My data base on warning and untitled letters now includes the years 2004-today. It includes 282 letters covering a neat total of 1000 different violations. When I was working on it earlier, I did a post looking at letters aimed at products with boxed warnings and thought it a good time to revisit the topic now that there is more information in the data base.
Common sense might tell one that if a product has a boxed warning – and therefore there are specific safety issues that FDA wants to highlight, then regulatory action letters from the Office of Prescription Drug Promotion (OPDP) might more often come in the more serious form – Warning Letters – as opposed to Untitled Letters (a/k/a Notice of Violation). It appeared true in 2012.
What is the ratio of Warning versus Untitled Letters? Of the 282 letters, 34 percent (96) were Warning Letters between 2004 and the present. And of the 282 letters, only 14 percent (40) involved a product with with a Boxed Warning while 86 percent (242) did not have Boxed Warnings. However, of the 40 Boxed Warning Letters, 45 percent of them were Warning Letters while of the 242 regular labels, only 32 percent were Warning Letters.
Therefore it stands to reason that when you are dealing with a product with a Boxed Warning in its label, extra care needs to be taken with regard to communications because if there is a violation, it would appear that there is a greater tendency for it to be in the form of a more serious Warning Letter than Untitled Letter.
Oh dear. I originally dated this Weekly Roundup as being in 2011. That is the kind of week it has been – I’m not even sure what year it is. The time of year, however, is obvious, with multi-tinted leaves fluttering in sunlight, shorter days, and cooler temperatures and we all are thinking about Thanksgiving recipes. Well, I am, anyway, even if in 2011.
Meanwhile, here is a bit of what happened this week:
- Trans Fats Action by FDA – FDA announced yesterday that it was taking action in relation to foods containing Trans Fats. Noting that if industrially produced trans fat were eliminated from foots, it might be possible to prevent 20,000 heart attacks and 7000 heart-related deaths each year, FDA announced its “preliminary determination” that partially hydrogenated oils (PHOs) are no longer to be considered”generally recognized as safe” for use in foods. The agency said that it opened up a 60-day comment period to collect input regarding the GRAS status pre-determination. Over the past few decades, consumption of PHOs has diminished considerably, it still exists in many prepared foods. If, ultimately, it is determined that PHOs should no longer be used in foods, FDA said that it will give a timeline for industry to comply. The agency issued a press release on the topic as well as a blog posting on its blog FDA Voice. The agency also took the unusual step of sending out an email to a list asking that the information be tweeted, however, by that time, the news had already saturated Twitter.
- New Guidance on Devices - FDA announced availability of a new guidance entitled “Design Considerations for Pivotal Clinical Investigations for Medical Devices” which is meant to offer guidance for the design of clinical studies intended to support new premarket submissions. It describes different study design principles for medical device studies.
- FDA Seeking Comment on New Generic Rule on Information Updates – FDA announced today that it would be seeking public comment on a rule that would allow generic drug makers to use the same process as brand drug manufacturers to update safety information in the product labeling. ”Under the proposal, generic drug manufacturers would be able to independently update product labeling (also called prescribing information or package inserts) with newly-acquired safety information before the FDA’s review of the change, in the same way brand drug manufacturers do today.” In addition, generic manufacturers would have to inform the brand name manufacturer about the change. Full information and background is available in the Federal Register posting on the topic.
That’s it for me this week folks. Have a wonderful and restful weekend.
We are in the last two months of 2013. Because in my head it is still 1997, I find this hard to wrap my head around. But not even a government shut down makes time stand still. It is November 1 – long shadows are cast in the mid-afternoons and after this week, what will be do with a day shorter of daylight? Today, there are a lot of kids all hopped up on sugar out there. A lot of us left holding candy that didn’t get handed out. What happens to that every year? So many questions….
And if you have questions about what happened this week, here are at least a few things:
- FDA Announces Steps to Curb Drug Shortages – You may recall a few years back when the subject of drug shortages for critical drugs were in short supply, prompting an Executive Order from President Obama in 2011. This week FDA announced two actions that the agency was taking to address drug shortages. The first is a strategic plan which was called for in the Food andDrug Administration Safety and Innovation Act (FDASIA) passed in 2012. According to the release, the plan is to work with manufacturers to promote sustained quality manufacturing. The second action involved the issuance of a proposed rule that requires manufacturers to notify the agency of any permanent discontinuance, which was also part of the Executive Order. There is a separate docket that has been established for the public to provide comment on the proposed rule that will apparently be open next week.
- Not Very Good News About Spices - The Center for Food Safety and Nutrition (CFSAN) released a constituent update regarding the development of a draft risk profile on pathogens and filth in spices. This risk profile was put together in the wake of recent outbreaks of human illness from Salmonella contaminated spices and suggests new mitigation and control options. The study identified 14 outbreaks worldwide that were associated with spices occurring from 1973-2010. You can read a copy of the report here and apparently provide commentary next week here.
- FDA’s Role in Personalized Medicine – Sometimes I come across something on FDA’s site that is new to me, but I’m not sure whether it is really new or not since the agency typically does not date material, which is unfortunate. However, what they do tag on is a notice about when the page was last updated. Here is a handy overview of how the agency perceives its role in the developing world of personalized medicine, and the page was last updated 10/29/13 – so even if, unlike me, you are already familiar with this page, there is at least something new on it.
That’s it for me this week everyone. I hope you manage ok with your leftover candy. And for those of you in the northern hemisphere, have a lovely autumn weekend.
Photo by Anne Becker