December, the last month of the calendar year, may (we hope) represent the new normal in the approval of generic drugs. But there may also be signs of concern regarding submissions on the horizon. The Office of Generic Drugs (OGD) had a modern day record in December with 79 full approvals and 20 tentative approvals for a total of 99 approval actions for original ANDAs for the month.
In what appears to be an effort for FDA to harmonize their treatment of combination or co-packaged prescription or over-the-counter drug products, the Agency has published a 70 page Federal Register Notice addressing this issue. The proposed rule notes that “[U]nder proposed § 300.53, two or more active ingredients may be combined in a fixed-combination […]
Thanks for reading our blog this year, We write them with feeling and lots of cheer. With GDUFA, QbD, and OPQ to understand, Our team searched for news from throughout the regulated land. The year 2105 went by so quick, Picking the best blog topics was really the trick. We hope you have gained […]
Zachary Brennan of RAPS wrote a nice explanatory piece about a new bill introduced by Senator Ted Cruz (R-TX) and Senator Mike Lee (R-UT) called the RESULT Act, which stands for “Reciprocity Ensures Streamlined Use of Lifesaving Treatments” Act (S. 2388). In effect, the Act would permit reciprocal approvals by FDA for drugs approved in a certain list of countries. In addition, the bill would give Congress the authority to override certain non-approval decisions by FDA for drugs for life-threatening conditions and require FDA to make decisions on such drugs to treat life-threatening conditions in 30 days.
Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research presented to the Centers’ priorities for 2016. I thought I would concentrate on what Dr. Woodcock said about the generic program priorities and try to provide some color.
FDA released a presentation by John Jenkins, M.D., Director, Office of New Drugs at CDER. The report is rather astounding and signals that the PDUFA program and the way FDA approached drug approval is not only collaborative but also thorough. One rather amazing piece of information is the first action approval rates for FY 2015. […]
The FDA approved Vistogard (uridine triacetate) as an emergency treatment for patient having severe toxic reactions or receiving an unintentional overdose of either fluorouracil or capecitabine. The treatment is a breakthrough for these patients and can be a life saver and/or permit earlier reintroduction of necessary chemotherapy.
We have read a lot about the significant rising cost of some generic drug products, some shortage products, and some old products without competition, even though any period of patent or exclusivity has expired. The entire issue of pricing appears to be focused on a handful of drug products. We certainly don’t want to see the system keep patients from getting the drugs they desperately need and we don’t want to break the bank of private pay patients, insurers, and local, state, and federal governments. So there needs to be a balance. How do we achieve that balance?
The news is that the FDA is postponing its decision on its Proposed Labeling Rule until July 2016. Mark that month on your calendar because it will mark the time where either FDA adopts a modified position or the legal process will likely be initiated by many in the generic industry.
As we previously reported (here), OGD approved 61 ANDAs and Tentatively Approved 6 ANDAs in November; thus there was appositive reduction of 24 applications in the theoretical backlog. This is (somewhat) the good news and the bad news. The good news is that OGD should have substantive excess review resources available, based on a reduced number of applications received. The bad news is-you are going to pay more for fewer applications.
