Top News Stories for the Week of March 23

FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits

FDA News Release

Food and Drug Administration (FDA) officials on Friday warned consumers about at-home test kits for COVID-19 that some companies are promoting, noting that the agency "has not authorized any test that is available to purchase for testing yourself at home for COVID-19." In a statement, FDA Commissioner Stephen Hahn and Judith McMeekin, Associate Commissioner for Regulatory Affairs - Office of Regulatory Affairs, noted: "Fraudulent health claims, tests, and products can pose serious health risks. They may keep some patients from seeking care or delay necessary medical treatment." FDA plans to take "appropriate action" to safeguard consumers against "bad actors who take advantage of a crisis to deceive the public by marketing tests that pose risks to patient health. This may include issuing warning letters, seizures or injunctions." Any fraudulent test kits for COVID-19 should be reported to FDA.

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Labs Testing COVID-19 Seek $5 Billion in Emergency Funding

Bloomberg

To fund emergency costs linked to COVID-19 testing, clinical laboratories are requesting $5 billion from Congress. The American Clinical Laboratory Association (ACLA) wrote in a March 18 letter to House and Senate leaders that the Treasury Department should oversee a direct financial fund to cover costs for supplies, equipment, and labor to enable the testing of millions of people nationwide. ACLA President Julie Khani wrote, "We are growing increasingly concerned that the federal government is not recognizing the strain on the laboratory industry to meet the demand for testing for COVID-19. Free testing for COVID-19 has now been promised to the American people. Laboratories should not bear the cost of 'free' testing." She also noted that emergency programs were created in the wake of the financial crisis. The letter said that on Feb. 29, the Food and Drug Administration provided an accelerated path to commercial laboratories. The fund would help support lab personnel, child care, paid sick leave, COVID-19 training, overtime, and cost of uncompensated testing, ACLA said. The letter also pointed out that if the government takes steps to safeguard the nation's economy, such an initiative should cover testing labs by guaranteeing lines of credit and loans along with tax credits to defray bad debt and payroll tax suspensions.

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COVID-19 Testing Delays Shine Light on Lab-Developed Test Regulation Debate

Modern Healthcare

Under the bipartisan VALID (Verifying Accurate, Leading-edge IVCT Development) Act, the Food and Drug Administration (FDA) would have direct authority to regulate tests developed by labs. New mechanisms featured in the proposed bill include technology precertifications, grandfathering, and exemption criteria intended to simplify the regulatory process. The VALID Act also calls for categorizing all diagnostics, including lab-developed tests (LDTs), as in vitro clinical tests and bringing them under FDA's oversight. The bill's emergency use authorization (EUA) provisions are comparable to the policy FDA outlined for LDTs in its Feb. 29 guidance: validate and launch the tests, notify FDA, and later submit the EUA. Gail Javitt, a director at Hyman, Phelps & McNamara, asserts: "That way they don't have to reinvent the wheel every time. The bill's language sets an expectation about how a regulated entity will behave and puts an end to the confusion around whether the FDA will enforce or exercise discretion in an emergency." However, Amy Miller, CEO of the Society for Women's Health Research, warns: "There is a risk that this bill could be politicized. Right now, the clinical labs themselves are focused on developing and distributing coronavirus tests, and making sure tests are done correctly and the results are quickly reported." Many industry observers are worried that the lab industry would face a more burdensome regulatory system and be less agile faced with a health crisis or new scientific development. Others say supply chain issues could be eased by having a centralized authority and greater standardization.

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