Increase plasma supply by harmonizing state regulations


Plasma donation centers are regulated by states and the federal government, and some states have enacted regulations that exceed the U.S. Food and Drug Administration's (FDA) plasma donation regulations. These federal standards allow plasma donation centers to operate efficiently and safely for donors and recipients of donated plasma. State regulations that require increased staffing numbers or higher credentials than needed for the job impact the efficiency and productiveness of plasma centers. With the increased use of plasma-derived therapies for many types of conditions, from immune deficiencies to neuromuscular diseases, the need for source plasma, and thus more plasma donation centers, is critical. 

FDA states that laboratory directors for plasma donation centers have to be physicians or a physician substitute, meaning a trained and qualified person who is: 

  1. A graduate of an education program for healthcare workers that includes clinical training.
  2. Currently licensed or certified as a healthcare worker in the jurisdiction where the collection establishment is located.
  3. Currently certified in cardiopulmonary resuscitation (CPR).
  4. Trained and authorized under state law, and/or local law when applicable, to perform the specified functions under the direction of the responsible physician.

Misalignment of state regulations creates challenges for national plasma companies and reduces the incentive for companies to build more centers. Connecticut currently has only one plasma donation center operating within the state due to the added obstacles its regulations pose. One of the main obstacles is that the center director must have at least one year of specialized training in blood banking. Not only is this specialization extremely rare, but source plasma donation centers do not perform blood banking activities. 

Pennsylvania requires a plasma donation center laboratory director to have 10-15 years of plasma center experience and a Ph.D., and they must be on site during open hours. This added guideline for qualifications and supervision makes it more difficult for companies to recruit lab directors in Pennsylvania because of the high demand and low supply of individuals meeting those standards. 

States with overly burdensome regulations also create unnecessary obstacles for individuals who wish to donate their plasma. Recently, Pennsylvania signed legislation into law to align with federal regulations, and in May, Connecticut passed legislation to better align with federal requirements as well. Vermont and New Hampshire are two states where legislators still need to bring forth updated regulations. Both states currently have zero plasma donation centers.

With the demand for plasma and plasma-derived products growing each year, a consistent supply of source plasma is critical. Only source plasma from volunteer donors can be used to create plasma-derived therapies. State regulations play an important part in maintaining safe plasma donation; however, they can also be unnecessarily burdensome, leading to fewer donation centers, operational inefficiencies, and, ultimately, decreased plasma donation. Above all, plasma donation regulations must prioritize the safety of donors providing plasma and the patients whose lives depend on it, which the federal standard does.

Patient advocacy groups including the Immune Deficiency Foundation, the GBS/CIDP Foundation, and the National Bleeding Disorders Foundation work to educate legislators and state agencies on the role of plasma donation in creating the lifesaving therapies rare disease communities rely upon.

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