As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and regulations across pharmaceuticals, biologics, medical devices, diagnostics, and laboratory testing, our Life Sciences Regulatory & Compliance team has provided
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FDA Targets April 2024 for Laboratory Developed Test (LDT) Final Rule
On December 6, 2023, the Office of Information and Regulatory Affairs (“OIRA”) released the Fall 2023 Unified Agenda of Regulatory and Deregulatory Actions (the “Agenda”), a semiannual compilation of information regarding regulations under development by federal agencies. In its preamble, the Department of Health and Human Services (“HHS”) notes that the regulatory actions forecasted
A Practical Look at OIG’s New Compliance Guidance
On November 6, 2023, for the first time in 15 years, HHS OIG issued a new reference guide for the health care compliance community – the General Compliance Program Guidance, or GCPG. While the GCPG does not set new legal standards and largely reinforces existing guidance, it is a tremendous tool to help health
Significant 340B Drug Pricing Program Litigation May Impact 340B Scope
Two recent federal court cases signal new significant developments with respect to the 340B Drug Pricing Program. Specifically: (1) new federal district court litigation challenging a recent HRSA Notice involving 340B Program “child site” registration and eligibility; and (2) a court decision in other litigation that implicates the scope of the 340B “eligible patient” definition.
2023 State Drug Transparency Law Development Update
In October 2021, we reported on an uptick in the passage of state drug price transparency legislation. As an update to that report, as of October 2023, approximately 22 states have now passed drug price transparency laws creating new requirements for drug manufacturers.
Each state has its own unique set of requirements, but reporting is
United States: Trends of Agency Scrutiny on Pharmaceutical Transactions Expected to Shift Amid Rise in Deal Activity (GCR)
Despite the threatening rhetoric, the early years of the Biden Administration largely followed previous regimes with respect to antitrust enforcement in the life sciences space. Pharmaceutical transactions in particular encounters the expected amount of agency scrutiny, with most proceeding without an extended investigation and, in contrast to deals in the tech space, did not become
Newly Launched: Goodwin’s Laboratory Developed Tests Resource Page
Our Life Sciences Regulatory & Compliance team has launched a new resource page, keeping you up-to-date on the latest regulatory developments affecting laboratory developed tests (LDTs). Our dedicated LDT page provides foundational materials, legislative and regulatory history, and updates and analyses regarding initiatives to increase oversight over LDTs, including FDA’s LDT Proposed Rule (October 2020).
Antitrust & Competition Life Sciences Quarterly Update Q3 2023
The third quarter in the life sciences space saw notable developments in significant agency enforcement actions:
- The FTC abandoned its pursuit of a novel theory and settled its Amgen/Horizon lawsuit 10 days before the scheduled preliminary injunction hearing. As detailed below, the settlement is fairly modest in scope and embraces the sort of behavioral remedy
How to Get Your SIUU Out: FDA Provides Long-Awaited Update for Industry on Communicating Off-Label Information
On October 23, 2023, FDA announced the availability of a revised draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products.” The draft guidance supersedes the agency’s 2014 draft guidance, “Distributing Scientific and Medical Publications on Unapproved New Uses,” and it provides more direction for
Some Much-Needed (Applicant-Friendly) Clarification on Priority Claims at the European Patent Office
On October 10, 2023, the Enlarged Board of Appeal of the European Patent Office (EPO) issued a consolidated decision in cases G1/22 and G2/22 clarifying a common issue regarding the validity of a priority claim made at the EPO. Per the Board of Appeal, there is a rebuttable presumption that an Applicant claiming priority is entitled