Kelly calls America’s shortage of cheaper insulin a public health emergency

U.S. Rep. Mike Kelly (R-PA), vice-chair of the Congressional Diabetes Caucus and a diabetic himself, last week urged the president to declare the nation’s lack of affordable insulin a public health emergency.

“Mr. President, you can take decisive, executive action to begin fixing this problem,” Rep. Kelly wrote in a Nov. 21 letter sent to President Donald Trump. “You can help those suffering from diabetes in America who cannot afford life-saving insulin.”

Currently, only three companies manufacture insulin, with just one located in the United States, while the number of people who need it has increased exponentially, according to Rep. Kelly’s letter.

At the same time, there are no generic insulin options available and bureaucratic red tape at the U.S. Food and Drug Administration (FDA) has roadblocked market access for new companies having advanced technology capabilities to make generic insulin, according to his letter.

“Because of this lack of competition, the price of insulin has risen 700 percent since 2001,” wrote Rep. Kelly. “As a result, at least one in four Americans with type 1 diabetes are dangerously rationing their supply, which often leads to cascading health problems or death. This harsh reality can only be described as a healthcare crisis.”

Rep. Kelly requested that Trump encourage Congress to approve the Market Access for Generic Insulin Competition (MAGIC) Act, H.R. 4244, which he authored and introduced in September to create a permanent federal approval pathway for U.S. manufacturers to produce affordable generic insulin.

“The MAGIC Act is crucial,” wrote Rep. Kelly, because federal law “mandates that on March 23, 2020, insulin will be removed from the FDA’s list of approved drug products… and officially reclassified as a biological product. As a result, drug manufacturers will be statutorily barred by law from applying to make a generic insulin product of any kind.”

Rep. Kelly also urged the president to direct the U.S. Secretary of the Health and Human Services Department to officially declare America’s lack of cheaper insulin as a public health emergency.

Based on that declaration, the president should then issue an executive order directing the FDA to add insulin and its analogues to its list of synthetic peptide drug products eligible for generic approval through the Abbreviated New Drug Application process, an action that Rep. Kelly wrote “would give generic drug makers a clear regulatory path for filing for approval until March 23, 2020.”