David Yang
As the recent Bright Lights USA case demonstrates, export violations continue to be met by aggressive enforcement actions by U.S. government authorities. In Bright Lights USA, the U.S. State Department’s Directorate of Defense Trade Controls (“DDTC”) charged and fined a small manufacturer $400,000 for violating the International Traffic in Arms Regulations (“ITAR”) by exporting, without obtaining a license, engineering designs and drawings abroad for minor vehicle spare parts (such as rubber seals, gaskets and grommets, etc.) in connection with bids sent to foreign manufacturers to produce the parts for Bright Lights to resell to its commercial and public sector customers. Although the parts were commercial items and many other similar parts in the category in which Bright’s Lights conducted business had transitioned off of the U.S. Munitions List, the company had failed to update its list for parts that were still controlled. The DDTC found that the violations had occurred in large part due to the company’s “significant training and compliance program deficiencies.” Continue reading “Risk Management in the Export Controls Minefield (Part 2 in a Series)”
Hurricane Harvey’s damage to Texas and other areas is virtually unprecedented and is already estimated to be in the tens of billions of dollars. And Hurricane Irma, hurtling towards Florida, could likewise cause catastrophic damage. Though every disaster presents unique recovery challenges, a common theme in disaster relief efforts is the key role of the Federal Emergency Management Administration (“FEMA”) and a federal law known as the Stafford Act. Contractors eager to assist with relief and rebuilding efforts should pay close attention to the legal landscape underpinning the public funding behind disaster relief efforts, particularly given the scrutiny these efforts will receive in the wake of Hurricane Katrina. 
A recent federal court decision vacating a staggering 15-year debarment based on shortcomings in the administrative record offers a glimmer of hope to contractors facing exclusion from federal programs, and reinforces the importance that any final debarment decision be based on a fulsome record—particularly in “fact-based” debarments where there are disputed material facts. The big takeaway for contractors facing an exclusion is to ensure that the administrative record on which a debarment decision is based reflects all information showing why an exclusion is unwarranted (or unnecessary) to protect the Government.
For years, states and the federal government focused their drug pricing enforcement efforts on higher priced and more expensive branded drugs. Not surprisingly, private qui tam lawyers followed on the coattails of these government enforcement efforts. The focus on branded drugs was not wrongheaded. States, the federal government, and qui tam plaintiffs were handsomely rewarded for such efforts, as in the multiple Average Wholesale Price (“AWP”) cases against brand manufacturers. However, while regulators focused on brands, they subsequently found that the pricing for generic drugs had increased unimpeded. In more recent years, the focus has shifted to generic drug price increases. For example, effective for the first time at the start of 2017, the Medicaid Program applied an inflation penalty component to Medicaid rebate payments for generic drugs. Historically, the inflation penalty applied only to branded drugs. The inflation penalty provides that when a drug’s price increases faster than the increases in the Consumer Price Index for All Urban Consumers, a manufacturer is required to pay an additional Medicaid rebate amount to state Medicaid programs. 
It is no secret that deregulation is a top priority for the Trump Administration and the Republican-led Congress. In the early weeks of governing together, President Trump and House Speaker Paul Ryan have dusted off the Congressional Review Act (“CRA”) as the tool of choice for undoing federal rules and regulatory initiatives implemented by the Obama Administration. The little-known but important law, enacted by President Clinton in 1996, provides Congress with the ability to enact legislation overturning certain federal agency rules. In the more than two decades on the books, the CRA has only been used to overturn a federal rule on one occasion when, in 2001, President George W. Bush signed a resolution overturning an ergonomics rule issued by the preceding administration. However, despite its past obscurity, the CRA is now more important than ever. 
Despite recent political shifts away from globalization, international trade remains a bedrock of the U.S. economy, and companies doing business in the United States must be cognizant of the intricate set of export control regulations promulgated by the U.S. government. In today’s rapidly changing economy, it is more important than ever for companies to thoroughly assess their connections to the international marketplace. While the Obama Administration took strides toward simplifying the export control process, U.S. export control regulations remain complex due to the multiple government stakeholders involved, resulting in varying interpretations, policies, and agendas. Export control violations can still carry serious ramifications for a company’s business practices both inside and outside the United States. Accordingly, the first of this three part series begins by identifying whether your business may be subject to the U.S. export controls regime. Our next two installments will then, respectively, address: (Part 2) practical strategies for addressing risk mitigation; and (Part 3) enforcement actions by the government. 
The Department of Homeland Security (“DHS”) recently issued three new proposed cybersecurity regulations for DHS contractors which warrant careful attention. Although a freeze on new regulations by the Trump administration will likely delay any final agency action, and extensive comments and meaningful changes to any final rules are expected, these new regulations could radically impact the compliance landscape for DHS contractors. As with recent cybersecurity amendments to the Federal Acquisition Regulation (“FAR”) and Defense Federal Acquisition Regulation Supplement (“DFARS”) (which we’ve covered