The U.S. House of Representatives passed the 21st century cure bill, and FDA's new drug review may be further reformed

Source: China Chemical Pharmaceutical Industry Association July 13, 2015 [news event]: the U.S House of Representatives voted 344-77 today to easily pass the long debated 21st century cures act "21st century cure act" is another milestone of new drug development legislation It not only further promotes FDA's reform of new drug review, but also endows NIH with more research resources to promote the development of basic medical research The 21st century cure bill was proposed by the House Energy Committee in April 2014 Its implementation will change the situation that the National Institutes of Health (NIH) has been stuck in the budget of 9 billion US dollars for many years In the next five years, it will increase the financial allocation of 8.75 billion US dollars, and the funding of FDA will increase by 550 million US dollars [drug source analysis]: the 21st century cure bill was jointly proposed by Republican representative Fred Upton and Democratic Senator Diana DeGette It aims to reform the drug regulatory policy, accelerate the drug approval needed for treatment, and fill the gap between medical research, the pharmaceutical industry and drug regulation After 12 round tables and 8 congressional hearings attended by patients' rights organizations, non-profit groups, academia, industry, regulators and legislators, the energy committee of the house of Representatives released the discussion draft of the "twenty-first Century healing act" in January 2015 and publicly solicited opinions from all parties On May 21, a revised version of the 21st century cure bill was voted by the House Energy Committee on a show of hands The 21st century cure bill passed today mainly includes two goals: one is to further reform the drug regulatory process, especially to shorten the approval of drugs needed for treatment; the other is to strengthen basic medical research and encourage medical innovation As we all know, in order to be approved for marketing, a new drug must be clinically verified for its efficacy and safety, and these clinical trials usually contain enough samples, multi center, randomized, double-blind, and controlled trials FDA in the United States is the benchmark of the global drug regulatory agencies, and its achievements in the past decade are obvious to all It has launched a variety of channels such as fast track, priority review, accelerated approval, and "breakthrough drugs" to shorten the approval time, especially for drugs that do not meet the market demand It has created a myth that it took only four days from receiving the declaration to approving the listing The 21st century cure Act requires FDA to further integrate the drug regulatory process, emphasizing the role of patients in drug approval Give more flexibility to drug approval, for example, the review of antibiotics can adopt small clinical trials combined with pre clinical results, accept biomarkers or other alternative clinical endpoints The author believes that accelerating the approval process of drugs cannot be at the cost of reducing the standard of drug efficacy and harming the health of patients And as we discussed today, we have not yet entered into "communism" and have not reached the "infinite richness" of social resources The limited resources of human society should encourage new drug development activities that are clearly different from existing standard therapies In fact, this is also the concern of some industry experts about the 21st century cure act The new bill is a double-edged sword On the one hand, "short or small clinical trials" or the use of alternative clinical endpoints can significantly accelerate the output of new drug development On the other hand, it is bound to affect the quality of new drugs on the market to varying degrees, and at the same time, it will also reduce the current treatment gold standards - the value of these drugs after large-scale clinical trials Moreover, "evidence from clinical experience" includes "observational studies, registers, and therapeutic use" as the declaration of new indications of drugs on the market, which greatly encourages the "non prescription use" without clinical verification Although these post marketing statistics can provide some efficacy and safety data, they are far less reliable than those of randomized controlled trials In fact, FDA approval of about a third of new drugs uses only one key clinical trial result with an average of 760 participants Two thirds of clinical trials have a real experimental period of no more than half a year, including which therapies are used for life Moreover, the approval time of FDA for most drugs is less than 10 months, so the FDA has not become the bottleneck of new drug development.