Follow: Email

After more than eight years in the making, the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation (the “Rule”) seems to be a rudderless ship on a shoreless sea. On Monday, the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking delaying the implementation date of the final Rule from July 1, 2018 to July 1, 2019. The final Rule was published eighteen months ago (January 5, 2017) and the implementation date has since been delayed on four different occasions. HRSA has cited a variety of reasons for each delay—compliance with the Regulatory Freeze issued by the incoming Trump Administration; providing stakeholders additional time to prepare for compliance with the Rule; yet more time for compliance preparations; and additional time for HRSA to “fully consider the substantial questions of fact, law, and policy raised by the [R]ule.”

Continue Reading The 340B Ceiling Price and CMP Rule . . . Changes on the Horizon?

Construction contractors take note: the government contractor defense is alive and well in the Fifth Circuit. In Sewell v. Sewerage and Water Board of New Orleans, the Fifth Circuit recently confirmed that construction companies can successfully assert the government contractor defense in response to tort lawsuits that arise from their performance of federal public works and infrastructure projects. This is a welcomed decision in the Fifth Circuit, which had signaled in recent years that a higher level of proof may be required to establish the first element of the defense ─ i.e., that the government meaningfully reviewed and approved reasonably precise specifications for the allegedly defective construction feature.

The Sewell case illustrates that ─ with the right litigation strategy and a skillfully crafted evidentiary record ─ construction contractors may well prove the defense in cases involving even “rudimentary or general construction features.”
Continue Reading Construction Contractors: The Government Contractor Defense is Alive and Well in the Fifth Circuit

A new administration will often articulate its approach to the management of executive agencies through the issuance of an executive order.  President Clinton issued E.O. 12866 in the fall of 1993 and set forth both the process of regulatory review and a regulatory philosophy meant to guide executive agencies.  E.O. 12866 placed an emphasis on cost-benefit analysis and data with which the Office of Information and Regulatory Affairs (“OIRA”) was to review agency action.  President Obama, less than two weeks after taking office, announced his intent to adhere to the “fundamental principles and structures governing contemporary regulatory review set out in Executive Order 12866.”  The reinstatement of E.O. 12866 and eventual issuance of the substantially similar E.O. 13563 foreshadowed the Obama Administration’s focus on data and analysis principles that often resulted in industries submitting an ever-increasing amount of information to executive agencies.

A great deal of attention has been placed on agency regulation by President Trump, who has vowed to cut corporate-focused regulations by “75 percent – maybe more.” Although President Trump has yet to release an official approach to managing the administrative state, the new Administration has taken initial steps that seems aimed at reducing regulations.  Further, Congress has taken up the mantle of deregulation by passing two measures in the House that could severely hamper agencies wishing to issue major rulemaking.  However, without an articulated policy of managing executive agencies, it is unclear whether these measures would actually reduce regulation, or simply shift agency focus from major rulemaking to major guidance, leaving industries without a clear sense of the new playing field.
Continue Reading Reining in Regulation: New Year, New Administration, New Confusion