Capitol Correspondence - 02.25.20

New FDA Definition for Some Types of Drugs Could Lead to Cheaper Insulin Prices

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Politico Pro reported on a new move by the Food and Drug Administration that has the potential to lower the cost of insulin. This is of interest to the disability community, given the high amount of people with disabilities who also have diabetes. Specifically, Politico Pro reports that:

“FDA today issued a final definition of the term ‘biological product’ — an action the agency says should make it easier to get cheaper insulin on the market, but which critics say might mean slower licensing of lower-cost drugs in the future.

The rule lines up FDA’s policies with a 2019 spending bill in which Congress inserted language to reclassify ‘chemically synthesized polypeptides’ as biological products instead of small molecule drugs.

Obamacare had defined a biological product as a protein other than a chemically synthesized polypeptide, which left uncertainty about the status of insulin and some other drugs. FDA Commissioner Stephen Hahn said the final rule would open new pathways for manufacturers to market biosimilar and interchangeable versions of drugs such as insulin. This could bring down prices, he said in a news release.

In addition to insulin, an FDA Q&A document notes that growth hormone, certain fertility drugs and others would be regulated as biologics beginning on March 23. FDA has argued that the generic drug pathway is not designed to enable copycat applications for complex proteins such as insulin, where generic versions may not be identical to the original.

But while the rule change could make it easier to market copycat insulin and other drugs whose market exclusivity has long expired, it will now take longer to get copies of new complex drugs on the market. Makers of biological products will have 12 years of exclusive marketing rights, compared with five years of exclusivity for small molecule drugs.”