On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’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
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
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
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
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
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.
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,
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
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
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
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
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
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
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
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.
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).
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.
The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), both part of the Department of Health and Human Services (HHS), issued final joint guidance on maintaining meeting minutes for Institutional Review Boards (IRBs).
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.
As industry comes up on the one-year anniversary of the publication of Change 2 to the National Industrial Security Program Operating Manual (NISPOM), a number of implementation deadlines are drawing near
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.
While contractors (and their HR departments) dodged a serious bullet with Trump’s recent invalidation of the 2016 FAR blacklisting rule, they need to be alert to a new HR-related compliance requirement as a result of a rule promulgated on the final day of the Obama Administration.
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.
Earlier this week, President Trump put the final nail in the coffin for the former administration’s “blacklisting” rule, officially known as the Fair Pay and Safe Workplaces Final Rule.