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.

An article published March 25 by Stefanie Dodt and Samuel Gilbert in The Guardian continues the authors’ intentional maligning of plasma donors along the U.S.-Mexico border and perpetuates a divisive misrepresentation of the reality of border life between the United States and Mexico. The Plasma Protein Therapeutics Association (PPTA) and its member companies are grateful for every plasma donor, each of whom directly contributes to saving and improving the lives of people facing serious, inherited, and life-threatening diseases.

Dear Administrator Verma,

I am writing to ask for your consideration as the Centers for Medicare and Medicaid Services explores avenues to protect vulnerable patient populations during the COVID-19 pandemic. The Plasma Protein Therapeutics Association (PPTA) is the standard setting and global advocacy organization that represents plasma donation centers and manufacturers of plasma protein therapies. Our membership accounts for approximately 80% of plasma therapies in the United States. These therapies treat individuals with rare, chronic, and life-threatening conditions, such as immune deficiencies, certain neurological diseases, alpha-1 antitrypsin deficiency, and bleeding disorders.

At this time of global concern regarding spread of the novel coronavirus, PPTA wants to thank the millions of committed plasma donors who make lifesaving medicines for rare disease patients a reality and to remind them that donor safety continues to be a top priority for PPTA and its member companies. 

We also want current and potential new donors to know that:

• plasma donation continues to be a safe process,
• there have been no blood-borne transmissions of the coronavirus, and
• the need for plasma donations is just as great as ever!

At this time of global concern regarding spread of the novel coronavirus, PPTA wants to thank the millions of committed plasma donors who make lifesaving medicines for rare disease patients a reality and to remind them that donor safety continues to be a top priority for PPTA and its member companies. 

PPTA considers that the SARS-CoV-2 outbreak is not a concern for the safety of plasma protein therapies manufactured by PPTA member companies. The assessment is shared by notable international and national public health bodies, including the WHO, the ECDC, and others.