| November 9, 2012 | News for the food and drug law community |
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| Drugs & Biologics |  |  |
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- Letters from FDA underscore heated rivalry
The FDA Office of Prescription Drug Promotion issued in October untitled letters to Cornerstone Therapeutics and ONY Pharmaceuticals for promoting their respective drugs for neonatal respiratory disease syndrome. The two drugmakers are cited by the FDA for making unsupported superiority claims and omitting risk information. The letters are a sign of what can happen when drugs are marketed at the expense of rivals, according to this article. Pharmalot.com/Pharma Blog
(11/8)  
- NEJM editorial: Ruling stood in way of FDA preventing outbreak
 If a 1997 law hadn't been overturned in 2002, it's possible the FDA would have prevented the meningitis outbreak tied to contaminated steroids from the New England Compounding Center, Boston University law professor Kevin Outterson wrote in a commentary published online in the New England Journal of Medicine. The FDA was given more authority to regulate drug compounders in 1997, but the Supreme Court overturned some provisions in Thompson v. Western States Medical, Outterson said. "Regulators need a strong mandate to protect the public health," according to an editorial published together with Outterson's commentary. Los Angeles Times/Booster Shots blog (tiered subscription model)
(11/8)
- BIO exec: Fiscal cliff threatens FDA reviews and biotech jobs
The elections did not ease concerns about the looming federal fiscal cliff, and the results could be a disaster for biotech jobs, research and the FDA's review processes, Biotechnology Industry Organization Federal Relations director Jeanne Haggerty said in a postelection review at MichBio Expo. In Michigan alone, the cost could be 31,000 jobs. A temporary deal to push cuts to the spring may be possible in the lame-duck Congress, Haggerty said. Crain's Detroit Business (free registration)
(11/7)
| Global Focus | | |
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- U.K. agency pulls endorsement for Novartis asthma drug Xolair
The U.K. National Institute for Health and Clinical Excellence is planning to withdraw its endorsement for Novartis' Xolair, or omalizumab, for severe asthma in adults. "After considering new evidence that has become available since the original guidance was published -- particularly new mortality data -- the NICE draft guidance does not recommend omalizumab for either adults or children," the agency said. Reuters
(11/9)
- Pfizer loses Canadian patent for ED drug Viagra
The Canadian Supreme Court stripped the patent for erectile dysfunction drug Viagra from Pfizer in a 7-0 verdict that backs an appeal by Teva Pharmaceutical Industries. Pfizer failed to give sufficient details to identify the treatment's active ingredient, the court said. "As a matter of policy and sound interpretation, patentees cannot be allowed to 'game' the system in this way," Justice Louis LeBel wrote. Reuters
(11/9)
| Food & Dietary Supplements | | |
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- Apple cider tied to E. coli cases in Mich.
Michigan agriculture and health officials are investigating the cases of E. coli infection that may be linked to unpasteurized apple cider. Health officials have gathered samples to find out if the bacteria from patients and the cider have similar genetic fingerprints. FoodSafetyNews.com
(11/8)
| Medical Devices | | |
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- AdvaMed recommends changes to proposed device ID rule
The proposal to create a unique device identifier system for medical technologies is the "most extensive and complex FDA regulation to be issued in recent memory" and the agency should work to "get it right the first time," AdvaMed's Janet Trunzo said. The group recommends that certain changes be made to the proposed rule, including extending from one to two years the time required for makers of Class III medical devices to adopt UDI. MedCityNews.com
(11/8)
| FDLI Items | | |
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Expanded agenda posted for Enforcement, Litigation and Compliance Conference
View the conference agenda to see the latest confirmed speakers and panel summaries for Dec. 12-13 program. Recently posted summaries with confirmed speakers include the "Enforcement Basics: Responding to FDA Enforcement Actions" session. In this session, experienced attorneys will discuss practical applications and strategies dealing with various FDA enforcement actions, including:
- Addressing Form FDA 483 inspectional observations.
- Responding to enforcement letters for promotional issues (Warning Letters and Notices of Violation) and manufacturing issues (cGMP and QSR).
- Negotiating consent decrees.
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New 3rd Edition -- Off Label: A Guide to Sales & Marketing Compliance
Do you want to make sure that your company or clients understand the complicated FDA regulations for advertising and promoting pharmaceutical products? The third edition of FDLI's best-selling Off-Label Communications: A Guide to Sales & Marketing Compliance is a comprehensive, practical guidebook on how to comply with the often changing world of off-label regulation, litigation and policy.
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