PPTA Responds to July 24 White House Executive Orders
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.
Importation from Canada and other foreign countries has been objected to by more than 11 former FDA Commissioners and is subject to safety concerns like drug counterfeiting. Plasma protein therapies are biological products subject to special restrictions on transportation and shipping. Any drug importation program must exclude these biologically based plasma protein therapies.
Innovation and a commitment to patients during the Covid-19 pandemic is essential, and PPTA member companies and employees have devoted significant resources and cutting-edge research to solving the problem. PPTA continues to ask Secretary Azar and President Trump to not include plasma protein therapies in any program that limits or selects the PPTs that U.S. patients need or jeopardizes the safety of PPTs.
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