On April 2, FDA Commissioner Scott Gottlieb issued a statement outlining the agency’s plans to increase competition in order to bring down the price of insulin. Here are five takeaways from that statement.
1. Insulin prices in the crosshairs
This is the first time that Commissioner Gottlieb has issued a statement specifically about insulin prices since he began his tenure with the FDA in March 2017. He previously spoke pointedly about the price of insulin within larger discussions on high drug prices and the role of biosimilars to boost competition.
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The commissioner’s statement came on the same day that Congress held a hearing specifically on insulin costs, and a week before another hearing is to be held in which executives from insulin-making companies will be asked to justify those prices. In addition, insulin prices have been a focus of two earlier Congressional hearings on drug costs.
2. Biosimilars to drive down drug prices?
In the statement, Commissioner Gottlieb outlined how the FDA plans by 2020 to re-classify insulin as a biologic; it is currently classified as a drug. He argues this regulatory shift will clear hurdles for drug companies to bring interchangeable biosimilar insulins to market and drive down prices.
3. Gottlieb not going quietly
Commissioner Gottlieb announced in March that he planned to resign by the end of the month. That timeline seems to have been extended, at least for a few days, as this statement arrives in April. The statement could be seen as publically planting a policy flag for the next FDA commissioner – a signal that the agency considers lowering the price of insulin a priority.
4. Softened tone towards drug companies?
However, it should be noted that the commissioner avoided some of the more heated rhetoric he employed when he last spoke publicly about this issue on December 11th, 2018.
In that December policy speech, he accused drugmakers of gaming patent laws and unfairly blocking generic competition. In this more recent statement, he seems to extend an olive branch and leave a door open for partnership, saying, “The FDA is dedicated to facilitating access to insulin. We hope our industry partners will join us in doing all we can to help people who need access to the live saving medicines, now.”
5. He announces a hearing about the FDA’s plan to bring insulin biosimilars to market.
The day-long hearing will be held on May 13th, 2019. Public comment also will be open for the proposed rule changes until May 31st, 2019. You can find more information on the hearing here.