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.”
