Final answer:
The Kefauver-Harris Amendment is the FDA regulation that required manufacturers to disclose possible dangers and side effects of their medicines. While the amendment increased drug safety, it also had negative implications for patients waiting for new treatments and small pharmaceutical companies struggling with regulatory compliance costs.
Step-by-step explanation:
The regulation that required manufacturers to disclose possible dangers and side effects of their medicines is the Kefauver-Harris Amendment of 1962. This law was enacted in response to the thalidomide tragedy, where a drug caused birth defects in thousands of babies. The enactment of this amendment also marked a significant increase in the oversight of drug safety by the Food and Drug Administration (FDA), ensuring new drugs to be both effective and safe before they can be marketed.
Beyond ensuring drug safety and efficacy, the FDA's strict medical regulations can have negative implications for some groups. These anonymous losers, as referred to in the question, can be patients who suffer from diseases for which there are no approved treatments, those awaiting the availability of potentially life-saving drugs, or small pharmaceutical companies that may find the cost of compliance with FDA regulations to be prohibitively high.