FDA aims to reduce drug costs A new program will be unveiled

Today, President Trump, along with the U.SDepartment of Health and Human Services and the U.SFood and Drug Administration (FDA), issued a proposed rule-making noticeThe proposal is intended to determine whether certain prescription drugs are allowed to be imported from Canada, according to the drug-intelligence journalistThe proposed rules will be announced on the 23rd of this month's proposed rule-making notice, released today, is the first step in implementing a federal law that allows the import of certain prescription drugs from Canada under certain conditions to ensure that imports do not pose additional risks to public health and safety, while significantly reducing the cost of insured products for U.Sconsumers"Today's announcement outlines two ways to safely import certain prescription drugs to help deliver safe, effective and more affordable drugs to U.Spatients," said Alex Azar,secretary of health and human servicesThese are historic actions by the Department of Health and the FDA, and President Trump has recognized the opportunity to reduce patient costs in the United States through safe imports, and we, the U.SDepartment of Health and Social Services and the Food and Drug Administration, are implementing this possibility in a safe, common-sense wayproposed rule-making notice would allow states and some other non-federal entities to submit proposals for import plans to the FDA for review and approvalImport plans can be submitted by pharmacists, wholesalers, or other state or non-federal entitiesThese programs, known as the 804th Import Program, are authorized by the FDA to regulate the import of certain prescription drugs approved in Canada and meet the conditions in FDA-approved drug applicationsEligible prescription drugs must be relabeled as U.S.-compliant before importing and tested for authenticity and degradation to ensure that the drug complies with established specifications and standardsIt's worth noting that these programs must also demonstrate significant cost-cutting to U.S consumers In addition, the U.S government announced that a new draft industry guidelines have been issued that describe the procedures that drug manufacturers must follow to promote the import of prescription drugs, including biologics, which are approved by the FDA, produced abroad, licensed for sale in any other country, and are scheduled to be sold in that country and the draft guidelines describe the procedures for drug manufacturers to submit documents certifying that products imported from any foreign country are FDA-approved drugs and are manufactured in accordance with ANFDA-approved applications Notably, the draft guidelines describe the procedures that drug manufacturers must follow in order to obtain additional national drug codes (NDCs) for certain prescription drugs approved by the FDA, which were originally manufactured abroad and intended to be sold abroad The use of additional NDCs will allow drug companies more flexibility in offering these products at a lower price than current distributors require the draft guidelines also recommend that drug manufacturers add a statement to product labels and prescription information to help pharmacists accurately identify, distribute, and issue billing for these products Prescription drugs, including biologics, imported in accordance with the draft guidelines can be made available to patients in a variety of environments, including hospitals, health care providers, or licensed U.S pharmacies, and will include FDA-approved labels (including prescription information) "The FDA will continue to evaluate and take action to leverage multiple opportunities to promote competition, which will help lower drug prices and improve the difficulty of buying medicines for U.S patients," said Brett Giroir, assistant secretary of the U.S Department of Health, The proposed draft rules and guidelines are designed to protect public health and safety We look forward to receiving public comments on these draft policies, which we will take into account in a timely manner in finalizing the rules and guidance Our ultimate goal is to provide a strong plan that clearly defines the procedures for importing medicines that offer lower prices while maintaining the high quality Americans expect proposed rule notification part of the original text: Today, President Trump, along with the U.S Department of Health and Human Services and The U.S Food and Drug Administration, issued a notice of the proposed rulemaking (NPRM) that, if, will for the importation of the certain prescription prescription prescription from Canada In addition, the administration is is the availis of a new draft for industry, that describess s inprocedures, drug can's can follow-up to the in-country of prescription drugs, the elysing biological products, the are-a-fda-approved, manufactured abroad, authorized for the sale in foreign any country, and the original ly sin for the country the NPRM issue ddis is the first step in the first step in the gives a severing of the federal law will will will allow for the in-nation of the in-the-health of the in-city of canada,in-the-city sans ein sita no ss health and safety dysdd a's in the cost of the cost of the american The draft edd a dd yns sys s it s for a drug to submit the edding, the product offer for import from any foreign country is, in fact, an FDA-approved drug product, ceing it is manufactured in accordance with the FDA-fda-ofd application.