Tag / FDA
Disturbing Discovery by FDA that Chocolate often has undeclared Milk
Since I have a son with food allergies, I was appalled by this story that FDA has determined that chocolate often has undeclared milk. Click the link below to the full story for more information.
What FDA Learned About Dark Chocolate and Milk Allergies
Note: This Consumer Update sheds further light on the results of an FDA study on milk in dark chocolate shared in an earlier story. For more detail, read the study results.
If you’re allergic to milk and you love dark chocolate, how do you know whether you can indulge in a candy bar without having an allergic reaction? That’s what the Food and Drug Administration (FDA) wanted to learn, especially after receiving reports that consumers had harmful reactions after eating dark chocolate.
FDA FY 2010 Inspectional Observation Summaries
The FDA has recently updated their published 483 inspection results here. This is really a great resource as it breaks the findings down by regulation and how often it was cited. The link is to the 2010 483 that I stumbled upon. The parent site has multiple years and in sortable formats:
21 CFR part 11 Update
Folks, it looks like some of our US regulations and guidance documents have been flagged for update by FDA….including everyone’s favorite, 21 CFR part 11 (source Cerulean’s email newsletter). I don’t anticipate major changes, just clarification on their intent. Everyone enjoy your Friday.
New Guidance Agenda for 2009 Released by FDA
The FDA’s CDER has published its list of expected guidance documents and revised regulations to be issued this year (2009).
Readers of our 2009 forecast will find many items on the list familiar:
· Adaptive Clinical Trial Design
· Various marketing, promotional and labeling guidance
Ignorance on the Placebo Effect
I was reading some blog posts over at Wellsphere when I saw the following thoughts on the placebo effect from Seth Roberts
What Should Double-Blind Placebo-Controlled Trials Be Replaced With?
For a sick person, which is worse?
1. Getting better for the wrong reason.
2. Wasting a lot of money.
It sounds like a joke — #1 isn’t even harmful, whereas the cost of health care is a very serious problem. Yet the FDA and legislators with FDA oversight have been given this choice — and chosen #1. They have chosen to protect us against #1 but not #2.
If you get better from a placebo effect, that’s the wrong reason. How dare you! The requirement that drugs be better than placebo controls prevents this from happening. The requirement might have been — but isn’t — that a new drug be better than pre-existing alternatives. Many aren’t but they are always more expensive — not to mention more risky.
Now Seth has a Ph.D. in psychology, blogs on science-related topics, and seems like a smart enough guy, but his post is a bit misguided.
1) The reason that drugs are required to perform better than a placebo is because the placebo effect tends to only occur in a small set of patients. That is that the mental makeup of a specific patient is the cause of a placebo response (irregardless of the treatment). It is also not clear whether a placebo respondee is “actually getting better”. It is just as likely that they were not actually sick in the first place (or as sick as they thought).
2) Those patients who are not predisposed toward exhibiting placebo responses need to be given an actual effective treatment to “get better” and therefore deserve medications that exhibit “better than placebo” characteristics. Giving such a sick patient a sham treatment (rather than one that can actually work) can be very harmful in that the person’s condition can actually worsen.
3) There is a requirement from FDA (and regulatory agencies worldwide) that new drugs be as good or better than existing medications; or that they provide some sort of unique benefit (or reduced risk).
4) The expense of new medications is largely due to the high cost of research to make those medications (and fund future research). The low-hanging fruit is largely gone.
Roles for QA
I was scanning through my email subscriptions today and noted an interesting item in my FDA News Drug Daily Bulletin (from the company “FDA News”) advertising one of their publications. Now, most of the time these “industry best practice” white papers are information that is common-sensical or freely available from another source (e.g., compilations of FDA Warning Letters that are available on the www.fda.gov website) so I typically ignore them. However, the tone and posturing of this one caught my eye:
Lower Your Site Risk Potential (SRP) Score
Lower Your Site Risk Potential (SRP) Score zeroes in on what this risk-ranking model is and how FDA is using it to classify manufacturing plants and prioritize enforcement. This new management report also goes a vital extra step, showing you how to implement practical strategies that can reduce your score, limit inspections and unlock a host of valuable new business benefits.
To order, go to http://www.fdanews.com/store/product/detail?productId=23141.
To me, that is marketing to the worst of us. It doesn’t offer help to actually improve one’s processes, systems, or products so as to have more successful inspections. It implies that by doing certain things, a manufacturer can place themselves “below FDA’s radar” and thereby reduce the number of inspections to which one is subject. That is not to say that the advertisement is selling a lousy or unethical document. I wouldn’t know since I haven’t read it.
The ad did get me thinking about the various roles I play as a QA Auditor though. I was born an optimist, but through my work in QA, I’ve become somewhat of a reluctant realist. There are always those who will seek out “the quick and easy path” rather than the high road. That being said, my role varies depending upon with what I’m dealing:
1) In my opinion, most people I meet and with whom I’ve worked are genuinely interested in doing a good job, the right thing, etc.; and for that I am thankful. And as a QA professional, my primary job is to help them do just that. By serving as a fresh pair of eyes, as an uninvolved outsider, I can help those who may be by necessity focused on the trees, see the forest. This is the role I like best, that of an internal consultant.
2) In other instances, there are those who are very ready to make what a former mentor of mine liked to call “overly pragmatic decisions”. For situations like this, my role tends to be more akin to that of a traffic cop. Almost everybody slows down when they see a parked patrol car. My presence lets people know that “someone is looking”.
3) In the worst cases, I’m there to catch the most aggregious offenders, those who totally disregard ethical or moral considerations; or who are just so sloppy in their practice that they pose a major risk to their subjects, the public, or the research itself. I play the role of the enforcer in these cases. I like this role the least. However, I try to remember that it is because of this minority situation that there will always be a role for Quality Assurance.