I miss doing the Weekly Roundup and so I am bringing it back. Part of the reason that it subsided is that I have been working hard on a rather large project that is now concluded, so let’s round up the news again once a week. Here goes.
- Senator Franken Introduces the FAIR Generics Act – The Fair and Immediate Release of Generic Drugs Act was introduced in the Senate and would revise the definition of “first applicant” for purposes of the 180-day exclusivity period for ANDA filings. Eligibility for exclusivity would hinge on whether or not the applicant has entered into a disqualifying agreement. The bill has 6 sponsors from both parties. The bill has been added to the Eye on FDA tab for Proposed Legislation. (Note, this occurred earlier in March, but only caught my eye this week….)
- Risk Communications in a Crowded World – Something I picked up from the advance Federal Register which seemed to garner a lot of interest when tweeted is the fact that FDA’s Risk Communications Advisory Committee is scheduling a meeting for April 29 and 30 at the White Oak Campus with the interesting agenda to “discuss general factors in risk communication about FDA-regulated products, including how to communicate effectively about FDA’s adverse event reporting systems, and messaging in the context of competing communicators.” FDA has been so slow to grapple with the brave new dimensions of communications, it should be an interesting meeting.
- New Alerts Involving a Recall of Product Over Sterility Confidence – On March 21, FDA issued a new alert to providers and patients about a nationwide voluntary recall of all lots of sterile products that were produced and distributed by a single company in Georgia. The expanded recall came after reports of five patients diagnosed with serious eye infections. Earlier in the week, FDA announced a separate voluntary recall regarding a separate set of products from a New Jersey company.
- FDA Approves New Magnetic Resonance Imaging Agent – The agency approved a new magnetic resonance imaging (MRI) product for use in imaging the brain, spine and associated tissues of patients aged 2 and older. According to the release from FDA, the product – Dotarem “helped radiologists better see CNS lesions” and “helped the radiologists identify lesion borders and other lesion features.” The product will carry a boxed warning about the risk of nephrogenic system fibrosis – a rare but serious condition associated with the use of gadolinium-based contrast agents such as Dotarem. Side effects, which were uncommon in clinical trials, included nausea, headache, pain or coldness at the injection site, and burning sensation. It is the seventh GBCA approved by FDA for patients undergoing CNS MRI.
That’s it for me this week. Have a good weekend folks!