Kelly Introduces MAGIC Act to Make Generic Insulin a Reality

Sep 10, 2019 Issues: Health Care

Washington, D.C. — Today, U.S. Representative Mike Kelly, R-Pa., vice-chair of the Diabetes Caucus and a diabetic himself, unveiled H.R. 4244, the Market Access for Generic Insulin Competition (MAGIC) Act of 2019.  If enacted, this bill would pave the way for the approval and production of true, affordable generic insulin (and its analogues) for American diabetics.

“The average annual cost of insulin for a type 1 diabetic has increased 600% over the last two decades,” said Kelly.  “Millions of Americans are struggling to afford a drug they depend on to live, and many are dangerously resorting to rationing their prescriptions.  The MAGIC Act will ensure that federal law and regulatory barriers at the FDA no longer stand in the way of a competitive market for insulin.  Historically, generic options are substantially cheaper and force down drug prices across the board.  The same can and should be true of insulin.”

The MAGIC Act will establish a clear and permanent approval pathway at the Food and Drug Administration (FDA) for generic insulin production via the abbreviated new drug application (ANDA) process.  Doing so will remedy a consequence of current law that permanently closes the door on generic insulin production after March 2020.  Further details on this are below.

Background

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 for reasons unknown.  Because insulin appears to meet the FDA’s qualifications for a peptide drug, Rep. Kelly wrote to FDA Acting Commissioner Ned Sharpless on July 16, 2019, requesting detailed information as to why it was omitted.  The FDA has not yet responded to the congressman’s letter despite repeated follow-up by staff.

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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