Sec. 2. Findings
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Congress finds the following: Following the enactment of the Drug Price Competition and Patent Term Restoration Act of 1984 ( Public Law 98–417 ), the People’s Republic of China was able to corner the market on generic drugs, pharmaceutical ingredients, and related materials through its steady supply of readily exploitable labor and threadbare safety regulations. Ninety percent of the medications taken by individuals in the United States are generic, rendering them especially dependent on supplies originating in the People’s Republic of China.
The number of drugs produced outside of the United States doubled between 2001 and 2008. At present, 80 percent of the active pharmaceutical ingredients used in drugs taken by individuals in the United States come from overseas, mainly the People’s Republic of China and the Republic of India. The United States no longer produces penicillin, with the last fermentation plant phasing out of production in 2004. In 2008, the counterfeiting of Heparin precursor chemicals by a Chinese-based pharmaceutical plant led to the deaths of 81 individuals in the United States, with 785 more being severely injured.
The counterfeit product cost one-hundredth of the price of the real product, indicating a clear economic motive for distributing contaminated materials. In 2018, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, issued recalls of Valsartan, Losartan, and Irbesartan, common blood pressure drugs. The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, determined that versions of such drugs have been contaminated as a result of Chinese and Indian manufacturing practices and that one Chinese company, Zhejaiang Huahai Pharmaceuticals, had systemic problems of supervision , with the potent carcinogens N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), N-Nitrosodimethylamine (NDMA), and N-Nitrosodiethylamine (NDEA), for a period of 4 years before being detected.
During an October 30, 2020, hearing before the Health Subcommittee of the Energy and Commerce Committee of the House of Representatives, it was discovered that the Food and Drug Administration
(FDA)has data on active pharmaceutical ingredient facilities and locations because they regulate and inspect them. But the FDA does not know how much volume is produced at these facilities. A single plant could make 90 percent of global supply or 10 percent, but the FDA does not know. The FDA cannot determine the United States dependence because it does not thoroughly regulate or inspect the facilities where the key chemicals and raw materials to make active pharmaceutical ingredients are made. Domestic pharmaceutical facilities undergo far more rigorous inspections than manufacturing facilities in the People’s Republic of China. Since early 2020, the FDA recalled its inspectors from China and elsewhere to protect them from the Coronavirus. As a result, FDA inspections have plummeted to near zero for the past year. In 2010, the People’s Republic of China embargoed the shipment of rare earth metals to Japan as political leverage in its negotiations over a boating incident that took place between the 2 countries in the East China Sea. National security experts warn that if such an incident were to take place between the United States and China, and China were to embargo medicine and pharmaceutical ingredients, the United States would be helpless. Sun Yu and Demetri Sevastopulo, China Targets Rare Earth Export Curbs To Hobble US Defense Industry. Ars Technica, February 16, 2021, arstechnica.com/tech-policy/2021/02/china-targets-rare-earth-export-curbs-to-hobble-us-defense-industry/. United States dependence on Chinese medicine and pharmaceutical ingredients poses a national security risk. The United States is dependent on other nations, particularly China, for our generic medicine and key ingredients that are used to make these drugs. Inspections at Chinese facilities are inadequate compared to inspections at facilities located in the United States. The United States cannot rely on questionable inspections at facilities located in China. To protect Americans, we must encourage the development of essential generic drug manufacturing here in the United States and countries allied with the United States in a current defense effort for the 227 essential medicines and medical countermeasures identified by the FDA in accordance with Executive Order 13944, issued on August 6, 2020.
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- Pub. L. 98-417
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