| February 7, 2013 | News for the food and drug law community |
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| Drugs & Biologics |  |  |
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- FDA seeks ways to reward quality
The FDA is considering developing a quality scorecard for drug manufacturers in an effort to prevent quality problems that have contributed to recent drug shortages, according to an article in Clinical Pharmacology & Therapeutics by FDA officials Janet Woodcock and Marta Wosinka. Pharmalot.com/Pharma blog
(2/6)  
- FDA issues warning against deceptive flu products
The FDA has released a report warning the public against fraudulent flu products that carry unproven claims about curing, treating or preventing the flu. The warning covers drugs, nasal sprays, devices, foods and dietary supplements. The FDA said it has yet to approve any over-the-counter treatment that can cure or prevent the condition, and there are no approved generic formulations of Tamiflu or Relenza. PhysiciansBriefing.com/HealthDay News
(2/5)
- Sequester could slow or stop FDA reviews, analyst warns
FDA operations will be limited by budget sequestration if lawmakers don't move to stop an 8.2% automatic cut before March 1, the consulting firm Avalere Health warned. "An underfunded FDA could lead to FDA review clocks being reset or delayed, which would affect a sponsor's ability to obtain product approval -- thus delaying patient access to cutting edge medical innovations," Avalere said in its report. The Hill/Healthwatch blog
(2/5)
| Global Focus | | |
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- India implements compensation rules for injury, death in studies
India's government is making compensation mandatory when clinical trial volunteers are injured or die. Failure to comply could result in a ban or suspension of trials for drug companies and clinical research organizations. Compensation will be decided by an independent committee appointed by the drug controller general of India on a case-to-case basis, according to a government official. The Economic Times (India)
(2/7)
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- FDA: Antibiotic use in animals, resistance in bacteria are up
About 2.3% more antibiotics were used in animal production in 2011 than 2010, according to a report from the FDA. A separate report found an increase in the prevalence of certain types of drug-resistant bacteria in meat. Sales of sulfas, a class of antibiotics used in humans, were down 36%, according to the report on agricultural antibiotics. Rep. Louise Slaughter, D-N.Y., said Congress should act to reduce the use of agricultural antibiotics because "the threat of antibiotic-resistant disease is real, it is growing and those most at risk are our seniors and children." FoodSafetyNews.com
(2/6), FoodSafetyNews.com
(2/7)
| Medical Devices | | |
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- Legislators introduce bill aimed at repealing device tax
A bill that would repeal the 2.3% medical device tax has been introduced by Reps. Erik Paulsen, R-Minn., and Ron Kind, D-Wis., along with more than 170 co-sponsors. The legislators said the tax could stymie economic growth and job creation in the medtech sector, which provides more than 400,000 jobs in the U.S. A companion bill is expected to follow in the Senate soon. AuntMinnie.com (free registration)
(2/6)
- J&J unit gains 510(k) clearance for surgical sealer
Ethicon, a Johnson & Johnson unit, has been cleared by the FDA to market its Enseal G2 Articulating system. The device, which is used to aid surgeons in accessing tight cavities and minimizing internal bleeding, improves on the company's original Enseal system with the ability to flex around bodily structures. MassDevice.com (Boston)
(2/6)
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| FDLI Items | | |
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2013 conference calendar announced -- speak, register & save the dates!
There are plenty of speaking opportunities available for this year's FDLI conferences. Please email our development team if you are interested in participating or have any session/program ideas. FDLI members routinely receive at least a 20% discount on FDLI conferences, webinars and publications. Upcoming programs include:
- Pharmacy Compounding: An FDLI Dialogue | Feb. 12 | Washington, D.C., or via teleconference
- Medical Device Compliance, Regulation and Litigation Conference | March 4 | Washington, D.C.
- Introduction to Drug Law and Regulation | April 3-4 | Washington, D.C.
- Introduction to Medical Device Law and Regulation | April 3-4 | Washington, D.C.
- FDLI Annual Conference | April 23-24 | Washington, D.C.
- FDLI International Conference | June 10-11 | Beijing
- Advertising & Promotion Conference | Sept. 16-17 | Washington, D.C.
- Food Advertising: Claims, Litigations and Strategies | Oct. 8 | Washington, D.C.
- FDA Regulation of Tobacco Products | Oct. 17 | Washington, D.C.
- Enforcement, Litigation and Compliance | Dec. 10-11 | Washington, D.C.
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