FDA Says Abbott DVD Featuring Magic Johnson Broke Rules
22 Luglio 2009 - 10:12PM
Dow Jones News
An Abbott Laboratories (ABT) promotional DVD in which basketball
star Earvin "Magic" Johnson touts HIV drug Kaletra was misleading
because it overstated the drug's efficacy and minimized its risks,
the U.S. drug regulator said Wednesday.
The Food and Drug Administration sent Abbott a warning letter
July 14 saying the DVD violated federal regulations that prohibit
misbranding a drug. The agency asked the Abbott Park, Ill., company
to stop disseminating the DVD, and to outline its plans to
distribute truthful promotional materials in the future.
"These violations are concerning from a public health
perspective because they suggest that Kaletra is safer and more
effective than has been demonstrated by substantial evidence or
substantial clinical experience, and encourage use in circumstances
other than those for which the drug has been shown to be safe and
effective," the FDA said in its letter to Abbott Chief Executive
Miles White.
Abbott spokeswoman Michelle Johnson said "the material that is
referenced in the FDA letter is no longer in use and we're working
with the agency to address their comments as well as the guidance
they provided within the letter."
The DVD was given to health-care professionals and AIDS advocacy
groups.
According to the FDA, the promotional DVD features an interview
with Magic Johnson, a star of the National Basketball Association
in the 1980s who was diagnosed HIV-positive in 1991.
In the interview, Johnson discusses the benefits he has
experienced from Kaletra, and briefly acknowledges fatigue as a
side effect. The FDA said the discussion and interview portion of
the DVD omits any mention of serious risks, and instead relegates
this information until the end of the DVD, "where it is unlikely to
draw the viewer's attention." The drug's serious risks include
pancreatitis, diabetes and other conditions, the FDA said.
Attempts to reach Johnson through his business, Magic Johnson
Enterprises, weren't immediately successful.
The FDA also said the DVD contained an outdated version of the
approved product labeling for Kaletra. The outdated version didn't
include important safety information regarding the use of Kaletra
in children.
Abbott submitted the video for FDA review in November 2008, and
the DVD's content was available on the Kaletra product Web site as
recently as July 10, the FDA said.
It's not the first time Abbott has gotten into trouble with its
Kaletra marketing. FDA sent Abbott a letter in 2004 expressing
concerns about a print ad and poster the FDA considered to be
misleading. "We are concerned that you are continuing to promote
your product in a similarly violative manner," the FDA wrote this
month.
Abbott recorded Kaletra sales of $635 million for the first six
months of 2009, down 10% from a year earlier.
Abbott shares fell 95 cents, or 2%, to $44.05 Wednesday.
-By Peter Loftus, Dow Jones Newswires; 215-656-8289;
peter.loftus@dowjones.com