Each quarter I regularly try to provide a little insight into OPDP’s current thinking as expressed through the issuance of Warning and NOV letters. What we saw last year is that the number of such letters after rising a bit in 2009 and 2010 in number, slumped again in 2012.
But that is nothing compared to the first quarter of 2013, where we saw a total of 3, count ‘em 3, letters issued from OPDP to industry. Despite the fact that this quarter provides slim pickings, we persevere.
From this quarter, the three letters involved only three communications vehicles, none of which were digital properties (two were brochures) and none of which were Warning Letters and none of which involved drugs with boxed warnings.
The category for most common violation is usually Risk Minimization and while that did get the most this quarter, it tied with Superiority Claims at 3 and 3. Also included in this quarter was one instance of Overstatement of Efficacy, one Unsubstantiated Claim and one Inadequate Communication of Indication, making a total of 9 violations for the quarter, or 3 per letter.
Will keep you posted on next quarter some time in July.
It has been a really busy week with travel and work that last Friday I didn’t even get to the Weekly Roundup. The schedule has been so busy, leaving no spare time for either posting here on the blog or continuing to clear away the dead growth in the garden. We have had a few minutes of Spring that already seem tempted to ebb into humid muggy days that we should not get till Summer.
But here is a bit of what I saw that happened when I came up for air:
That’s it for me this week. I hope everyone has a good and safe weekend.
The daffodils are up and being rounded up in bunches and slipped into vases around the house, spreading good cheer, but overall Spring is still seemingly quite shy though indications are that is about to change. It is perhaps a good time to give the grill on the BBQ pit a good scraping for the coming season. It has been a mostly quiet week at FDA – perhaps everyone went away for a Spring Break! As of publication time, there were no press releases from the agency this week, now OPDP warning letters posted…. all quiet.
In the meantime, there were some interesting things:
- Judge Rules Plan B Should Go OTC for All Ages – In a new chapter of a very long story of “morning after” contraception, a federal judge has reversed a reversal of a decision regarding the availability of an over-the-counter application for Plan B. In 2011, FDA was poised to approve the OTC application but that decision was historically ordered reversed by the intervention of HHS. Today that reversal was reversed by a federal judge and ordered FDA to approve the OTC application. Will this close the book on the subject?
- H.R.1150 – Preservation of Antibiotics for Medical Treatment Act - The legislative developments are pretty much appearing here whenever I catch them. This bill was introduced in the House by Congresswoman Louise Slaughter (D-NY-25) with the purpose of addressing emerging antibiotic resistance as a result of use of medically important antibiotics to a food-producing animal for non-routine disease control.
- FDA Commissioner Hamburg Speaks Out on Painkillers – In a blog posting on the FDA blog FDAVoice entitled “When Pain Relievers Cause Pain, Society Must Act“, Commissioner Margaret Hamburg addressed the abuse of opioids in the U.S. Stating that in “2010, an estimated 16,651 peopled (sic) died because of inappropriate use of prescription opioid drugs, a 313 percent increase over the past decade”, she outlined FDA’s approach which involved a blend of continuing research about pain, discovery of abuse-deterrent formulations, more accurate labeling, increased education, mandatory training programs for prescribers, new packaging and improving availability of new products that can treat abuse and overdose. On that same day, Senate Minority Leader Mitch McConnell sent a letter to FDA urging the agency to consider ways to ensure that tamper-resistant efforts taken by brand name pain killers are also in use by generics that come to market.
That’s it for me this week folks. I hope you all have wonderful weekends and see you next week, when surely Spring will have grown more emboldened.