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Medtech firms assessing impact of proposed FDA regulation changes

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By Colin Hay - 
Proposed FDA regulation changes medtech firms American Clinical Laboratory Association ACLA laboratory developed tests LDTs

Local medtech companies are rushing to assess proposed new US Food and Drug Administration (FDA) rule changes that seek to have laboratory developed tests (LDTs) regulated as medical devices under the US Federal Food, Drug, and Cosmetic Act.

The proposed changes are being aggressively opposed by numerous associations including the Coalition for 21st Century Medicine (C21) and the American Clinical Laboratory Association (ACLA).

They say the latest FDA announcement is part of an ongoing process that has been evolving for more than a decade and has significant implications for the multi-billion dollar clinical testing industry.

Looking to overcome Congress knock-back

In 2022, the VALID Act, which sought to establish a new framework for the FDA to regulate LDTs, did not pass Congress, and the FDA has now announced that it will seek to use the existing medical device framework to assess LDTs,

The proposed rule would be phased in over a four-year period, after the changes are finalised.

A 60- day comment period is expected to open imminently on the rule changes, however, the FDA has not provided a timeline on when it will make a final decision on the proposed changes.

A coordinated response plan, including legal challenges, will be handled through coalition partners, professional associations and lobby groups that have been preparing for this announcement for several months.

ASX-listed cancer specialist reviewing impact

ASX-listed cancer diagnostics company Pacific Edge (ASX: PEB) said the proposed changes, if finalised, would require it and other LDT providers to present evidence to the FDA that their tests are safe and effective for their intended use in addition to the current regulatory pathway of being accredited through clinical laboratory improvement amendments (CLIA).

“The current system works well for patients and therefore any changes to the regulatory system must maintain that standard outcome. We will continue to work with our partners regarding regulation of our industry that is in the best interests of all stakeholders,” said chief executive officer Dr Peter Meintjes.

“Notwithstanding this position, we have long recognised FDA’s intention to extend its oversight to include LDTs. Consequently, Pacific Edge has been working to prepare the company for this potential regulatory change to minimise any disruption to our US operations, including adopting good clinical practice (GCP) guidelines, and digitalising our clinical development program.”

ACLA speaks out

The American Clinical Laboratory Association (ACLA) has declared that it doesn’t believe the FDA’s actions are in the best interest of patients or the health care system.

The association says it plans to submit comments urging the FDA to withdraw the proposed rule and resume work with Congress, the laboratory community, patient groups, and other stakeholders toward a legislative solution that provides a framework that is appropriate for the unique attributes of LDTs.

“ACLA has long taken the position that FDA does not have statutory authority to regulate LDTs under its medical device authority and strongly opposes unilateral action that exceeds the agency’s current authority. LDTs are not medical devices,” the association declared.

“To the extent that FDA secures legislative authority to regulate LDTs, it must be through a regulatory framework that works with, not against, the LDT regulation already in place through the centres for medicare and medicaid services (CMS) under the clinical laboratory improvement amendments (CLIA).”

The association said any expansion of FDA’s role in this framework should be tailored by congress to fit LDTs, just as has been done for food, supplements, drugs, and cosmetics – each of which has a distinct framework suited to the unique characteristics of its category.

“We also are concerned that FDA is already under resourced and not prepared to complete all of the new work the agency has now proposed to undertake. FDA seriously risks falling behind on its current public health priorities.”

FDA says LDTs intended for clinical use

LDTs are in vitro diagnostic products (IVDs) that the FDA has described as intended for clinical use and designed, manufactured and used within a single clinical laboratory which meets certain laboratory requirements. IVDs are intended for use in the collection, preparation and examination of specimens taken from the human body, such as blood, saliva or tissue.

IVDs, including LDTs, can be used to measure or detect substances, analytes or markers in the body, such as proteins, glucose, cholesterol or DNA, to provide information about a patient’s health, including to diagnose, monitor or determine treatment for diseases and conditions.

The proposed rule seeks to amend the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory.

Along with this amendment, the FDA is proposing a policy under which the agency intends to provide greater oversight of LDTs, through a phaseout of its general enforcement discretion approach to LDTs.

FDA wants to protect patients from delays

The FDA says it is concerned patients could initiate unnecessary treatment, or delay or forego proper treatment altogether, based on inaccurate test results, which could result in harm, including worsening illness or death.

“For example, the FDA is aware of IVDs offered as LDTs that could have led to patients being over-or under-treated for heart disease; patients with cancer being exposed to inappropriate therapies or not getting effective therapies; and incorrect diagnoses of rare diseases, autism, and alzheimer’s disease,” said FDA commissioner Robert Califf.

“A growing number of clinical diagnostic tests are being offered as laboratory developed tests without assurance that they work. The stakes are getting higher as these tests are increasingly being used to drive treatment decisions.”

According to the centres for disease control and prevention, 70% of today’s medical decisions depend on laboratory test results.

“Given the role these tests play in modern medical care, their accuracy and validity have a significant impact on public health.”