Eli Lilly Claims Innocence as FDA Bans Mystery Cialis-Viagra Concoction Discovered at Plant
January 13, 2015
By Mark Terry, BioSpace.com Breaking News Staff
The U.S. Food and Drug Administration yesterday announced it had issued an import block on Eli Lilly and Co 's Cialis pills. Apparently the block only applies to Cialis imported from Eli Lilly Pty Ltd in Australia.
The alert stated, “Sample analysis of the aforementioned product found the product to contain tadalafil and sildenafil. Although Cilias [sic] is currently an approved new drug product; the current application does not include the combination of tadalafil and sildenafil. As such; the aforementioned product appears to be an unapproved new drug.”
It’s not quite as clear-cut as the FDA statement would suggest. It seems more likely that there is some sort of product tampering involved. Tadalafil is the active ingredient in Cialis, manufactured by Eli Lilly. Sildenafil is the active ingredient for Viagra, manufactured by Pfizer Inc. . Both medications are for erectile dysfunction. They appear to originate from an Eli Lilly facility in the Sydney, Australia suburb of West Ryde. But Lily doesn’t operate a manufacturing plant in Australia. Any Cialis products origination from Australia are counterfeit.
“Lily does not manufacture Cialis in Australia,” said Eli Lilly spokeswoman Celeste Stanley in a statement. “In fact, Lilly does not currently operate a manufacturing site in Australia for any of its products. Thus, any Cialis product with packaging stating it is from Lilly in Australia is not genuine. This appears to be a counterfeit version of Cialis.”
This follows a decision in early 2014 by Lilly to invest more than $100 million to meet global counterfeiting regulations. This investment would, according to Bill Reid, senior director, global anti-counterfeiting at Lilly, in a statement, assist with “emerging track and trace standards in the U.S., Europe and other markets that implementing serialization.”
Other techniques Lilly is using to fight counterfeiting includes using color-shifting blister packs. Other firms are using holograms in their packaging.
“We’re seeing counterfeit products in a number of therapeutics areas—including erectile dysfunction, oncology and mental health,” said Derek Walmsley, regional general manager for Lilly’s global product security team, in a statement. “And it isn’t limited to any specific geographic area. The increasing incidence in a number of countries, as well as [of fake] oncology products, is of great concern—it’s a risk to patient safety. For example, we’ve seen counterfeit oncology medicines in Latin America and China.”