Devices

Attorney Sees Positive Step in Paul’s VITAL Act

Sen. Rand Paul’s Verified Innovative Testing in American Laboratories Act of 2021 (the VITAL Act of 2021) will lead to a better conversation on the regulation of laboratory-developed tests (LDTs) than could come from FDA actions. That’s the opinion of attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) writing in his firm’s FDA Law Blog,

Shapiro has said in the past that any changes to modernize LDT regulation should come from Congress rather than FDA. And Paul’s bill would assign the regulatory responsibility to the Centers for Medicare and Medicaid Services (CMS) rather than FDA. The bill would require CMS to hold a public meeting to solicit recommendations on updating existing Clinical Laboratories Improvement Amendment (CLIA) regulations related to clinical testing laboratories.

“This step would help propel forward a public conversation (which CMS has already started) about how to update these regulations in light of technical advances,” Shapiro writes.

He says that while FDA argues that technological advances in LDTs necessitate that agency’s regulatory oversight, Paul would place the responsibility on CMS through updating CLIA regulations.

“This approach makes more sense,” Shapiro writes, “because the CLIA regulations have always been the main vehicle for regulating clinical laboratory testing. Indeed, the effort these past few years to apply the Federal Food, Drug, and Cosmetic Act (FFDCA) and its implementing regulations to clinical laboratory testing has been a failure. The outcome was not a surprise, because the FFDCA was designed for regulatory oversight of medical device manufacturing and distribution, not clinical laboratory testing. Applying the FFDCA to clinical laboratory testing is akin to putting a square peg in a round hole; it will work for a portion, but there are sharp corners that just do not fit.”

Shapiro concludes that it is time to recognize that an FDA-centric approach is not desirable, although he will explore in the future whether there may be an appropriate, more limited role for the agency.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome