FDA accuses Novartis of misrepresenting Tasigna, et al

[Guest guest]

This website contains a " Facebook Share " social media widget that generates

Novartis-created information for Tasigna that can be shared with Facebook users

(i.e., " shared content " ).

The shared content is misleading because it makes representations about the

efficacy of Tasigna but fails to communicate any risk information associated

with the use of this drug.

In addition, the shared content inadequately communicates Tasigna's

FDA-approved indication and implies superiority over other products. Thus, the

shared content for Tasigna misbrands the drug in violation of the Federal Food,

Drug, and Cosmetic Act (the Act) and FDA implementing regulations. See 21 U.S.C.

352(a) & (n), 321(n); 21 CFR 202.1(e)(3)(i), (ii) & (e)(6)(i). Furthermore,

these materials were neither submitted to FDA 30 days prior to the intended time

of initial dissemination or initial publication as required by 21 CFR 314.550,

nor submitted to FDA on Form FDA 2253 at the time of initial dissemination or

initial publication, as required by 21 CFR 314.81((3)(i). (Article Date: 08

Aug 2010)

The FDA asks Novartis to stop disseminating " violative promotional material "

for Tasigna, such as those quoted in the letter. Novartis is also asked to

respond in writing before August 12, 2010, stating whether the company intends

to comply with this request.

The letter was written by: R. Rulli, Ph.D., Acting Group Leader,

Division of Drug Marketing, Advertising, and Communications (DDMAC), FDA.

Written by: Christian Nordqvist

http://www.medicalnewstoday.com/articles/197209.php

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Important findings from the CAS report include:

-- During the last 20 years, cancer therapy journal publications grew 179

percent, while patent publications grew 318 percent.

-- From 1990 to 2009, journal article publications about CML treatment

expanded 196 percent. At the same time, patent publications exploded with 700

percent growth.

-- The World Intellectual Patent Organization (WIPO) is the leading patent

authority for Gleevec use in CML.

-- U.S. researchers authored three times as many journal publications for

Gleevec as any other country.

-- In 2009, second-generation drugs Tasigna and Sprycel displaced Gleevec as

single medications for CML, with a combined 41-fold increase in journal

publications and a concomitant increase in patent publications compared to

Gleevec. " The results of the analysis outlined in the CAS Chemistry Research

Report further validate that we are on the right course, " said Dr. Druker,

Director, Oregon Health & Science University Knight Cancer Institute. " The

accelerated growth in CML-related publications following Gleevec provides yet

more evidence that the targeting approach opened up new paths of exploration for

the medical and scientific communities. Based on this success we are now

optimistic that all cancers could be controlled with drugs like Gleevec. "

http://www.medicalnewstoday.com/articles/198800.php

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August 26, 2010.

An effort to streamline the entangled field of Medicare drug plans could mean

as many as 3 million seniors " could force 3 million seniors to switch plans next

year whether they like it or not, says an independent analysis, " by Avalere

Health: " beneficiaries will see their prescription plan eliminated as part of a

new effort by Medicare to winnow down duplicative coverage and offer consumers

more meaningful choices. Seniors would not lose coverage, but they could see

changes in their premiums and copayments. "

" For example, Medicare has already notified insurers they will no longer be

able to offer more than one 'basic' drug plan in any given location. " Medicare

officials dismissed the estimate as simple " guessing " (Alonso-Zaldivar, 8/25).

http://www.medicalnewstoday.com/articles/199014.php (more at website)

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FYI,

Lottie Duthu