Update on Recent OPDP Letters and FDA Bad 2012
21
Alan Bergstrom Senior Director, Commercial Regulatory Affairs CBI 14 th Annual Forum on Off-Label Guidelines October 11, 2012 Update on OPDP Letters, Off- Label Settlements, and FDA Bad Ad Program
-
Upload
alan-bergstrom -
Category
Documents
-
view
27 -
download
2
Transcript of Update on Recent OPDP Letters and FDA Bad 2012
Alan BergstromSenior Director, Commercial Regulatory Affairs
CBI 14th Annual Forum on Off-Label GuidelinesOctober 11, 2012
Update on OPDP Letters, Off-Label Settlements, and FDA Bad Ad Program
The content, views, and opinions in this presentation are my own and do not in anyway represent the views or opinions of Daiichi Sankyo, Inc.
3
What is Off-Label Information
•HCPs can lawfully use or prescribe products for uses or indications not described in approved labeling.
•FDCA and regulations prohibit a manufacturer from introducing new drugs or devices into interstate commerce for a use that FDA has not determined to be safe and effective
•Statements that promote a drug or device for uses other than those approved by FDA may be used as evidence of a new use.
•Introducing a product into commerce for such a new intended use would generally violate the law.
4
Recent OPDP Letters re Off-label use
•In 2010, 48 Untitled Letters or Warning Letters were issued. 3 were for unapproved uses. 2 of these were Warning Letters.
•In 2011, 31 letters total, of which 3 were unapproved uses.
•Through August 2012, 20 letters total, 2 for unapproved uses
5
Recent OPDP Letters re Off-label use
•Amgen 5/24/2010 - oral statements at ASHP that VECTIBIX is a first-line therapy which is an unapproved use
•Forest 4/28/2011 - oral statements by a sales rep that SAVELLA is approved for fibromyalgia and useful in back pain and mood disorder
•Ortho-McNeil, Janssen 8/26/2011- Oral statements at ASHP that NUCYNTA is effective in Diabetic Peripheral Neuropathic Pain
•Sunovion 12/14/2011-Oral statements to an HCP about ongoing studies for use of LATUDA in bipolar disorder
Oral Statements by Sales Reps
6
Recent OPDP Letters re Off-label use
•Merck 2/28/2012-oral statements by a physician speaker at promotional event suggesting SAPHRIS was safe and effective for an unapproved use
Oral Statements by Speaker
7
Recent OPDP Letters re Off-label use
•Slate Pharmaceuticals WARNING Letter 3/24/2010 - website and consumer video for TESTOPEL which promoted treatments for depression, ED, T2DM, mood disorders, loss of sexual interest, and for increased muscle mass and bone strength
•Novartis WARNING Letter 4/21/2010 – website which promoted Gleevec for neoadjuvant therapy prior to surgery
Websites and Consumer Video
8
9
10
11
12
13
Recent OPDP Letters re Off-label use
•Ferring 3/30/2012- sales aid for FIRMAGON suggests an unapproved new use as neoadjuvant use prior to radiation or to treat rising PSA levels
Sales Aid
14
15
Off-Label Settlements
•Ortho-McNeil Pharm. LLP and Ortho-McNeil Jansen - TOPAMAX - $81.5M•AstraZeneca LLP and AstraZeneca Pharm. LP – SEROQUEL $520M•Novartis Vaccines - TOBI $72.5M•Eisai – ZONEGRAN $11M•Allergan – BOTOX $600M•Forest - CELEXA, LEXAPRO $313M•Novartis – TRILEPTAL $185M•Kos Phar – NIASPAN, ADVICOR $51.4M•Elan Corp ZONEGRAN $214.5M
•Total $2,048M
2010
16
Off-Label Settlements
•Merck – VIOXX $950M•NovoNordisk – NovoSeven $25M•Pfizer – DETROL $14.5M•Scios – NATRECOR $85M•UCB – KEPPRA $35M
•Total $1,109M
2011
17
Off-Label Settlements
Total for 2010 and 2011 was $3.157 Billion
18
Notable Off-Label Settlements
•Settled for $321 million (criminal) and $628 million (civil) involving off-label promotion of VIOXX
• DoJ press release announcing the settlement specifically refers to Warning Letter issued in Sept 2001
•Promotional audio conferences June 2000 in which VIOXX was promoted for unapproved uses and unapproved dosing regimens.
• …effective in terms of treating patients with rheumatoid arthritis.• …safe and effective for …prevention of cancer and invasive cancer, and for the
treatment • …COX-2 seems to be able to interfere with programmed cell death. Therefore
you get this increased cell growth which allows polyps to form, cancer and then invasive cancer. And by blocking COX-2 you can actually prevent the development of colon polyps, cancer and invasive cancer.
• …within one or two pills acute attacks of gout were being shut down.• …potential uses of these drugs, the most exciting right now I guess in two areas,
one is Alzheimer’s disease…
Merck 12/16/2011
19
Notable Off-Label Settlements
•Abbott – $1.5 billion for the off-label promotion of DEPAKOTE for agitation, aggression in elderly dementia patients, and schizphrenia
•GSK – $3 billion for the off-label promotion of PAXIL for treating depression in patients under 18 and WELLBUTRIN for weight loss, sexual dysfunction, substance addictions and ADHD
•These two settlements exceed the $3.157 billion collected in 2010 and 2011.
2012
20
Bad Ad Program
Initial kick-off May 2010Letter to 33,000 HCPs, PR, informational video, Bad Ad brochure, exhibits at 15 medical conferences, Bad Ad webinarIn the first year, received 328 reports of potentially untruthful or misleading promotions (188 from HCPs, 116 by consumers, 24 from pharma)Issued 5 lettersFor 2011-2012 – continued to raise awareness through CE program, case studies and Bad Ad journal ad Issued 3 lettersFor the future, will continue CE programs, continue liaison with healthcare organizations, and pursue additional opportunities with medical, pharmacy, and nursing schools to enhance education.
21
Thank You.
Questions?
