Pharmaceutical giant fined P16 M for importing Cialis

MANILA, Philippines - A pharmaceutical giant has been slapped a P16-million administrative fine for importing and distributing unregistered products, including the sexual enhancement drug Cialis.

Food and Drug Administration (FDA) director general Kenneth Hartigan-Go said yesterday that based on their investigation, at least 15 products distributed by Eli Lilly were “unregistered and/or have falsified product registrations.”

Aside from the Cialis 20 mg tablet, the other unregistered products cited in FDA Advisory 2014-034 were Cymbalta 30mg capsule, Humalog 100 units per ml solution for injection, Humalog Kwikpen 100 units per ml solution for injection, Humalog Mix 25 Kwikpen 100 units per ml solution for injection, Humalog Mix 25, Humalog Mix 50 Kwikpen, Stratterra 10mg capsule, Stratterra 18mg capsule, Stratterra 25mg capsule, Stratterra 40 mg capsule, Strattera 60mg capsule, Prozac 20mg capsule, Zyprexa Zydis 10mg Orodispersible tablet, and  Zyprexa Intramascular 20mg powder for injection.

“These unregistered products are ordered recalled from commerce and shall not be distributed. The safety, efficacy and quality of these products need to be established anew before they are authorized to be marketed,” Go said.

He said that Eli Lilly had violated provisions of the Food and Drug Administration Act of 2009.

“Eli Lilly has been directed to initiate steps in informing the patients and prescribers to look for alternative products. Physicians are hereby warned against prescribing these products while the public is advised to be vigilant and refrain from buying and using them,” he said.

Go added that if these products are still in the market, they should be returned to Zuellig Pharma Corp. at Km. 14 West Service Road, South Superhighway corner Edison Ave., Sun Valley, Parañaque City.

10 registered products

Meanwhile, only 10 Eli Lilly products available in the market have certificate of product registration (CPR), according to the FDA advisory.

These are the Alimta 100mg lyophilized powder for intravenous infusion, Alimta 500mg lyophilized powder for I.V. infusion, Gemzar 1g powder for injection, Cymbalta 60mg capsule, Zyprexa Zydis 5mg tablet, Forteo 250mcg per ml solution for injection, Byetta 250mcg per ml solution for injection (1.2ml) SC, Byetta 250mcg per ml solution for injection (2.4ml) SC, Effient 5mg film-coated tablet, Effient 10mg film-coated tablet.

Incorrect data

But Eli Lilly Philippines yesterday said that contrary to what is contained in the FDA advisory, the company only has 13 unregistered products and not 15 as of May 6, 2014.

It added that it has 16 registered products in the Philippines, and not 10 as the FDA had said.