The FDA announced today that the total collectable amount of fees under the GDUFA program (adjusted for inflation and salary increases) will be $312,224,000, up from the original $299 million that was authorized for year 1 of GDUFA. The good news/bad news is that ANDA and PAS fees decreased.
The FDA announced the availability of two Guidance documents – on Prior Approval Supplements and the other concerning Easily Correctable Deficiencies (ECDs). These eagerly anticipated documents have also published on the CDER web page.
The FR notice states relative to the Prior Approval Supplements (PAS) Guidance that “this draft guidance is intended to assist applicants preparing to submit to FDA PASs and amendments to PASs for abbreviated new drug applications (ANDAs). It describes FDA’s performance metric goals for PASs and clarifies how FDA will handle a PAS and amendments to a PAS for an ANDA subject to the GDUFA performance metric goals.”
One of the hottest topics over the last few years has been that of drug shortages and what to do about them. The FDA video explains that the Food and Drug Administration Safety and Innovation Act (FDASIA) made important changes to the way industry must report drug shortages.
The FDA is proposing to update its list of drug products (previously found in its regulations at 21 CFR 216.24) that have been removed from the market for safety or efficacy and cannot be legally compounded. It has also revised one product relative to its dosage form that allows compounding under the pharmacy compounding exemption. Since FDA has approved an ophthalmic form of bromfenac, it has removed the restriction to now permit the compounding in certain situations for this drug product but only for ophthalmic use, whereas this drug was previously excluded for any use by the Rule.
I was asked by a reporter how the Office of Generic Drugs (OGD) and FDA were going to respond to the overwhelming number of abbreviated new drug applications (ANDAs) that have been submitted not only in June of this year, but to the record numbers of ANDA submissions in since 2012.
The Office of Generic Drugs (OGD) confirmed today that the rush to get ANDA applications into the Agency before the new stability requirements go into effect on June 20, 2014 flew past all estimates and landed at just under 600 (the unofficial count is 598). OGD was shocked by the number of submissions with many there predicting a figure around 350. The rush was certainly on with a total of about 370 ANDAs submitted in the last 4 business days leading up to the June 20 deadline. One positive comment from OGD was at least we know the Electronic Gateway can handle the volume!
The Generic Pharmaceutical Association (GPhA) commissioned a survey organization (PublicMind) to poll physicians, physician assistants and pharmacists about how much they knew about the proposed generic drug labeling rule, how it would impact their practice (if at all), and how they felt about the current system of how generic drug labeling is approved by the FDA. The survey had some interesting results, which are summarized below.
The Health and Human Services published its semiannual regulatory agenda and guess what popped up on review? The proposed date of finalization of the Rule on label changes that can be made by an ANDA holder relative to newly acquired safety information is listed as December 2014.
Looking more typical of a December number of ANDA submissions, the May 2014 number of 134 is just a blip before (what we believe will be) a very big June. Remember that firms will be hustling to get ANDAs in before the new stability requirements go into effect on June 20, 2014.
With the approval of only 20 ANDAs in May (information derived from the CDER application approvals report), a statistic that is sure to give CEOs heartburn, the industry may start to question the GDUFA goals, unless many more ANDAs are driven to approval. As I have written before, Complete Response Letters (CRL) are the measure of GDUFA success based on the GDUFA metrics, but you can’t market products that receive Complete Response Letters. If I am not mistaken, the 20 monthly approvals are perhaps the lowest since the generic drug scandal back in the late 1980s and early 1990s.
