Are generic drugs really as effective as brand-name drugs? This is what is introduced in the textbook, but many people have had different experiences in real life, and now even the US political and military do not fully agree with the claim that all generic drugs are equivalent to brand-name drugs.
1. The quality of generic drugs has attracted the attention of the U.S. military
It is no secret that the U.S. military does not trust the quality of generic drugs, and their disagreements and disagreements with the FDA over the quality control of generic drugs have long been made public. For example, many doctors have long warned that certain generic drugs of tacrolimus (tacrolimus) do not work well in the FDA. Tacrolimus is an immunosuppressive drug used to reduce the risk of rejection after allogeneic organ transplantation. However, it was found that some low-quality generic tacrolimus drugs may even cause kidney failure and seizures. Valisure, an independent laboratory commissioned by the U.S. military to test tacrolimus, found that the version produced by India's Intas Pharmaceuticals Ltd was not identical to its brand-name drug. The quality of Tacrolimus is just the tip of the iceberg of the crisis lurking beneath the surface. Miranda Janvrin, a researcher commissioned by the U.S. military, likened generic drugs to mimicking "deceased grandmother's baked cookies," with no recipe for the ingredients. The differences in the production process determine that there may be differences between generic drugs in terms of quality, including impurity components, content and release speed, and brand-name drugs that may lead to some serious consequences.
The U.S. military, trapped by inferior generics, is getting rid of the FDA and conducting a two-year quality review of 42 drugs, each made by multiple generic drug companies, with Valisure, an independent laboratory. The criteria for evaluating these different versions include potency and impurities. The military will use these results as a basis to screen for the highest quality generic drug manufacturers. While there is still a year to go before this project is completed, Valisure has clearly checked out a lot of issues. Valisure President David Light highlighted a disturbing outcome related to the high blood pressure, angina drug Metoprolol. For example, dissolution tests measure the extent and rate at which a solution is formed in dosage forms such as tablets, capsules, ointments, etc. The dissolution of a drug is very important for its bioavailability and therapeutic efficacy. Light said Valisure found that the actual dissolution difference between generic and brand-name drugs ranged from 4 to 53 percent. This means that those generics with dissolution differences above the threshold may not function as well as they should, and may even cause adverse effects.
The main disagreement between the FDA and the U.S. military is that the military expects the FDA to check the quality of generic drugs, while the FDA believes that their primary responsibility is to supervise manufacturing agencies, review their documentation and inspect factories, but not directly control the quality of products. FDA does not routinely test raw materials, drug substances, and finished drug products. During FDA inspections, they focus on compliance content rather than sampling and testing themselves. The website of the FDA's Office of Generics states that "all approved generics have the same high quality, strength, purity, and stability as brand-name formulations." It is on the basis of this assurance that drug wholesalers and pharmacy benefit managers (PBMs) in the United States are looking for generic drug manufacturers around the world that offer as low prices as possible. However, in the coming months, Valisure's data will come out, and the FDA's insistence that "all generics are of the same high quality" may become untenable. Valisure caused an uproar when he detected dimethylnitrosamine (NDMA) carcinogen in ranitidine.
2. The rise of generic drugs and regulatory rules
The boom and problems with generic drugs came after the Hatch Waxman Act was officially enacted. Previously, developers had to wait until the brand's patents had fully expired before they could...
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