Today, the FDA announced the appointment of Sally Choe, PhD to succeed Kathleen (Cook) Uhl, M.D. as Director of the Office of Generic Drugs (Cook’s last day at OGD will be March 2). Dr. Choe currently serves as Deputy Office Director, Office of Study Integrity and Surveillance within Office of Medical Products and Tobacco, Center for Drug Evaluation and Research,
OGD just released its official January approval figures and we nailed it in our previous post here, where it was reported that OGD would have 102 approval actions in January, despite the shutdown. Well, we actually hit the nail on the head, as OGD did indeed break the 100-approval action mark by fully approving eighty-one ANDAs and tentatively approving twenty-one ANDAs.
In our blog, over the years, we have addressed the issue of dietary supplements and some actions of bad actors relative to the chase for the almighty dollar. Today, Commissioner Gottlieb announced the “agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight” (here) .
The Dietary Supplement Health and Education Act (DSHEA) was passed some 25 years ago and,
Required by Section 914 of the Food and Drug Administration Amendments Act of 2007, the annual report of the impact of 505(q) petitions and petitions for stay of action issued this last Thursday. This report discussed the number of such petition and describes any delays in approval that such petitions may have caused. The report covers FY 2017.
As we previously reported here and here, December receipts are missing from the update, even though the rest of the December metrics have been updated (see below). Well, they are not really missing (other than in the report), they just have not been figured out by FDA, due to the issues associated with the shutdown and the inability of FDA to collect user fees during the shutdown period.
Day Two started with a recap of Day One (see post from yesterday here) by Dr. Nancy Snyderman.
Day Two kicked off with a session entitled Generics Help Patients, How Can Patients Help Generics. This centered on digital virtual prescribing, digital physician visits, and what’s going on in that space.
The annual meeting of AAM, Access 2019, is being held in the Hyatt Regency, New Orleans from February 4-6, 2019. The agenda of February 4th involved several sessions to be attended only by the members, including that of Science & Regulatory and Policy Working Group, and the Board Meeting. The Science & Regulatory Team discussed about the future of GDUFA and BSUFA,
Even with the 35-day government shutdown and the stress that came with it, it appears that OGD has broken the 100 approval action barrier again with what looks like (so far) 102 approval actions posted for January as of February 4th. The data is taken from the FDA All Approvals list here .
Each year, the Association for Accessible Medicines (AAM) publishes its report on generic drug savings (here). The data is based on the independent IQVIA organization’s findings. Some interesting findings in the forty-page report are outlined below:
- 93% of generic prescriptions are filled at $20 or less.
- The average co-pay of for a generic product covered by insurance is $6.06 compared to an average brand co-pay of $40.30.
FDA notes on its User Fee web page (here) that the key date for acceptance of NDAs, BLAs, and ANDAs will be dictated by the first date that FDA could accept fees under the appropriation (after the shut down was over) which is January 28, 2019. The Agency gives the following advice as to how it will treat fee-paying applications and time periods for which fees must be paid (if not submitted at time of original submission of the application) (please see below):
- For ANDAs transmitted to FDA during the lapse period,
The Drug Price Competition and Patent Term Restoration Act of 1984 requires the FDA to publish a notice of all approved products and their marketing status. The FDA satisfies this requirement by publication of the drug products in the Orange Book; the FDA will publish information in the active section (if the product is currently being marketed) or the discontinued section (if it not being marketed for other than safety or efficacy reasons).
With 5 working days left in January, and despite the turmoil this month has seen, we stand at 58 Full approvals and 17 Tentative approvals reported on the FDA All Approvals page (here) through January 24, 2019.
Looking at the first quarter approvals (October thru December), there were a total of 278 full approvals which,
Today, the FDA published its required Activities Reports of the Generic Drugs Program (FY 2019) – FDARA Title VIII, Sections 807 and 805 (here). These reports are published quarterly, as required by law, and outline the following activities: ANDAs subject to priority review, ANDAs with a competitive therapy designation (CTD), and pending suitability petitions (a first-time report issued by the FDA).
After thinking about our blog post yesterday (here http://www.lachmanconsultants.com/2019/01/the-20-day-window-catch-how-will-it-play-out-and-other-questions/), it now becomes clear why the update to receipts and approvals for the December posting of the Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/abbreviatednewdrugapplicationandagenerics/ucm375079.htm) left out the number of December receipts. It is because the FDA has not yet decided how to handle application receipts that came in after the shutdown on December 22,
The unprecedented length of the government shutdown has a lot of people scratching their heads about lots of things. From a personal perspective, I have heard that FDAers are still getting paid (Commissioned Corps and civil servants) but the unknown is, for how long? When will the user fee money really run out? Has FDA been able to use the money that they collected for the applications submitted between October 1,