Ok. I keep thinking summer is going to be the time when things slow down and I have a little more time for posting. I’m not teaching over the summer, people are on vacation, life slows down, right? Not so much. Hopefully next week I will have a little more time for posting – I certainly have some good stuff I’m mulling around in my head, if I can just get it onto the blog.
In the meantime, here is a bit of what happened this week:
- FDA Permits Marketing of First Brain Wave Test to Assess for ADHD – Certainly an interesting development here – the agency announced the approval for marketing of the first medical device to use brain waves as part of the assessment of attention-deficit/hyperactivity in children. The device is to be used as part of a complete medical and psychological evaluation. It is called the Neuropsychiatric EEG-Based Assessment Aid (NEBA) and is a 15-20 minute non-invasive test that works by calculating the ratio of two brain wave frequencies.
- Dr. Woodcock Again Addresses Regulation of Compounding – It was only in May that Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) offered testimony before the House Subcommittee on Health, Committee on Energy and Commerce entitled “Examining Drug Compounding“. She returned for a sequel this week when she offered another statement before the committee “Reforming the Drug Compounding Regulatory Framework“. She set forth a framework that would recognize the two types of compounding – traditional and non-traditional (customizing an existing medication to suit a particular patient versus compounding a drug to meet a specific medical need). She acknowledged that some products should not be compounded under any circumstances. She stated that the agency should have the clear authority to collect and test samples of compounded drugs and collect pharmacy records and that there should be an accurate inventory of pharmacies engaged in non-traditional compounding – all of which might be supported through a user-fee type program. Her testimonies, along with other compounding links are all housed on the Eye on FDA Compounding Tab on the blog site.
- Congressional Update on Legislation – This was not introduced this week, but recently and has been added to the Proposed Federal Legislation – 113th Congress tab on the blog, where you can find several pieces of legislation that would impact FDA and/or industry. First is H.R.2315 – Preserving Access to Orphan Drugs Act of 2013, introduced by Rep. Jim Gerlach, which would amend the Affordable Care Act (ACA) which would exclude orphan drugs from the annual fee due from manufacturers with sales exceeding $5 million. The companion bill in the Senate is S.1128 and was introduced by Senator Pat Toomey.
That’s it for me after this long, hot week. A cool front is coming through and I look forward to it. Have a good weekend everyone.
