Kelly to President Trump: We Must Act Now to Make Insulin Affordable

Nov 21, 2019

Washington, D.C. - Today, U.S. Representative Mike Kelly (R-Pa.) wrote to President Donald Trump requesting his help addressing the ongoing insulin affordability crisis. Kelly, vice-chair of the Congressional Diabetes Caucus and a diabetic himself, urged the president to declare the nationwide lack of affordable insulin a public health emergency. He also requested the president's support for H.R. 4244, the Market Access for Generic Insulin Competition (MAGIC) Act, legislation Kelly authored to create a clear and permanent approval pathway at the FDA for U.S. manufacturers to produce affordable generic insulin

"Mr. President, you can take decisive, executive action to begin fixing this problem. You can help those suffering from diabetes in America who cannot afford life-saving insulin," wrote Kelly after outlining regulatory barriers to generic insulin. "The March 23, 2020, transition date is a mere four months away, and diabetics need help now. I look forward to working with you and my colleagues in Congress on this matter of critical importance to millions of Americans."

Read the Congressman's letter here


Insulin was discovered in 1921.  After nearly a century, there are only three companies that manufacture the drug while the number of people who need it has increased exponentially.  U.S.-based generic drug makers indicate that contemporary technological advancements have made it possible to use chemical synthesis to produce exact copies of insulin.  In simple terms, a true, lower-priced generic insulin option is closer to realization than ever before.  However, among other obstacles, FDA regulatory uncertainties have been a roadblock to new companies entering the market with this technology to improve the lives of American diabetics.

In 2017, the FDA released a list of synthetic peptide drug products eligible for generic approval through the ANDA process.  Insulin, a complex peptide, was not included in this list. Representative Kelly believes that President Trump can act under his existing statutory authority to add insulin to this guidance and provide a clear albeit temporary pathway for generic drug makers to apply for approval for generic insulin.

Insulin’s omission from the 2017 guidance and the FDA’s bureaucratic inertia have real-world consequences as they are hindering a potentially major solution to the insulin rationing crisis. Soon, the opportunity to obtain approval for generic insulin production will permanently close if current law is not changed.  The Biologics Price Competition and Innovation Act of 2009 stipulates that on March 23, 2020, insulin will be removed from the FDA’s list of approved drug products (Orange Book) and reclassified as a biological product (Purple Book).  Manufacturers will then be barred by law from applying for approval to make a generic insulin product, instead having to apply to produce “biosimilars.”  As the name suggests, biosimilars are not identical copies (while chemically synthesized insulin is identical to the brand insulin currently being sold commercially). Therefore, new insulin manufacturers will be forced to undergo a new, expensive, years-long, and generally uncertain application process for a different product that will further delay critically needed competition in the insulin market. With the technology to safely and effectively replicate insulin ready today, such a delay is unnecessary and harmful.

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