The Plasma Protein Therapeutics Association (PPTA) is pleased by recent actions taken in California and New York, two of the most populous states in the country, that show the growing recognition of the importance of plasma donation. In New York, the Department of Health released emergency regulations that revise requirements for the Collection of Blood Components. These revisions simplify the regulatory landscape for source plasma¹ donation in New York by harmonizing New York State requirements with national standards. The changes should enhance plasma availability, while maintaining high blood safety standards.

On Wednesday, September 23, at the invitation of the U.S. International Trade Commission (USITC), PPTA President & CEO, Amy Efantis testified before the USITC at a virtual hearing on COVID-19 Related Goods: The U.S. Industry, Market, Trade, and Supply Chain Challenges. The main messages that PPTA conveyed were that the plasma protein therapeutics industry is built on a complex, global supply chain that must be preserved to ensure access for the patients that depend on it. Additionally, it is of vital importance that the Administration continue to support policies that encourage plasma donation.

The most recent White House executive order, issued September 13 and calling for a “most favored nation” Medicare drug pricing program, is ill-advised and risks the lives of vulnerable U.S. patients who rely on access to plasma protein therapies (PPTs). PPTs are non-interchangeable, single-source products which might not be available in some reference countries. 

The Plasma Protein Therapeutics Association is steadfast in its mission to promote the availability of, and access to, safe and effective plasma protein therapies for patients around the world. We call on all eligible adults to donate plasma – whether you are someone recovered from COVID-19 or not, your plasma is needed to save lives, now. By donating plasma today, you are directly helping to save the lives of babies born with primary immune deficiencies, bleeding disorders, and other rare conditions, as well as patients who rely on plasma therapies in emergency and critical-care contexts.

Yesterday, President Trump, senior officials within his Administration, and representatives from the plasma and blood communities agreed that plasma donation is a national imperative, recognizing how essential plasma is and urging Americans to donate their plasma. Paul Perreault, Chief Executive Officer and Managing Director of CSL Ltd. represented the CoVIg-19 Alliance, “an unprecedented partnership of world-leading companies” dedicated to the development of a hyperimmune globulin with the potential to treat people seriously impacted by COVID-19. He took the opportunity presented by participating in the White House Roundtable to issue a call for all Americans to donate plasma, even those who have not had COVID-19, and to urge the Administration to support the industry’s effort to develop a hyperimmune to combat COVID-19.

White House executive orders issued on July 24 calling for a “favored nations” and drug importation program are ill-advised and risk the lives of U.S. patients who rely on access to plasma protein therapies. These unique, non-interchangeable and lifesaving therapies treat patients with rare diseases such as primary immune deficiency and bleeding disorders, like hemophilia. The executive order on favored nations would use pricing schemes from countries that often do not make the PPTs used by U.S. patients available, often selecting only one representative drug in a category and artificially setting prices.

Dear Editor,

The article published May 3, “Researchers Explore Using Common Blood-Plasma Treatment to Fight Coronavirus,” calls necessary attention to the importance of intravenous immunoglobulin, IVIG, as a lifesaving therapy for people living with a range of serious, genetic, and chronic conditions. Increased use of IVIG as an untested treatment against COVID-19 risks limiting its availability for those patients whose lives rely on regular access to it. For many of these conditions, IVIG remains the only known treatment.

President Trump made an appeal for plasma donation a few days ago and is echoing what people with serious, genetic, life-threatening diseases already know —plasma donors save lives! Most people had not given much thought to plasma before the recent COVID-19 pandemic. Now, they are learning that plasma from a patient who has recovered from COVID-19 could be used to make therapies to treat others who are sick with the disease and could eventually be used to safeguard health care workers.

An article published on April 15 by The Huffington Post details a plasma donor’s experience in light of health precautions caused by the spread of COVID-19. The Plasma Protein Therapeutics Association (PPTA), our members, and our patient stakeholder partners all agree, as do authorities across the United States and European Union, that plasma donors and plasma donation center staff are essential parts of our expansive health care infrastructure, especially during these difficult times.

PPTA is aware of the guidance documents released by the U.S. Food and Drug Administration on April 2 regarding Source plasma donor eligibility and is currently evaluating them. Our focus remains, as it has for nearly three decades, on patient and donor safety, and the safety of therapies derived from plasma.