Jennifer Plitsch

Jennifer Plitsch

Jennifer Plitsch is co-chair of the firm’s Government Contracts practice group. Her practice includes a wide range of contracting issues for large and small businesses in both defense and civilian contracting. Her practice involves advising clients on contract proposal, performance, and compliance questions as well as transactional and legislative issues. Her practice also includes bid protest and contract claims and appeals litigation before GAO, agency boards and the federal courts. Ms. Plitsch has particular expertise in advising clients in the pharmaceutical and biologics industry. She advises a range of pharmaceutical and biologics manufacturers on Federal Supply Schedule contracts, including the complex pricing requirements imposed on products under the Veterans Health Care Act, as well as research and development contracts and grants with various federal agencies. She also has significant experience advising on the requirements of various programs under which vaccine products and biodefense medical countermeasures are procured by the Government.

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DoD Seeks Streamlined Procurements of Innovative Technologies – Other Transaction Agreements and the Commercial Solutions Opening Pilot Program

The Department of Defense (DoD) has once again emphasized its willingness to engage with commercial companies and other non-traditional contractors to try to expedite and simplify its procurement of innovative technologies. In particular, the Defense Information Systems Agency (DISA) indicated that it plans to enter directly into Other Transaction Authority (OTA) agreements, and DoD issued a … Continue Reading

Bipartisan Legislation Aims To Strengthen “Buy American” Requirement Under National School Lunch Program

[A modified version of this blog post was published in Law360.] Last month, Senators Dan Sullivan (R-AK) and Maria Cantwell (D-WA) introduced legislation to “improve the requirement to purchase domestic commodities or products” under the National School Lunch Program (the “NSLP”) and the School Breakfast Program (the “SPB”).  Even if this legislation fails to make … Continue Reading

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

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 … Continue Reading

Fourth Circuit Further Defines Scope of Contractor Risks in the FMS Sales Context

The Court of Appeals for the Fourth Circuit recently published a decision that expanded on its prior Trimble ruling that a foreign government customer cannot sue a U.S. contractor in the Foreign Military Sales (“FMS”) context (at least in U.S. courts).  In BAE Sys. Tech. Solution & Servs., Inc. v. Republic of Korea’s Def. Acq. … Continue Reading

If Shulkin Didn’t Resign, Who Runs the VA Until a New Secretary Is Confirmed? A Vacancies Act Puzzle

Recent news reports have raised a substantial question about who has authority to run the Department of Veterans Affairs (“VA”) in the wake of Dr. David Shulkin’s departure from the agency.  According to the White House, Dr. Shulkin resigned.  Meanwhile, Dr. Shulkin himself has publicly insisted that he did not resign and was instead fired. … Continue Reading

GSA Unveils Plan for Commercial Online Shopping Portal

Following instructions from Congress to create a new online shopping system leveraging existing commercial practices, the General Services Administration (“GSA”), in coordination with the Office of Management and Budget (“OMB”), has released an implementation plan (“Plan”) to begin e-commerce purchases by 2019.  As discussed in a previous blog post, GSA’s Plan is a first step … Continue Reading

Oregon HB 4005: New Reporting Requirements for Drug Manufacturers, Health Insurers

On Tuesday, March 13, 2018, Oregon Governor Kate Brown signed into law House Bill 4005 (HB 4005), which imposes substantial new state reporting requirements on pharmaceutical manufacturers regarding drug pricing, including details on manufacturer-sponsored patient assistance programs. HB 4005 also imposes new reporting requirements on health insurers and establishes a temporary task force charged with … Continue Reading

The Long-Standing TAA “Substantial Transformation” Standard for Drug Products is Challenged at the Court of International Trade

A generic pharmaceutical distributor, Acetris Health, LLC, has challenged the Final Determination of U.S. Customs and Border Protection (“Customs”) that Acetris’ generic prescription drug, Rosuvastatin Calcium Tablets (“Rosuvastatin”), is a product of India, the place where the active pharmaceutical ingredient (“API”) is produced.  If successful, the challenge in the U.S. Court of International Trade (“CIT”) … Continue Reading

DIUx and DoD Other Transaction Prototype Agreements: The Fast Track to DoD Funding

On February 7, the Department of Defense (DoD) awarded REAN Cloud a contract valued at up to $950 million to work with defense agencies to migrate existing applications to commercial cloud solutions. The award is of significant relevance to efforts currently underway in connection with the upcoming DoD Joint Enterprise Defense Infrastructure—or “JEDI”—procurement. However, the … Continue Reading

Incoming! Issuance of 1,000 Notifications Portends Ramp-Up of OFCCP Enforcement Activity

On February 1, the Office of Federal Contract Compliance Programs (OFCCP) issued 1,000 corporate scheduling announcement letters (CSALs) to federal contractors, a move that suggests a renewed emphasis on the agency’s enforcement of anti-discrimination and affirmative action employment laws. CSALs are informal notices that precede the official initiation of an OFCCP compliance evaluation, but the … Continue Reading

Recent Support of Countermeasure Development Poised to Continue in Reauthorization of PAHPA

