Kelly unveils bill to more quickly make generic insulin available

U.S. Rep. Mike Kelly (R-PA) on Sept. 9 sponsored legislation to make affordable generic insulin and its analogues more widely available in a shorter amount of time for millions of American diabetics.

“Historically, generic options are substantially cheaper and force down drug prices across the board. The same can and should be true of insulin,” said Rep. Kelly, vice-chair of the Diabetes Caucus and a diabetic himself.

Rep. Kelly on Monday unveiled the Market Access for Generic Insulin Competition (MAGIC) Act of 2019, H.R. 4244, which would provide a pathway for chemically synthesized insulin to be approved under an abbreviated new drug application (ANDA), according to the congressional record.

“The average annual cost of insulin for a type 1 diabetic has increased 600 percent over the last two decades,” Rep. Kelly said. “Millions of Americans are struggling to afford a drug they depend on to live, and many are dangerously resorting to rationing their prescriptions.”

If enacted, H.R. 4244 would establish a permanent approval process at the Food and Drug Administration (FDA) for generic insulin production via the ANDA process.

“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,” said the congressman.

In July, Rep. Kelly had requested detailed information from the FDA on why insulin was omitted from the agency’s list of synthetic peptide drug products, which are eligible for generic approval through the ANDA process.

However, to date, the FDA has not responded despite repeated follow-up by Rep. Kelly’s staff.