Brief report of the 2019 annual meeting of American generic drugs

The annual meeting of AAM in 2019 was held in New Orleans from February 5 to 6 The theme of the annual meeting is "access!", focusing on the accessibility of generic drugs Let's take a look at the hot discussions in the briefing on the contents of the conference and what reference value these discussions have for China's pharmaceutical industry The agenda for the first day of the conference covered several panel discussions on various aspects of the generic and bioequivalent pharmaceutical industry, including barriers to approval, fair pricing, supply chain related challenges, global and US trends related to generic drugs, etc The discussion highlighted barriers to market access for bioequivalent drugs, including potential clinical issues that appear to be related to negative publicity and misinformation, as well as economic and patent issues Because although 17 biological analogues have been approved in the United States, only five are on the market at present Another topic of great concern is the inequality between the approval of Anda and the listing of approved generic drugs, as well as the driving factors According to iqvia data, although more than half of the approved andas did not go on the market immediately, after about a year of approval, the proportion dropped to about 40% The first step to address this situation is the requirement that manufacturers provide written notice to FDA in the "Notice of sales status" guideline just released by FDA that drugs cannot be sold within 180 days after approval Domestic enterprises that have product application for FDA need to pay close attention to this trend, and only require written notice at present However, in view of the recent hot discussion on the rise of drug price and the gap between the approval and listing of generic drugs in the United States, the U.S regulatory authorities will seek further action There are also some discussions about the pressure on the U.S generic price to keep falling, which has a negative impact on the generic industry It was pointed out that no matter how small and reasonable the price range of generic drugs or brand drugs was, any type of price increase would easily become the target of criticism Chip Davis, chairman and CEO of AAM, stressed that the generic industry needs to be proactive in its voice There is a saying in Washington that "if you are not at the table, you are on the menu" vividly shows that the industry as a whole speaks and tries to make its voice heard by lobbyists China has been one of the major API suppliers in the United States for many years, but the voice of China's industry representatives in the United States is relatively weak AAM, as a representative of American generic pharmaceutical industry, has always been involved in the negotiation and lobbying to Congress or FDA, but it does not seem to be as powerful as the lobbying efforts of pharma (Association of brand drugmakers) and bio (Association of biopharmacers) AAM has been reflecting on this issue, and this work may also be one of the directions that the domestic industry should think about in the future The next day's telemedicine conference started with the topic "generics help patients, how patients help generics" This topic mainly focuses on the digital virtual prescription, digital doctor's visit and some other things that are happening in the field of digital medicine The panel described the impact of digital doctor visits and the impact of mobile devices on the provision of healthcare services to people who lack access to medicines In this way, doctors' visits can be directly loaded into the payment system, and even patients can get treatment directly in the form of prescription Imagine the extra revenue that could be generated for the pharmaceutical industry by using such a system and being able to reach directly the population of patients with few medicines Telemedicine has become an important business, and it has been extended to the people who are short of medicine at a much lower cost than traditional medicine, which is beneficial to patients and pharmaceutical companies Telemedicine can be regarded as a cost reduction measure, especially telemedicine has lower service cost, no clinic, no road traffic time, lower cost, all you need is digital access Participants said this could also translate into lower deductibles for patients The discussion of this topic is also of reference significance to the domestic industry In September last year, the national health and Health Commission issued trial management measures on Internet diagnosis and treatment, Internet hospitals and telemedicine services, defining Internet diagnosis and treatment for the first time and clarifying management norms What opportunities can the domestic pharmaceutical industry find? The second topic of discussion on drug pricing is drug pricing, the opioid drug crisis and the concept of opioid drug taxes that some states are promoting Experts warn against overreacting to the opiate crisis, as the majority of deaths from overdoses are caused by illegal drugs, such as fentanyl and heroin There was a consensus on the need to take a reasonable approach to opioid problems and to focus on patients suffering from intractable pain The price of generic drugs is another hot topic The panel noted that generic prices have been deflationary for the past few years, and that they can save consumers money compared to the same branded products Brand medicine products are the real cause of the problem The speech of the Secretary of health and Alex Azar, the Secretary of the Department of health and human services (HHS), did not disappoint He evaluated the benefits of generic drugs and the "tricks" of brand drugs to maintain their monopoly market The following is the focus of Azar's speech: generics bring about successful cost reduction and health care system savings discussed the president's health policy blueprint and the role of generics in the implementation process, which requires appropriate incentives in the payment system to enhance and promote competition without increasing prices (domestic "4 + 7 How to give incentives without increasing the price?) Not only is the safety and effectiveness of generic drugs important, but also patient accessibility is important FDA's record number of Anda approvals in fiscal 2017 and fiscal 2018 can increase competition It points out that enforcement is needed to prevent brand drugmakers from using REMS programs and restricted distribution systems to prevent generic drugmakers from obtaining anda The orange peel book of sample reform required for regulatory research is required for declaration to contain more up-to-date information referring to the drugs on the market, and to better identify the drugs currently on sale and the drugs that have ceased to be sold The resource biological products required for the development of complex generic drug guidelines account for 40% of the drug expenditure The development of FDA It is essential to educate the medical community about the benefits of bioequivalent drugs, and identify the false statements made by brand drugmakers that harm the use of bioequivalent drugs Consider the import of high-cost or short drugs, and coordinate the regulatory requirements of the United States and the European Union in the Medicare part D It can save the government about 3 billion US dollars and the beneficiaries of the government's medical insurance about 1 billion US dollars in cash to reform the drug rebate system The current rebate system usually results in patients having to pay for brand drug products when generic drugs are available, Because the "backdoor rebate" of brand drugmakers will lock the drug contract with the insurance company and prevent the insurance company from paying for generic drugs, Azar's speech is authentic and full of indisputable facts and statistics Except for the problem of importing foreign drugs, each of his main views was applauded by the participants The discussion at the meeting covered almost all the current hot issues, and this year will not be a smooth year for the generic pharmaceutical industry Organize: are you at the table, or on the menu? Shouldn't that be an easy choice? Lachman consultants Two at AAM annual meeting – the big guns come out Lachman consultants