The U.S. Government has recently taken a number of steps to reinvigorate its support of medical countermeasure development. In particular, by pursuing new methods of contracting, updating regulatory frameworks, and establishing additional incentives for capital investment, the U.S. Government has confirmed that countermeasure development remains a critical component of public health preparedness. Now, over the … Continue Reading

DARPA Targets Animal-Based Viral Threats in Solicitation for PREEMPT Program

On January 19, the Defense Advanced Research Projects Agency (“DARPA”) issued a new solicitation in the form of a broad agency announcement for the Preventing Emerging Pathogenic Threats—or “PREEMPT”—program. The program will be managed by the DARPA Biological Technologies Office, which generally supports activities that integrate biology, engineering, computer science, physical sciences, and mathematics. The … Continue Reading

GSA Hears Comments from Industry About e-Commerce Portals

As part of ongoing efforts to create an online marketplace for government purchasers, GSA officials held a public meeting yesterday to discuss potential market structures and legal requirements. A wide range of stakeholders attended the hearing, responding to questions from GSA on issues such as how many online portals should be implemented, who should have … Continue Reading

Online Shopping for Government Contracts? GSA Invites Industry to Comment on Its Upcoming e-Commerce Portals

In an effort to create a new online market for government contracts, the General Services Administration (“GSA”) has invited industry to comment on the development and design of e-commerce portals for commercial procurements. GSA’s request for comments will be published tomorrow, December 15, 2017.  This comment period provides a valuable opportunity for contractors to advise … Continue Reading

California Law Aims to Scrutinize Drug Pricing

Over the last few weeks, much attention has been paid to California’s recently enacted SB 17, legislation that requires pharmaceutical manufacturers to report certain price increases of prescription drugs and, in some cases, provide a justification for such increases. The legislation also requires health insurers and health plans to report additional rate information to state … Continue Reading

Protecting Intellectual Property as Government R&D Funding Rises

The U.S. Government’s research and development (“R&D”) spending is on the rise.  For instance, the U.S. Government spent $139 billion in on R&D in FY 2015 and approximately $148 billion in FY 2016.  It is slated to spend as much as $154 billion on R&D in FY 2017.  With this funding comes great opportunities for … Continue Reading

Senate Committee Directs DoD to Reduce Drug Prices

In its Report on the National Defense Authorization Act for Fiscal Year 2018, the Senate Armed Services Committee (the “Committee”) included an “Item of Special Interest” directing the DoD to exercise its rights under the Bayh-Dole Act “to authorize third parties to use inventions that benefited from DOD funding whenever the price of a drug, … Continue Reading

Department of State Releases 2017 TIP Report

The Department of State has released its 2017 Trafficking in Persons (“TIP”) Report.  As with prior versions of the annual report, the State Department reviewed efforts made by more than 180 countries to address the minimum Prosecutorial, Protective, and Preventative standards necessary for effective anti-trafficking measures, as these standards are outlined in the United States’ … Continue Reading

DHS Elaborates on its Anticipated Request for Border-Wall “Prototypes”

Last week, we reported that the Department of Homeland Security, Customs and Border Protection (CBP) had published a presolicitation notice announcing its intent to issue a solicitation “for the design and build of several prototype wall structures in the vicinity of the United States border with Mexico.”  On Friday, March 3, CBP amended that notice “to … Continue Reading

DHS Announces Intent to Award Contracts for Border-Wall “Prototypes” by Mid-April

On Friday, February 24, 2017, the Department of Homeland Security, Customs and Border Protection published a presolicitation notice announcing its intent to issue a solicitation “for the design and build of several prototype wall structures in the vicinity of the United States border with Mexico.”  At least on the government procurement front, this notice marks … Continue Reading

Trump’s Commitment Against Human Trafficking Brings Greater Uncertainty for Contractors

Last Thursday, President Trump and his senior advisors met with representatives of organizations committed to fighting human trafficking. As reported by several news outlets (e.g., AP, NYT, and Reuters), the President stated during the meeting that he would commit the “full force and weight” of the U.S. government against what he views as an “epidemic” of … Continue Reading

DARPA Seeks to Establish New Platforms for Rapid Development of Medical Countermeasures

Last week, the Defense Advanced Research Projects Agency (“DARPA”) issued a new broad agency announcement (“BAA”) seeking proposals to support the creation of an integrated “capability platform” for the delivery of medical countermeasures to prevent a pandemic threat within sixty days of targeting a known or newly emerging pathogen.  The BAA confirms DARPA’s commitment to … Continue Reading

Endgame for the Blacklisting Order

Congress recently began the process to legislatively overturn the regulations implementing President Obama’s “Fair Pay and Safe Workplaces” Executive Order.  Under the Congressional Review Act, Congress can dismantle regulations that were finalized in the waning days of a presidential administration.  Our colleagues in the Public Policy & Government Affairs practice provide some details of the … Continue Reading

New Guidance on Contractor Risk Management Under the Human Trafficking Rule Released

On December 7, the Office of Management and Budget, the Department of Labor, and the Office to Monitor and Combat Trafficking in Persons in the Department of State, issued a proposed memorandum titled “Anti-Trafficking Risk Management Best Practices & Mitigation Considerations.”  The document is intended, at least in part, to “promote clarity and consistency in … Continue Reading
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