While the summer days are starting to be numbered, at the Coalition we are not letting off the gas pedal in terms of bringing you the most up to date and relevant contracting and market information for your Federal business. We will continue with our Lunch and Learn webinars well into Fall and have several exciting topics for September that you can read about and register for below. In addition to these webinars, we are also in the process of scheduling training on Tier 4 DrugsCMMC, and Section 889, and welcome your thoughts on other timely topics you would like for us to address.

Lastly, I want to again remind you that we are moving our Fall Healthcare Procurement Training Conference (November 17) and regular Fall Training Conference (November 18) to a virtual environment. The Fall Training Conferences will examine the election results and highlight the expectations for, and impact on, the Federal market.  We will also take a look back and a look forward at the ongoing response to the pandemic. In addition, members should look forward to hearing from our legal panel outlining the key legal, regulatory and compliance developments of 2020. Expect to see virtual breakout sessions focusing on key procurement programs. Much more to come so look for future announcements about the full agendas in the Friday Flash.

*September 2 from 12:00 – 1:00pm EST: Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States: What It Means for Pharmaceutical Manufacturers and the U.S. Food and Drug Administration (McDermott Will & Emery)

McDermott Will & Emery will provide a look at how the EO establishes a policy of decreasing reliance on foreign manufacturers for certain medical products (including pharmaceuticals) through a series of changes to procurement priorities.  James will focus on those changes that may result in significant limits to current manufacturing processes outside the U.S. for pharmaceutical manufacturers and distributors as well as the potential impact of changes awardee selection requirements.  Brian will address the broad scope of the unfunded mandate to the U.S. Food & Drug Administration under the EO, the requirements related to areas not traditionally regulated by the agency as well as impact of uncertainty regarding the resulting changes for the pharmaceutical industry.

*September 3 from 12:00 – 1:00pm EST: Pricing Training for Covered Drugs (Hogan Lovells and Orlaithe Consulting

Hogan Lovells and Orlaithe Consulting will present best practices and issues to consider in preparation for the upcoming Veterans Health Care Act of 1992 (VHCA) “Public Law” season. They will discuss the required price calculations and price reporting requirements as well as necessary Federal Supply Schedule contract updates.  Additionally, they plan to cover recent developments relating to FSS pharmaceutical contractors, including the new FAR rule regarding certain telecommunications equipment and services, VA statements regarding state and local government purchases, and anticipated guidance from VA regarding the definition of “covered drug” under the VHCA.

*September 15 from 12:00 – 1:00pm EST: Update Webinar on beta.SAM.gov with Assistant Commissioner Judith Zawatsky (GSA)

Assistant Commissioner Judith Zawatsky will bring you up-to-date and answer questions about the modernization effort. The new website already has integrated several legacy systems (CFDA.govWDOL.govFBO.gov) and is about to integrate the reporting functions from FPDS.gov (only the reporting functions are moving over; the rest of FPDS.gov is staying in place for now). Next up will be the transition of legacy SAM.gov into beta.SAM.gov.

*September 17 from 10:00am – 12:00pm EST: Trillions in Taxpayer Funds: The Next Phase – Fraud, Investigations, and False Claims (Mayer Brown).

Over the past months, statutes representing massive efforts to support the economy and business have been enacted. Agencies have been provided new authorities, existing authorities have been relaxed, and government has distributed vast sums to companies through various methods, including procurements, loans, loan guarantees, and grants. This forum will explore the risks associated with these actions and the inevitable investigations and claims of fraud that are likely to arise from participation in these programs.

*September 22 from 12:00 – 1:00pm EST: Update on OTAs (Miller & Chevalier Chartered)

Miller & Chevalier will be discussing everything OTAs, including a brief overview of the history of OTAs and important highlights and red flags to be aware of when contracting with the government using OTAs. Topics will include eligibility, considerations when negotiating proprietary rights under OTAs, and planning for the potential for a sole source follow-on production contract.

*September 24 from 12:00 – 1:00pm EST: Small Business Subcontracting Plans and Flow Down Clauses (Holland & Knight).  More information coming soon!

We hope that you will join us for our Lunch and Learn series webinars throughout the month of September.  If you have any questions about registration, please contact Michael Hanafin at mhanafin@thecgp.org.