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Category Archives: Government Contracts

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Another step forward in digital health: FDA issues draft guidance for drug master files (DMFs) for electronics and software components of combination products regulated primarily as a drug

On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’ ability to integrate digital health tools which are regulated as medical devices.  The guidance describes when a Type V drug master file (DMF) can be used to

Medical Device Contractor Settles FCA Allegations Based on TAA Violations

On Thursday, August 8, 2019, the Department of Justice (“DoJ”) announced that Danish medical device company Ambu, Inc. (“Ambu”) will pay $3.3 million to settle False Claims Act (“FCA”) allegations that it violated the Trade Agreements Act (“TAA”) (19 U.S.C. § 2518) by selling products to the Defense Logistics Agency (“DLA”) and the Department of

DoD Trusted Capital Marketplace

At a press availability on May 10, Under Secretary of Defense for Acquisition and Sustainment, Ellen Lord, discussed the “matchmaking” service the Department of Defense (“DoD” or “Department”) is helping to create, to put small and struggling firms together with trusted sources of capital.  This program may be viewed as a positive step that is

Likely FDA Impact of the Government Shutdown: Regulatory Submission Reviews, Inspections, and Research Projects

The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019.  Unfortunately, FDA is one of the agencies with at least some functions shut down, as was announced yesterday.  Among other things, FDA has furloughed 42% of its employees, according

Small Business Runway Extension Act of 2018 Becomes Law: Increases Revenue Look-back Period to Five Years for Small Business Size Eligibility Determinations

On December 17, 2018, the Small Business Runway Extension Act of 2018 (“Act”) (H.R. 6330) was passed by President Trump into law. The new law amends the Small Business Act at 15 USC 632 to require that the size of a federal contractor for purposes of determining small business eligibility be measured based on the

China Takes Significant Steps to Consolidate Generic Drug Industry and Lower Prices

With the opportunity for global pharmaceutical companies to gain new access to the Chinese market presenting itself like never before (see our previous blog posts here and here), significant news broke on December 7, 2018, regarding a newly implemented pilot centralized drug procurement program (the “program”) that will have significant ramifications for global pharmaceutical companies. 

FDA and DoD strengthen collaboration for medical products with military applications that could also be expanded to the general population

On November 2, FDA and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding (MoU) that formally establishes the framework under which the DoD and FDA will implement  Public Law 115-92, which was enacted in 2017.  The law gives the DoD new opportunities to advocate to FDA for expedited development,

CMS proposes requiring drug prices in TV ads

On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or Medicaid to include the Wholesale Acquisition Cost (WAC).  This proposed rule resembles a rejected Senate amendment to the FY-2019 Labor-HHS-Education appropriations bill (analyzed here) that would

VA and SBA Release Complementary Final Rules Updating their Veteran-Owned Small Business Regulations

On September 24, 2018 and September 28, 2018, the Department of Veterans Affairs (VA) and the Small Business Administration (SBA), respectively, released complementary final rules (VA final rule and SBA final rule) that amend the regulations governing Veteran-Owned Small Businesses (VOSBs) and Service-Disabled Veteran-Owned Small Businesses (SDVOSBs). Effective October 1, 2018, the SBA’s regulations now

For Now, DoD Halts Efforts to Change Policy on Progress Payments

Deputy Secretary of Defense Patrick Shanahan announced on Monday, October 1, 2018, that the U.S. Department of Defense (“Department” or “DoD”) was withdrawing its proposal that would have made sweeping changes to the rules that govern the release of progress payments to contractors under DoD contracts. In rescinding the proposed rule, Deputy Secretary Shanahan cited

The Trump Administration Issues Its R&D Budget Priorities for FY 2020

On July 31, the Director of the Office of Management and Budget, Mick Mulvaney, and the Deputy Assistant to the President, Office of Science and Technology Policy, Michael Kratsios, jointly issued a memorandum on “FY 2020 Administration Research and Development Budget Priorities.” This is an annual document, providing overall policy guidance to the federal agencies

SBA Update: Less Than 1% Minority Shareholder Interest Could Impact Eligibility for Small Business Contract Awards

The U.S. Small Business Administration (SBA) Office of Hearings & Appeals (OHA) recently held that an entity may be affiliated with another entity solely because it holds a very small minority ownership interest (less than 1%) in that entity. OHA’s ruling is noteworthy because under the SBA’s rules, the employees or revenue (depending on the

Legislative and Regulatory Update on Federal Supply Chain Risk Management

The U.S. Government is renewing its focus on mitigating technological risks by regulating the supply chain for various goods and services. To achieve these goals, Congress and agencies have introduced, and in some cases enacted, legislation and regulations that direct agencies to identify, assess, and mitigate supply chain risks generally as well as prohibit agencies

Have you checked your bank account information on SAM recently?

The General Services Administration (“GSA”) recently announced that it is investigating fraudulent activity on the government contractor registration site SAM.gov. If you are a government contractor and do not already know about this development, then chances are your company was not one of a “limited number” of registered entities that GSA has identified as victims

Indictment in $40M Alleged Fraud Case Signals Increased Scrutiny of SDVOSB Government Contractors

On December 1, 2017, the U.S. Department of Justice announced the federal grand indictment of an army veteran for allegedly engaging in major government program fraud by using his status as a service-disabled veteran to obtain contracts set-aside for service-disabled veteran-owned small businesses (SDVOSBs), despite the fact that he did not control the management and daily operations of the company to which the contracts were awarded.

Change comes to the Defense Security Service: The Transition from e-FCL and ISFD to NISS on October 30, 2017

On October 30, 2017, the U.S. Department of Defense (DoD) Defense Security Service (DSS) will complete its transition to the National Industrial Security System (NISS). The NISS will replace two predecessor systems: the Industrial Security Facilities Database (ISFD), and the Electronic Facility Clearance System (e-FCL).

McDowell v. CGI Federal Inc.: A Stark Reminder to Government Contractors of their Cybersecurity Obligations

On June 1, 2017, the United States District Court for the District of Columbia issued a decision in a class action lawsuit, McDowell v. CGI Federal Inc., Civ. Action No. 15-1157 (GK) (D.D.C. 2017), which could have significant repercussions for government contractors operating information systems that house government information.

DOJ announces one of largest False Claims Act recoveries concerning U.S. Government small business programs

Last week, the Department of Justice (DOJ) announced a $16 million settlement with Virginia-based government defense contractor, ADS Inc., to resolve allegations that ADS and its subsidiaries violated the False Claims Act by submitting claims for payment under fraudulently obtained small business set-aside contracts.

“Double Dip” Effectively Approved by Center for Medicare and Medicaid Services

Last week the Centers for Medicare and Medicaid Services (CMS) issued Release No. 104 to Manufacturers and Release No. 180, which invalidated earlier agency releases addressing the treatment under the Medicaid drug rebate program of Federal Supply Schedule (FSS) purchases by Indian Health Service (IHS) facilities.

New E.O. Reinforces President Trump’s “Buy American” Agenda

On April 18, 2017, President Donald Trump signed the executive order “Buy American and Hire American” aimed at maximizing the federal government’s use of goods, products, and materials produced in the United States. The E.O. does not attempt to change existing law, but requires agencies to increase monitoring, enforcement, and compliance with Buy American Laws while minimizing the use of waivers.