One day you are providing patients safe and effective prescription cancer medications and the next those same drugs are unavailable—without warning or explanation. Such is the state of the national drug shortage, which is reaching epidemic proportions.
On October 31, 2011, President Obama issued an executive order, Reducing Prescription Drug Shortages. Executive orders are presidential regulations that give government offices or agencies administrative authority to interpret and implement provisions of the constitution, law, or a treaty.
The order addresses shortages that affect “cancer treatments . . . and other drugs that are critical to the treatment and prevention of serious diseases and life threatening conditions” that need to be accessible to healthcare providers.
It further states that certain cancer treatments have “increased by about 20%, without a corresponding increase in production capacity,” and that “interruptions in the supplies of these drugs endanger patient safety” and limit treatment options.
With the force of law, the U.S. Food and Drug Administration (FDA) has now been directed “to prevent and reduce current and future disruptions in the supply of lifesaving medications.” Specifically, the order instructs the FDA to
Work with “manufacturers to provide adequate advance notice” when discontinuances are imminent.
“Expand its current efforts to expedite its regulatory reviews” over drugs.
“Communicate to the Department of Justice any findings that shortages have led market participants to stockpile” drugs that would cause price gauging.
Alec Stone, MA, MPA, is the health policy director for the Oncology Nursing Society. With more than 20 years of political and policy experience, he continues to be a voice for health professionals, patient access, and affordable care. Holding a master’s in public administration and a master’s in political management, he understands the policy and political aspects of advocacy.