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CMS and OIG Propose Changes to the Stark Law, Anti-Kickback Statute and Civil Monetary Penalty Rule
…to value-based care and improve the coordination of patient care among providers and across care settings in the both the Federal health care programs and commercial sector.” A. Safe Harbors…
How Far Does FDA’s Say-So Travel?
…and unusual statement by U.S. Supreme Court Justice Antonin Scalia (joined by Justice Clarence Thomas) invites the right party, in the right civil case, to challenge a federal agency’s interpretation…
HRSA: No Further Delay of 340B Ceiling Price and Civil Monetary Penalties Rule
…its 340B program ceiling price and civil monetary penalties regulation from July 1 to January 1, 2019. After reviewing comments on the proposal, many of which were critical of the…
District Court Enters Consent Decree Against QVC for Third Party Representations; QVC to Pay $1.5M in a Civil Monetary Penalty and $6M in Consumer Redress
…order by making false or unsubstantiated claims for several weight-loss products. The 2009 Consent Decree slaps QVC with a civil monetary penalty of $1.5 million and consumer redress of $6.0…
Drug Pricing Reform Gathers Steam (Part 2)
…group and individual health plans in the commercial market. Beginning in 2025, payment for certain “Selected” single source drugs under Parts B and D, and under commercial plans that do…
When Does the Expiration of Pediatric Exclusivity Allow ANDA (or 505(b)(2) NDA) Approval? The Case of Generic BENICAR
…had the potential to raise an interesting dispute over the so-called “failure-to-market” 180-day exclusivity forfeiture provision at FDC Act § 505(j)(5)(D)(i)(I) based on Mylan’s Paragraph IV certification to U.S. Patent…
First Anniversary of the Consumer Product Safety Improvement Act of 2008
…plant-derived and animal-derived materials. The draft final rule also identified certain metals and alloys that do not exceed the lead content limits. The preamble to the draft final discussed certain…
Under FDORA, FDA to Require Most Drug and Device Trials to Submit Diversity Action Plans
Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they…
FDA Releases Food Safety Plan Software
…in developing a food safety plan. Even larger manufacturers who have already developed their plans may be tempted to delve into the FSPB as a point of reference. In conjunction…
Biosimilar Action Plan Introduced to Kick-Start the Biosimilar Market
…and delaying biosimilar entry until potential manufacturers withdraw from an unprofitable market, and FDA is trying to strengthen its defense. To this end, Dr. Gottlieb emphasized the use of carve…
Compounding Remains an FDA Priority: Agency Announces 2018 “Compounding Priorities Plan” and Several Compounding Guidances, Including Guidance on “Essentially Copies” and Repackaging
Last week FDA announced the release of its 2018 “Compounding Priorities Plan.” FDA also released several guidance documents in the wake of its announcement, such as its final guidance on…
FDA’s Hatch-Waxman Public Meeting and Progression of the Agency’s Drug Competition Action Plan
…of the original (called “product hopping,” incremental innovation, or the seemingly repurposed term “evergreening”); the potential to misuse the citizen petition process to delay generic drug approval; and pay-for-delay arrangements….
Better Late Than Never – Unpacking FDA’s Highly Anticipated (and Long Overdue) Draft Guidance on Diversity Action Plans
…of other population-level or individual characteristics that may impact clinical outcomes (e.g., socio-economic status, geographic location, comorbidities). Data on relevant factors for device performance (e.g., phenotypic, anatomical, technological, or biological…
Legal Setbacks and Legislative Inaction May Push the FTC to Consider “Plan C” to Address Patent Settlement Agreements
…. .” As we previously reported, this case stems from a February 2009 challenge by the FTC and the California Attorney General concerning Solvay’s ANDROGEL in which the FTC alleged…
FDA Guidance Outlines a Framework for the Evaluation of Long-Term Neurodevelopmental Safety Studies in Neonatal Product Development
…pronouncements elsewhere on this topic, the Guidance describes FDA’s limited experience with alternative assays to characterize neurodevelopmental toxicity while expressing a theoretical openness to such methods when feasible. Additional product-specific…