Drug/diagnostic combinations as a legal defense?
This article was originally published in The Gray Sheet
Executive Summary
Neglecting to use companion diagnostics to improve drug therapy management may open a new market for malpractice lawyers, according to Stephen Little, CEO of Manchester, UK-based genotyping firm DxS Ltd. In London, addressing a recent conference on global diagnostic trends, Little claims "it wouldn't be unreasonable to assume that if an individual is given a drug" without prescribing an available diagnostic to guide patient response, a lawsuit against the physician could follow in the case of adverse events. Conversely, diagnostics that can gauge predispositions to adverse events prior to treatment will help physicians avert malpractice threats, he says...
You may also be interested in...
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.
GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows
A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.