It is a three-day weekend! Granted we just had the holidays, but they are very filled with exhausting activity – decorating, receiving guests, being a guest, wrapping. We need some recover time and in the spirit of the weekend, to take stock of the ways in which we can make the world a more peaceful place. Here is a bit of what happened this week:
- A Device to Treat Obesity? FDA Approves One. FDA announced approval this week of the first-of-its kind device to treat obesity. The device – the Maestro Rechargeable System – is also the first device approved by FDA for obesity since 2007. It consists of a rechargeable electrical pulse generator, wire leads and electrodes which are implanted surgically into the abdomen and then sends electrical pulses to the abdominal vagus nerve which is involved in regulating stomach emptying and signaling to the brain that the stomach is full. The approval came despite the fact that the clinical study did not meet its original endpoint of having the treatment group lose at least 10 percent more weight than the control group.
- Drugs and Driving – FDA Draft Guidance – This week FDA issued a draft guidance “Evaluating Drug Effects on the Ability to Operate a Motor Vehicle” with the purpose of assisting drug sponsors to evaluate the effects of psychoactive drugs on the range of activities necessary to drive – cognitive and perceptual. Public comment is being opened and those interested in viewing and providing comment can do so at www.regulations.gov – when you get to the site, perform a search for the draft and the docket.
- Senator Schumer Calls for Greater Transparency and Heightened Inspection on Food Violations – The Office of Senator Charles Schumer (D-NY) announced this week that it had sent FDA a letter urging FDA to implement new steps that would address recent reports of rat-invested warehouses that supply food materials across the country to restaurants. In particular, concerns focused not only on the unsanitary conditions, but the lack of transparency that left the customers for these goods largely unaware of the violations at the time they are cited, meaning that purchases could continue while uninformed by the circumstances. Among other things, he called for a readily searchable database to better inform the environment, increased inspections and greater penalty for violations.
- A New Congress Opens Up for Business – In case you missed them, most of Congress has returned and opened up the 114th Congress, bringing with them new members and, in the case of the Senate, new leadership. Committee chairs are being occupied by new members and new legislation is already being introduced. Accordingly on the Eye on FDA Website, there is a tab – “Proposed Federal Legislation – 114th Congress” that will overview new legislation that is introduced that would have an impact on agency policy or industry practice.
That’s it for me this week. Taking Monday off and wishing you all a good, safe weekend. Peace to all.