The federal government should provide incentives to encourage drugmakers to produce key drugs and active pharmaceutical ingredients, the alliance of supplier organizations urged in a series of policy recommendations issued on Thursday.
The American Medical Association, the American Association of Anesthesiologists, the American Association of Health System Pharmacists, the Association of Clinical Oncology, and the United States Pharmacopeia urge pharmaceutical suppliers that develop continuous manufacturing infrastructure in the United States and abroad to help alleviate drug shortages. Report.
Continuous manufacturing, unlike Mass production, Use a fully integrated assembly line to produce small quantities but can be quickly rotated to manufacture different drugs.
Tom Krauss, vice president of government relations for the American Association of Health System Pharmacists, said: “These mass production facilities are fragile because it is difficult to convert these production lines to other products.” “Compared with large factories that produce large quantities of one drug extremely efficiently. , The continuous production base can produce various ingredients on a smaller scale on site.”
This COVID-19 pandemic With the sudden cessation of overseas supply of medicines and personal protective equipment, the fragile links in the healthcare supply chain have been magnified.Employee safety and care Quality impaired Suppliers are scrambling to find alternative sources.
National Strategic Reserve Basically failed Fill in these gaps. “There is no transparency. Different agencies have sent different messages about what is in the national strategic reserve and how to obtain it,” Klaus said. “There are many ways to incentivize private sector inventories, such as favorable financing provided by the government, allowing the health system, [group purchasing organizations] Or the manufacturer holds inventory. “
Supplier groups suggest that the federal government can increase the supply of drugs by offering tax incentives to pharmaceutical companies that include continuous manufacturing.
These organizations believe that in addition to encouraging the supply of reliable drugs and active drugs, policymakers should also enact legislation to strengthen national strategic reserves, improve cooperation with foreign manufacturers, reward quality manufacturers and increase reporting requirements.
These groups said that regular updates of the national strategic reserve inventory, including monoclonal antibodies against various pathogens, will help respond to public health emergencies.Wholesalers and distributors should also report the supply level and location of their contract manufacturers, which is usually Sources of quality incidents.
“The location of the contract manufacturer is an issue we continue to focus on. If the pharmaceutical or equipment supplier has multiple manufacturers, they seem to have a diversified network, but if they rely on one contract manufacturer, this is not the case,” Crowe Said. “We need the FDA to clearly understand these supply disruptions.”
Health system created PPE manufacturing plant in the U.S. As a stopgap measure during the epidemic.Although suppliers want to diversify their suppliers instead of relying mainly on Chinese resources in the long run, many of them are local companies Failed With low-cost foreign manufacturers resuming production.
Healthcare systems have historically relied on lean, timely inventory strategies under which suppliers store a limited number of personal protective equipment on site and order more as needed. But many suppliers have stocked more equipment and signed long-term contracts with suppliers and distributors, so they can use more equipment.
Civic RX Krauss said that some GPOs have also helped support the supply of generic drugs that continue to be in short supply, and the government can do similar things.
The supplier organization recommends that the Food and Drug Administration should require drug and device manufacturers to publicly report quality indicators that measure reliability, which will promote high-quality facilities and anticipate supply disruptions.
Currently, the only tool the FDA requires to increase transparency is to try to humiliate the company through public letters. According to supplier groups, it is believed that failure to report “prohibited behavior” will pave the way for more severe penalties.