When it comes to the regulation of drugs Americans are not informed fully on what the FDA’s actions are. Overall, their job is to ensure the drugs will not cause a large amount of harm but there is a large amount of science they do not test. Richard Deyo, an MD from The Journal of the American Board of Family Medicine, wrote an address that started the FDA’s procedures are lacking by that statement that, “It does not review advertisements before use, assess cost-effectiveness, or regulate surgery (except for devices). Many believe postmarketing surveillance of drugs and devices is inadequate” (Deyo). Important factors like cost-effectiveness are not accounted for which leave families who cannot afford alternatives. This leads to asking what
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A long period of addiction to opioids in the country has been due to a large supply being sold behind the counter and behind the taco bell at three am. The spread of these opioids has been so bad not even the FDA has expected them. In a article written by Susan Okie, M.D, she stated that, “FDA officials have been scrambling to revise their proposed Risk Evaluation and Mitigation Strategy (REMS), after an advisory panel (the agency's Anesthetic and Life Support Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee) voted 25 to 10 against the FDA's plan, saying it didn't go far enough. If an Advisory committee is able to out-vote the FDA’s plan for opioid care by over 2-1 how deeply can they be trusted to protect and fulfill their duties? The proper training required to handle and prescribe medicine has not laid down by the FDA. Dr. Okie stated that “The FDA could require such training, but officials said doing so would be costly and would duplicate the DEA's registration system for prescribers of controlled substances. To make pain-management training mandatory for obtaining a DEA number, a change supported by the advisory committee, Congress would have to pass legislation” (Okie). Without proper mandates in place, the American people will constantly be at risk of opioid abuse due to their own uninformed action lead be the slacking FDA. Congress would have to force the FDA to fully do their job as their plans to date have been inadequate to handle this massive spread of opioid-induced panic. The FDA has also been lackluster with their performance in making certain the foods American eat are healthy and informing the public what they are truly
A long period of addiction to opioids in the country has been due to a large supply being sold behind the counter and behind the taco bell at three am. The spread of these opioids has been so bad not even the FDA has expected them. In a article written by Susan Okie, M.D, she stated that, “FDA officials have been scrambling to revise their proposed Risk Evaluation and Mitigation Strategy (REMS), after an advisory panel (the agency's Anesthetic and Life Support Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee) voted 25 to 10 against the FDA's plan, saying it didn't go far enough. If an Advisory committee is able to out-vote the FDA’s plan for opioid care by over 2-1 how deeply can they be trusted to protect and fulfill their duties? The proper training required to handle and prescribe medicine has not laid down by the FDA. Dr. Okie stated that “The FDA could require such training, but officials said doing so would be costly and would duplicate the DEA's registration system for prescribers of controlled substances. To make pain-management training mandatory for obtaining a DEA number, a change supported by the advisory committee, Congress would have to pass legislation” (Okie). Without proper mandates in place, the American people will constantly be at risk of opioid abuse due to their own uninformed action lead be the slacking FDA. Congress would have to force the FDA to fully do their job as their plans to date have been inadequate to handle this massive spread of opioid-induced panic. The FDA has also been lackluster with their performance in making certain the foods American eat are healthy and informing the public what they are truly