Faruque