FDA Warns Eli Lilly Over Humalog

CNN is reporting that the US FDA has sent Eli Lilly a warning letter about problems with their production of Humalog at a plant in Puerto Rico. While Lilly asserts that the changes in the Lyspro Insulin Zinc Crystals do not impact the safety or efficacy of the product, the FDA wrote in their letter:

“In addition, your firm indicated during the inspection that the (b)(4)
may cause the finished drug product to be
subpotent and have an atypical visual appearance.
Your firm’s indication
that stability data for affected batches are comparable to normal
batches appears insufficient to support safety and efficacy.
” (emphasis mine)

The (b)(4) is a redacted portion and there are many in this publicly available letter. However, it does appear that unless Eli Lilly responds quickly, the FDA may be taking action. Humalog users may want to keep their eyes and ears open for any recalls that are coming.

Read the CNN report HERE; read the letter from the FDA HERE

They’re also in trouble, in Mexico, right now… I believe from profiteering. http://www.reuters.com/article/idUSN2310744920100223

It is worth noting that the FDA’s issue is with Lilly’s company-owned insulin mfg. plant in Puerto Rico (the only one remaining in North America, incidentally), they outsource the manufacture of most vials of Humalog to a third-party manufacturer Hospira, Inc. and the Hospira-made Humalog (vials only) will not be impacted (see my blog post here for some background on that). Further, insulin pen cartridges (prefilled pens are a different matter) are made by Lilly in France, another facility that was not implicated for unsanitary (what the term “adulterated” refers to in this section of the law) manufacturing facilities – which is the section of the Federal Food Drug and Cosmetics Act cited in the FDA’s letter to Lilly del Caribe, the Puerto Rico facility implicated here. The entire FDA letter can be viewed here if you care to read it. The collusion issue in Mexico is probably a more serious issue for the company, because it could embolden U.S. healthcare insurers who have seen double-digit price increases for insulin recent years for insulin to could challenge FTC officials to consider similar actions here in accordance with antitrust law – with a Democratic leader in the White House, FTC officials have changed and the “good old days” for monopolistic companies are over for the time-being.