May 15, 2012
Another quarter has zoomed by. And with it, FDA’s Office of Prescription Drug Promotion (OPDP), formerly known as the Division of Drug Marketing, Advertising and Communications (DDMAC), has issued a stream of regulatory action letters known as Notice of Violation (NOV) letters or Warning Letters (WL). And on a quarterly basis, we take a look to see what regulatory wires were tripped.
In the last quarter of 2011, the pace at OPDM had picked up a bit having issued 9 letters. However, over time, the pace seems to have slowed a bit from year to year. And during the first quarter of 2012 there were a total of 6 letters issued, 1 WL and 5 NOV letters.
The 6 letters contained 18 violations by my count. One of the most notable things from this quarter however was in the frequency of some violations and lack of others. The minimization or omission of risk information has almost invariably been by far the most frequent violation cited in regulatory action letters. One of the less common violations is the promotion of an unapproved use.
However, this quarter there were only two Minimization or Omission of Risk violations noted, but there were two also for unapproved use promotion. Here is the complete breakdown:
- Overstatement of Efficacy – 6
- Unsubstantiated Claims – 5
- Promotion of Unapproved Use – 2
- Omission or Risk Minimization – 2
- Omission of Material Facts – 2
- Broadening of Indication – 1
The vehicles that carried the communications involved 3 traditional print items, 2 digital (Websites) and 1 oral statement made by a presenter.
With the frequency of violations this quarter in overstatement of efficacy and unsubstantiated claims, it appeared that a common pitfall was the description of patient experiences that, while they may have been accurate, went beyond what the typical patient experience might be or went beyond what was reflected in the label.
May 4, 2012
Wondering by the end of the day how many people will post “May the 4th be with you” on Facebook. So far I am in double digits….
We are in May. Hard to believe. I am thinking that there are many signs of a long, hot summer. Just what we need in an election year.
In the meantime, here are a few things that happened this week:
- CMS Announces Delay in Sunshine Act Reporting – You may remember that CMS already missed one important deadline for implementing the provisions of the Sunshine Act in October 2011 for publishing a proposed rule which CMS eventually did do in December. Recall also that recently Senators Charles Grassley and Herbert Kohl sent a letter to CMS expressing their desire that the agency issue a final rule no later than June 2012 on the collection of data, but that is not happening. In a blog post on May 3, CMS let it be known that they received over 300 comments on the proposed rule during the comment period. Saying they would issue a final rule “later this year” CMS also stated that data collection would not begin before January 2013.
- FDA Approves Gaucher Disease Drug – The agency announced this week that it was approving a new orphan drug Elelyso (taliglucerase alfa) – a long-term enzyme replacement therapy for treatment of Gaucher disease. Gaucher disease affects about 6000 people in the U.S. and causes a build up of fatty materials in various organs. The drug is manufactured by Pfizer.
- Facebook Pushes Organ Donation – Apparently there is ”Like” button for almost everything – after an initiative that allows folks on Facebook to opt into organ donations, several states saw a spike in willing donors. When you think about it, Facebook does have lots more people in their ranks than the Department of Motor Vehicles.
- The i’s Have It – i-Phone App Approved for Blood Glucose Monitoring – As many regular readers may know, I have a device that hooks up to my i-Pad to take my blood pressure. Well now diabetics have i-support as well with the approval of the new Sanofi US blood glucose monitoring system. It is the first FDA cleared blood glucose meter to directly connect with an iPhone or iPod touch. Check out the multi-media news release for photos, video and more.
That’s it for me this week. Have a good one everybody.
May 3, 2012
On April 30, 2012 the GAO released a report entitled “FDA Has Met Most Performance Goals for Reviewing Applications” where the title pretty much sums it up. FDA has been doing well in terms of meeting goals related to the approval of new prescription drugs. Ed Silverman at Pharmalot supplied a very nice overview of the findings and I leave it to his more capable hands on reporting both the report and some of the circumstances surrounding it.
