IBJNews

FDA letters scold Lilly, others over marketing materials

Back to TopCommentsE-mailPrintBookmark and Share

Federal health regulators have issued enforcement letters to Eli Lilly and Co., Bayer, Amylin Pharmaceuticals and Cephalon for making inaccurate or incomplete statements while promoting their drugs.

The Food and Drug Administration on Tuesday disclosed four letters issued to the companies by its marketing enforcement division.

The letter to Indianapolis-based Lilly cites a print advertisement for the antidepressant Cymbalta, which is approved to treat depression, generalized anxiety disorder, diabetic nerve pain and the pain ailment fibromyalgia. According to the FDA, Lilly's ad did not adequately display information about the drug's side effects, a requirement for all pharmaceutical promotions.

The company said it is working to remove the materials from marketing circulation.

"Lilly is committed to providing clinically accurate and balanced promotional materials to health care professionals and patients," the company said in a statement.

The FDA's letter to Cephalon, based in Frazer, Pa., makes similar complaints about missing risk information in the company's promotional cards for Treanda, a lymphoma treatment.

The FDA says the card is "false or misleading because it omits important risk information." The drug has been linked to serious infections, skin reactions and other side effects.

A spokeswoman for Cephalon said the company has instructed sales people to stop using the card. The company has already responded to FDA's concerns and is also reviewing all marketing materials for Treanda, she added.

In the letter to Amylin, regulators take issue with statements made by the company while promoting its diabetes drug Byetta at a conference in Washington D.C. last summer. According to the letter, several statements promoted the drug for unapproved uses and "overstate the efficacy of Byetta."

San Diego-based Amylin co-markets Byetta with Lilly.

The companies said in a joint statement that they have already responded to FDA's letter and, "will take action as needed in order to ensure all product communications adhere to regulatory requirements."

Similarly, FDA reviewers said Bayer's script for a presentation on its birth control implant Mirena "overstates the efficacy" and "presents unsubstantiated claims," according to the letter.

A spokeswoman for Bayer Healthcare Pharmaceuticals said the company discontinued the promotional program last February. She confirmed that the German conglomerate's drug unit, based in Wayne, N.J., received the letter Dec. 30 and will respond by Thursday Jan. 14, as requested by FDA.

The four letters were issued on separate dates between mid-December and early January.

The FDA regularly issues letters to companies that do not follow regulations for manufacturing and marketing.

 

ADVERTISEMENT

Post a comment to this story

COMMENTS POLICY
We reserve the right to remove any post that we feel is obscene, profane, vulgar, racist, sexually explicit, abusive, or hateful.
 
You are legally responsible for what you post and your anonymity is not guaranteed.
 
Posts that insult, defame, threaten, harass or abuse other readers or people mentioned in IBJ editorial content are also subject to removal. Please respect the privacy of individuals and refrain from posting personal information.
 
No solicitations, spamming or advertisements are allowed. Readers may post links to other informational websites that are relevant to the topic at hand, but please do not link to objectionable material.
 
We may remove messages that are unrelated to the topic, encourage illegal activity, use all capital letters or are unreadable.
 

Messages that are flagged by readers as objectionable will be reviewed and may or may not be removed. Please do not flag a post simply because you disagree with it.

Sponsored by
ADVERTISEMENT

facebook - twitter on Facebook & Twitter

Follow on TwitterFollow IBJ on Facebook:
Follow on TwitterFollow IBJ's Tweets on these topics:
 
Subscribe to IBJ
  1. I had read earlier this spring that Noodles & Co was going to open in the Fishers Marketplace (which is SR 37 and 131st St, not 141st St, just FYI). Any word on that? Also, do you happen to know what is being built in Carmel at Pennsylvania and Old Meridian? May just be an office building but I'm not sure.

  2. I'm sorry, but you are flat out wrong. There are few tracks in the world with the history of IMS and probably NO OTHER as widely known and recognized. I don't care what you think about the stat of Indy Car racing, these are pretty hard things to dispute.

  3. Also wondering if there is an update on the Brockway Pub-Danny Boy restaurant/taproom that was planned for the village as well?

  4. Why does the majority get to trample on the rights of the minority? You do realize that banning gay marriage does not rid the world of gay people, right? They are still going to be around and they are still going to continue to exist. The best way to get it all out of the spotlight? LEGALIZE IT! If gay marriage is legal, they will get to stop trying to push for it and you will get to stop seeing it all over the news. Why do Christians get to decide what is moral?? Why do you get to push your religion on others? How would legalizing gay marriage expose their lifestyle to your children? By the way, their lifestyle is going to continue whether gay marriage is legalized or not. It's been legal in Canada for quite a while now and they seem to be doing just fine. What about actual rules handed down by God? What about not working on Sundays? What about obeying your parents? What about adultery? These are in the 10 Commandments, the most important of God's rules. Yet they are all perfectly legal. What about divorce? Only God is allowed to dissolve a marriage so why don't you work hard to get divorce banned? Why do you get to pick and choose the parts of the Bible you care about?

  5. Look at the bright side. With the new Lowe's call center, that means 1000 jobs at $10 bucks an hour. IMS has to be drooling over all that disposable income. If those employees can save all their extra money after bills, in five years they can go to the race LIVE. Can you say attendance boost?

ADVERTISEMENT