Recent Correspondence with Regulators in the U.S. and EU

U.S. Federal

  • August 4: PPTA submitted a letter to Honorable Alex Azar, Secretary of the U.S. Department of Health & Human Services "Proposed Urgent Regulatory Actions to Increase Source Plasma Collections."
  • May 22: PPTA and Member companies sent a letter to Senate Majority Leader Mitch McConnell, Speaker of the House of Representatives Nancy Pelosi, Senate Minority Leader Charles Schumer, and House Minority Leader Kevin McCarthy encouraging support for amending Section 3226 of the CARES Act to include "plasma".
  • March 18: PPTA's letter to Centers for Medicare and Medicaid Services Administrator Seema Verma urged the agency to take measures allowing for home infusion of plasma protein therapies by vulnerable patients.
  • March 12: PPTA's letter to U.S. Secretary of Health and Human Services Alex M. Azar and Assistant Secretary for Health ADM Brett P. Giroir, M.D., urged the need to protect the supply chain for plasma protein therapies by maintaining the essential equipment and materials for plasma collection.

U.S. States

  • April 21: PPTA's letter to New York Governor Cuomo requesting that any economic recovery package include language currently embodied in bill A.9915/S.7811, as well as a request for an executive order that allows plasma collection in the state of New York pursuant to federal law.
  • April 7: PPTA's letter to the Ohio Department of Health regarding current COVID-19 crisis and its impact on plasma donations in the entire United States including Ohio.
  • March 20: A PPTA letter to state governors across the U.S. shared that plasma donation centers are critical infrastructure, and the participation of plasma donors and center employees in the collection process is essential, according to the U.S. Department of Homeland Security.

European Union

  • July 23: PPTA submitted a letter to the European Commission regarding the use of the EU Emergency Support Instrument for the collection of COVID-19 convalescent plasma.
  • April 16: PPTA letter to Czech Ministry of Health regarding a national contingency plan on the collection of plasma and blood (English, Czech)
  • April 14: PPTA letter to Austrian Authorities asking for priority access to PPEs and call for plasma donation (German, English)
  • April 9: PPTA statement to the draft ordinance to secure the supply of medical products (German, English)
  • April 8: PPTA letter to the Federal MoH and to the regional MoH's respectively regarding the supply with PPE (German, English)
  • PPTA, Pharmig, and IG Plasma submitted a joint letter to the Austrian Ministry of Health urging the government to promote plasma donation as an essential portion of healthcare infrastructure and that plasma donation centers be exempted from lockdown measures.
  • PPTA's letters to Czech (March 17), German (March 19), and Austrian (March 19), and Hungarian (March 24) policymakers all advocated for the essential, critical nature of plasma collection and plasma donation centers. They urge the policymakers in the respective countries to include plasma collection in the list of essential infrastructure that must be maintained and open during the current pandemic.
  • March 16: PPTA’s second letter urged the European Commission to recognize plasma and pharmaceutical intermediates as essential products.
  • March 13: PPTA's first letter to the European Union’s Coronavirus Response Team emphasized the need to continue collecting plasma during this crisis to ensure the continued availability of plasma-derived medicinal therapies.
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