However, one of the collateral benefits of such a report is that in reading it, one gets a good deal of context for understanding how things work. FDA is a huge agency and there is a tremendous amount of nuance to the various parts of its operations. There are many printed materials scattered throughout the Web site that often explain policies and procedures, and there are helpful statistics, but they are not often found in one spot. By reading this report, one gets some insights without having to perform the search - a true treasure trove of information.
For example:
- User fees have become a larger part of FDA’s funding for drugs – rising from 26.1 percent of costs in FY 1993 to 61.5 percent in FY 2010;
- The fee for the review of an application (NDA or BLA) that requires clinical data is $1,841,500 and half that if it does not require clinical data in FY 2012;
- A sponsor does not need to request priority review, FDA assesses all applications for priority review eligibility and if it is granted, the sponsor is notified within 60 days of the start of the review period;
- FDA convenes an advisory committee meeting for all applications for NMEs and original BLAs unless an adequate justification is documented explaining the decision not to hold a meeting (though the details of where one finds this were not included…);
- If a sponsor gets a Complete Response Letter (CRL) and resubmits, the review of the resubmission is covered under the user fee paid with the original submission and is either a Class 1 or Class 2 resubmission;
- A Class 1 resubmission contain only certain information such as draft or final printed labeling, safety or stability updates, or other minor clarifying information;
- FDA may consider a sponsor’s failure to take action within a year after the issuance of a CRL to be a request to withdraw unless an extension has been requested in writing.
Those are a few of the interesting factoids picked up by reading the report. Of course, if you read the report, you also get the download of the main subject matter – how well FDA is doing on approval times – which is “pretty good.”
May 1, 2012
The issue of drug shortages has surfaced periodically in the news and in policy circles for months, prompting both FDA and the Administration to various actions.
For some, it may be an abstract notion – the idea that some drugs may be in short supply. For patients, however, who may face the hard reality of those shortages and for the physicians who treat them, it is far from abstract.
Late in 2011, the IMS Institute for Health Informatics decided to take a look at the issue through a lens of their own making to see if the problem could be better defined. Through its extensive collection of prescription data, IMS can analyze a wealth of information to provide important insights into our consumption and use of medications in the U.S., and compiling it into a report.
The resulting report was entitled “Drug Shortages: A Closer Look at Products, Suppliers and Volume Volatility” and what it found was that the drug shortage problem is very concentrated among certain types of drugs – generics and injectables. Late last week, I had the opportunity to ask Murray Aitken, Executive Director of the IMS Institute for Healthcare Informatics, what made the IMS outlook unique, about the key findings, and what could help not only in the early detection of drug shortages, but in their prevention in the first place.
Here is the podcast of our discussion where I asked what unique ability IMS brought to the table in assessing the situation and what insights resulted.
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See also FDA’s Web page on Drug Shortages
April 30, 2012
10 Count ‘em 10.
That is how many Warning Letters the agency sent out last Friday to manufacturers and distributors of dietary supplements. The specific focus of the letters was products that were being marketed containing dimethylamylamine, also known as DMAA, sold as a “natural stimulant”.
The list contains 10 different manufacturers covering 15 separate products.
The specific violation cited in the letters was that current law states that when supplements contain dietary ingredients not marketed before October 15, 1994, manufacturers must submit the new ingredient for use as a New Dietary Ingredient, notifying FDA of evidence that supports a conclusion that use is safe. The agency said in the letters that this requirement had not been met.
Further the agency stated that the synthetic DMAA could not be a “dietary ingredient” under Dietary Supplement Health and Education Act of 1994 (DSHEA) which defines a dietary ingredient as a “vitamin, mineral, amino acid, herb or other botanical, a dietary substance for use by man to supplement the diet, or a concentrate, a metabolite, constituent, extract or combination of these substances.”
FDA has been known in the past to send out a flock of letters at once to stake out a policy decision.
The action appears some time in coming. DMAA has been marketed as a supplement appealing to fitness buffs seeking extra energy. The Army Times reported in December 2011 that the Department of Defense was pulling DMAA containing products from on-base sales pending a review of side effects after some the experiences of some soldiers.
More information on how the agency regulates dietary supplement is contained on an overview page at the FDA site.
