A presentation I gave to the Dallas Bar Association, Health Law Section on stem cell regulation in Texas.
The Seventh Circuit determined that professional qui tam relators formed as “investment vehicles for financial speculators” should not be allowed to challenge conduct determined by the government likely to be lawful, and definitely beneficial to the government and the public.
The court creates a new standard for dismissal, joining the standards articulated in Sequoia Orange and Swift. Under the new standard, “[t]he Government may dismiss the action without the relator’s consent if the relator receives notice and opportunity to be heard.”
The FDA proposed updates to clarify the types of evidence it considers when determining the “intended use” of a product. A product’s “intended use” determines whether it is a medical product within the FDA’s jurisdiction. The proposed updates allow any source to be considered, even the subjective knowledge of the manufacturer. The proposed update clarifies, however, that just because a manufacturer has knowledge that health care providers prescribe or use the product for an unapproved use, does not establish a new “intended use” for the product.
Source: FDA Clarifies Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products
The Food and Drug Administration (FDA) will no longer require premarket review of laboratory developed tests (LDTs), including COVID-19 tests, decline to review emergency use authorization (EUA) request for LDTs. Instead, the FDA will prioritize review of EUAs for point-of-care tests, home collection tests, at-home tests, tests that reduce reliance on test supplies, and high-throughput, widely distributed tests.
There is no FDA-approved treatment for COVID-19, but that hasn’t stopped one compounding pharmacy from making bold claims. Marketing products as “COVID PACK” and “COVID ‘POSITIVE’ PACK” for the “treatment and recovery from the Covid-19 virus” apparently crossed the line. These products appear to be nothing more than vitamins. It wasn’t the products that got the FDA’s attention, but rather the claims of treatment, recovery, and cure. The FDA gave the pharmacy 48 hours to correct the misleading claims.
Source: Warning Letter – Pharmacy Plus, Inc. dba Vital Care Compounder