FDA issues draft guidelines for new review channels to encourage generic competition

Recently, the U.S FDA issued a draft guidance entitled competitive generic therapies (CGT) The new guidelines set up a new evaluation channel to encourage pharmaceutical enterprises to develop generic drugs for drugs with insufficient competition through policy support This is also an important step forward for FDA in promoting the development and marketing of generic drugs The new path of "competitive imitation therapy" is a significant progress in strengthening the competition of generic drugs According to the FDA reauthorization Act issued in 2017, if there is no more than one approved drug in the FDA "orange peel book" (including drugs approved by the treatment equivalence evaluation), this drug is considered to be inadequate competition for generic drugs Applications for generic drugs of this type can be eligible for CGT In this pathway, applicants can submit CGT qualification application at or before the submission of simplified new drug application (anda) FDA will speed up the Anda review of CGT identified drugs at the request of the applicant CGT identified many early benefits for applicants, including holding product development meetings with FDA to discuss possible scientific issues in research design or alternatives These early benefits also help to reduce the number of review cycles and the time required for approval For the first approved anda of the CGT, the applicant can obtain 180 days of market monopoly if other conditions are met So far, FDA has approved more than 100 CGT qualification applications, and has approved five andas with CGT qualification from August to December 2018 These successful precedents show that CGT review pathway can effectively promote new competition To ensure that there is sufficient competition in the market, patients can use safe and effective generic drugs faster and get the treatment they need ▲ Dr Scott Gottlieb, director of FDA (photo source: FDA official website) "we have been trying to reduce the barriers to the development of generic drugs, reduce the cost of generic drugs entering the market, so that patients can use more generic drugs approved by FDA for listing," said Dr Scott, director of FDA "Over the next year, the FDA will continue to promote new policies to promote generic competition, including complex drugs," Dr Gottlieb said in a statement It is reported that FDA will also issue additional guidelines for the development of specific complex generic drugs, including a series of guidelines to deal with regulatory and scientific challenges It can be expected that the approval of more generic drugs will improve the accessibility of new and good drugs and benefit more patients Reference: [1] statement from FDA Commissioner Scott Gottlieb, M.D., on new policy to improve access and foster price competition for drugs that face indequate generic competition Retrieved February 20, 2019 https://