Last week, President Trump issued an executive order aimed at encouraging the expansion American manufacturing of essential medical products — Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) (the “Order”).  The Order sets forth an ambitious plan requiring extensive agency action on a tight timeline that suggests a significant impact.  Closer examination of the Order raises significant questions about the practicalities of implementation and the realistic impact of the Order once the substantial stated exceptions are taken into account.

The List

The heart of the Order is a list of Essential Medicines, Medical Countermeasures (“MCMs”), and Critical Inputs to which the Order’s requirements apply — but the key components of this list do not yet exist.  Instead, the Order directs the Food and Drug Administration (“FDA”) to produce the list within 90 days and to include on the list Essential Medicines, MCMs, and Critical Inputs “that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms.”

The Order provides the following definitions that give some insight into what may be on the FDA’s eventual list:
Continue Reading Trump Administration Increases Uncertainty for Pharmaceutical Manufacturing

Last week, the GSA Office of Inspector General (“OIG”) released a Report explaining how GSA decided to abandon previous plans to build a new suburban campus for the FBI, and instead demolish and then rebuild the J. Edgar Hoover (“JEH”) building in Washington, D.C.  Although much of the coverage of the Report has focused on the role of the White House in the decision-making process and the GSA Administrator’s failure to acknowledge that role in testimony before Congress, the Report also highlights the Office of Management and Budget’s (“OMB”) strict approach to the budget scoring rules found in OMB Circular A-11, Appendices A and B.

Continue Reading OIG Report Chronicles Recent Attempts To Construct FBI Headquarters Through Public-Private Partnership, Highlights Proposed Use of Federal Capital Revolving Fund

[This article was originally published in Law360 and has been modified for the blog.]

Earlier this year, President Trump revealed his plan to facilitate new (and much-needed) federal real property projects in part through a $10 billion “mandatory revolving fund,” commonly known as the Federal Capital Financing Fund or the Federal Capital Revolving Fund (the “Revolving Fund” or “FCRF”).  In this article, we take a close look at the Revolving Fund, and discuss the interaction between the Revolving Fund and the Office of Management and Budget (“OMB”) budgetary scoring rules.  As described below, the Revolving Fund is structured to allow federal agencies to meet the large, upfront dollar obligations often required by OMB’s budgetary scoring rules.  But despite this welcome and significant development, questions still remain about the scope and operation of the Revolving Fund.


Continue Reading How Trump Plans To Finance Federal Real Property Projects

On Monday, our colleague Caleb Skeath posted on Inside Privacy an engaging article that discusses the new Office of Management and Budget policy setting forth minimum standards for federal agencies in preparing for and responding to breaches of personally identifiable information (PII) and the expected contractual changes that agencies will impose on contractors whose systems

Earlier this month, the Office of Federal Procurement Policy (OFPP) released a proposed Office of Management and Budget (OMB) Circular, Implementing Category Management for Common Goods and Services, which “institutionalizes” category management as the government-wide model for the acquisition of common goods and services.  Contractors should be aware of this trend, as it could impact both the number of opportunities to secure government contract awards, and the relative size of those opportunities.

If this new initiative sounds familiar, that’s because it is.  In the past, the government has attempted to take advantage of its buying power through centralizing purchasing.  Examples of this include the Brooks Act, which required most agency IT acquisitions to be conducted by GSA, and the mandatory use of the GSA Schedules.  It remains to be seen if OFPP’s new effort will meet with greater success than these past ones.  And it also remains unclear how this new effort will impact the existing GSA Schedules program which, although it is not mandatory, has been the Government’s principal centralized method of procuring commercial items.
Continue Reading What Goes Around Comes Around: OFPP Makes Efforts to Institutionalize Category Management

On December 18, 2014, President Obama signed a bill reforming the Federal Information Security Management Act of 2002 (“FISMA”). The new law updates and modernizes FISMA to provide a leadership role for the Department of Homeland Security, include security incident reporting requirements, and other key changes.

Background:  FISMA was originally passed in 2002 to provide a framework for the development and maintenance of minimum security controls to protect federal information systems. FISMA charged the Director of the Office of Management and Budget (“OMB”) with oversight of agency information security policies and practices.

Changes:  The newly signed law, the “Federal Information Security Modernization Act of 2014” (FISMA 2014”), makes several key changes to FISMA.

First, the law authorizes the Secretary of the Department of Homeland Security (“DHS”) to assist the OMB Director in administering the implementation of agency information and security practices for federal information systems. Among the Secretary’s responsibilities are convening meetings with senior agency officials, coordinating government-wide efforts for information security, consulting with the Director of the National Institute of Standards and Technology (“NIST”), and providing operational and technical assistance to agencies. Perhaps most importantly, the Secretary is tasked with developing and overseeing the implementation of “binding operational directives” to agencies to implement policies, principles, standards, and guidelines developed by the OMB Director. “Binding operational directives” are defined in FISMA 2014 as a “compulsory direction” to an agency “for the purposes of safeguarding Federal information and information systems from a known or reasonably suspected information security threat, vulnerability or risk.”

This delegation of responsibility is likely related to another new law codifying DHS’s cybersecurity role, and authorizing a cybersecurity information-sharing hub, the National Cybersecurity and Communications Integrations Center.
Continue Reading FISMA Updated and Modernized