In the last couple weeks, I ran across a number of interesting articles from law firms about the FDA proposal to regulate lab developed tests - LDTs.
FDA LDT & LAW [Amin/Morrison & Foerster]
The first one, I did highlight in a blog back on November 10. This is an essay by stacy Amin, a former FDA attorney, now at Morrison & Foerster. Her essay focuses on potential legal weaknesses of the FDA's proposal to regulate LDTs, and how the FDA has attempted to preempt them with various parts of its justification.
FDA SWOOPS INTO MCED [Mullen, Gibbs/Hyman Phelps Mcnamara]
This fits the "FDA LDT" topic because Mullen and Gibbs give a no-holds-barred account of the surprisingly sudden appearance of an FDA workshop on the MCED topic. They suspect tie-ins to the FDA's LDT agenda as a whole. They note several oddities about the workshop. Good essay. "FDA Stealthily Convenes Multi-Cancer Testing Panel Meeting."
The Mullen/MCED essay includes three track-backs to prior essays about aspects the LDT rule.
- The first simply introduces the FDA's land grab, by Cato, Mullen, Javitt on September 29.
- The second is a livelier style and opens with the headline, "Raises Many Questions, Provides Few Answers." By Mullen, Javitt, Won on October 6.
- The third tracks to the same topic as Stacy Amin's essay, the legal weaknesses of the FDA's position. "Would a Final Rule Withstand Judicial Scrutiny?" By Mullen, Javitt, et al, on November 2.