FDA set another record for generic approval in fiscal year 2018

The FDA Office of generic drugs (OGD) approved 781 andas in fiscal year 2018, breaking the historical record of 763 approvals in fiscal year 2017, and 190 temporary approvals, totaling 971 approvals, setting a new approval record This is a good sign that generic approval is moving in a positive direction with the end of the first fiscal year of gdufa II On October 11, the FDA quickly publicized its record approval volume and its potential to help reduce drug prices FDA and HHS have also released relevant pictures on twitter, among which 971 approvals are highlighted on the pictures released by HHS, 95 of which are the first generic drugs 12% are complex generic drugs Source: HHS tweet source: FDA tweet message Scott Gottlieb, director of FDA, also highlighted this figure in a written statement, saying that FDA is trying to ensure that patients get affordable drugs, and generic approval data is an indicator of "starting to see the results of this effort." Gottlieb also tweeted that the FDA will focus its generic policy formulation in 2019 on "new proposals (including complex drugs) that provide more high-value opportunities for generic drug manufacturers, as well as improving overall efficiency and reducing generic R & D costs." But AAM, the generic trade group, is less optimistic AAM said in a statement that while appreciating FDA's efforts, increasing generic approval does not "automatically" create the competition necessary to lower prices "Not all new generic approvals will enter the market, and it is estimated that less than half of them will actually go on sale, which means that all the benefits of generic competition to help reduce the high price of brand drugs have not been realized In order to achieve the president's blueprint for reducing drug prices, policy makers and legislators should focus their attention and efforts on correcting market and legal imbalances, as well as policy abuses that prevent FDA approved generic drugs from being marketed " In response, the FDA said it had no direct influence on when and where the drug would go on the market after it was approved, because it was "a business decision of the manufacturer." "While the FDA can provide scientific and clinical expertise to assist in the development and approval of generic drugs, we do not have the authority to require the sponsor to market its approved products." In terms of Anda submissions, the volume of Anda submissions again exceeds the FDA's forecast for calculating user fees prior to the start of fiscal 2018 In fy2018, 1044 original andas were received This is the third highest number of new anda submissions since the implementation of gdufa, with 1473 submissions in fy2014, followed by 1306 in fy2017 The lowest number of submissions was 539 in fy15 FDA expects submissions to decline by the end of fy2019 But Bob Pollock, a senior copycat in the pharmaceutical industry, doesn't think so He said, "submission volume seems to rebound every year, and it's hard to see any trend What we can see are many new company names on the daily approval list This is reminiscent of the early years of the hatch Waxman act, when several new companies emerged trying to take advantage of this lucrative market We also note that many new Chinese companies have been approved The new company starts with one or two andas a year, and then starts to work In my opinion, I doubt that we will see a significant decline in the number of Anda submissions in the next few years If small and new companies succeed early, we may even see record breaking submissions "