This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

FDA Slaps Aegerion CEO For 'Serious' Violations of Drug Promotion Law

AEGR Chart AEGR data by YCharts

The FDA scolded Aegerion Pharmaceuticals (AEGR - Get Report) CEO Marc Beer in a sharply worded warning letter Friday for making exaggerated and unsubstantiated claims about the benefits of the company's cholesterol-lowering drug Juxtapid during two separate appearances on CNBC.

Beer's on-air statements about Juxtapid provided evidence that Aegerion was marketing the drug for unapproved uses -- a "serious" violation of FDA law, regulators said.

During interviews on CNBC's "Fast Money" program, Beer suggesting treatment with Juxtapid prevents heart attacks and extends the lives of patients with familial homozygous hyercholesterolemia (HoFH), a rare genetic disease which causes the build up of extremely high levels of cholesterol in the blood.

The FDA approved Juxtapid based on clinical trials showing the pill lowers cholesterol levels in HoFH patients only. The studies did not prove Juxtapid reduces the risk of heart attacks or helps HoFH patients live longer.

One year of Juxtapid therapy costs $250,000. At an investor meeting last week, Beer said the company was "on track to have the most successful launch in the orphan industry" and that Juxtapid peak sales could exceed $1 billion. Juxtapid competes with another HoFH drug, Kynamro, marketed by Isis Pharmaceuticals (ISIS) and the Genzyme unit of Sanofi (SNY - Get Report).

Aegerion has long maintained that the number of patients with HoFH is greater than experts have previously estimated. Not everyone agrees and some question whether Aegerion is marketing Juxtapid to patients who do not have HoFH even if their cholesterol is dangerously high.

It's not uncommon for FDA to call out drug companies for taking liberties with marketing materials, but the agency, in its letter, sounded particularly peeved at Beer's mis-statements about Juxtapid.
OPDP [FDA's Office of Prescription Drug Promotion] requests that Aegerion immediately cease misbranding Juxtapid and introducing it into interstate commerce for unapproved uses for which it lacks adequate directions. Please submit a written response to this letter on or before November 22, 2013, stating whether you intend to comply with this request, listing any promotional materials (with the 2253 submission date) for Juxtapid that contain statements such as those described above, and explaining your plan for discontinuing use of such materials or, in the alternative, your plan to cease distribution of Juxtapid. Because the violations described above are serious, we request, further, that your submission include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to correct any misimpressions about the approved use of Juxtapid.

In response to the FDA's warning letter, Aegerion issued the following statement:

We take regulatory compliance very seriously and acknowledge that our messaging in any setting, including a media interview as in this particular instance, needs to be accurate and fair balanced. Our plan is to take quick action in response to the FDA's letter and immediately and effectively address any unsuitable language. We appreciate that the FDA's objective is to ensure that promotion is consistent with approved labeling, and in that respect we are aligned with the agency.

Beer appeared on CNBC June 5 and said about Juxtapid: "It's a devastating disease that causes early death. And the drug is corrective against that disease and that's the most important thing. If you think about some oncology products that may lengthen life three months or six months, this product has the potential of taking a patient that would die at 30 and allow them to meet their grandkids."
1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AEGR $2.79 -2.11%
ISIS $40.40 -1.39%
SNY $41.46 0.88%
AAPL $93.64 -0.11%
FB $118.57 0.84%


Chart of I:DJI
DOW 17,891.16 +117.52 0.66%
S&P 500 2,081.43 +16.13 0.78%
NASDAQ 4,817.5940 +42.2360 0.88%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs