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All drugs in the United States are made in federally approved laboratories.True or False?

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Final answer:

It is false that all drugs in the U.S. are made in federally approved labs. Instances of fraudulent practices in drug manufacturing have occurred, and while the FDA's rigorous testing protects consumers, it can also delay access to important medications and impose high costs on manufacturers.

Step-by-step explanation:

The statement that all drugs in the United States are made in federally approved laboratories is false. While it is true that the Food and Drug Administration (FDA) regulates the medicines that pharmacies are allowed to sell to ensure safety and efficacy, not all drugs may be manufactured in federally approved labs.

There are instances where companies have engaged in fraudulent activities, such as submitting falsified data during the FDA approval process.

An example was the scandal involving generic drug manufacturers in the late 1980s and early 1990s, where companies such as Vitarine Pharmaceuticals and Bolar Pharmaceutical Company were found to have committed irregularities and fraud.

The approval of drugs by the FDA involves rigorous testing, which can take several years. The winners in this regulatory system are the consumers who are protected from unsafe medications.

However, the anonymous losers might include patients who need access to potentially life-saving drugs that are delayed due to the lengthy approval process and the high costs associated with it. Another set of losers could be manufacturers of generic drugs who face delays and additional hurdles in proving their drugs' equivalence to brand-name drugs.

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