As previously reported (here), Dr. Reddy’s generic of Nexium was too close to that of the innovator’s “Purple Pill”. Apparently, the firm has changed the color of its capsule and reintroduced the product. But, this does reinforce that fact that generic companies, despite the Office of Generic Drugs’ (OGD) input, desire to have the generics look more like their brand name counterparts.
Not too often do you see the public gather around an idea so emphatically and in such numbers. This struck me when I was looking through the public comments on Docket FDA-2014-N-1207. To date, there are about 3000 comments posted; all are available on regulations.gov.
The issue of the docket relates to the use of the word “natural” in the labeling of human food products.
The FDA has updated its pediatric exclusivity page (here); a search of the document reveals 9 different products received pediatric exclusivity during 2015.The number of awards of pediatric exclusivity in 2015 are substantially higher than the numbers from 2013 or 2014, when 6 awards were made in each of those years. What will 2016 bring?
Recently, FDA took administrative action by detaining at the border a product containing kratom, a plant material that may have the potential for abuse and potential serious health consequences. Then the Department of Justice filed a complaint in US District Court on behalf of the FDA “alleging, among other things, that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury; therefore, dietary supplements containing kratom are adulterated under the FD&C Act.”
OGD partially updated its Generic Drugs Activity Report for FY 2016 this morning and it must have found a few more receipts.
FDA recently released a revised draft Guidance outlining its new thinking on the bioequivalence requirements for paliperidone palmitate, representing still another BE guidance revision for a long-acting product, but this time for a long-acting parenteral suspension of this product for schizophrenia. The original draft BE Guidance document for this injectable suspension was issued in August 2011.
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 or co-packaged drug or included as a combination in an OTC monograph when two requirements are met.”
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.
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.