Abortion is a very controversial subject, but medicine safety is n’t.
Keeping America’s drug supply comfortable is a democratic effort. Whatever one’s social affiliations, everyone wants healthy, effective drugs, and a complete disclosure of known health risks.
In light of this, the Food and Drug Administration is supposed to be independent about politics, including the politicians of abortion, and its decisions are solely based on its goal of realistically making data-driven regulation decisions based on safety and efficacy.  ,
Is the FDA Behaving Aggressively?
The FDA has large discretionary authority granted by Congress to decide what medications are safe and effective, but its discretion is no unrestricted. The FDA has abandoned appropriate drug-safety practices when it comes to mifepristone ( for abortion ), not mandating that manufacturers gather all proof of how the drug harms women.  ,
When questionable FDA drug approvals are brought up by individuals or groups outside the organization, but the agency’s actions years later, including those involving mifepristone, have prompted further inquiries.  ,
For the first time, the FDA, at manufacturers ‘ request, permitted epidemiologically unsound wording specifying that providers are only mandated to collect reports of deaths, but not any other adverse events ( sometimes called side effects ) following mifepristone administration.
Typically, companies have properly proposed to collect all documented adverse events. But, the new language in the FDA-approved Risk Evaluation and Mitigation Strategy simply states that companies “e]nsure that any incidents of patients who received Mifeprex are reported to [manufacturers ] …”.  ,
Why not “ensure” the selection of all negative activities for a medicine that hundreds of thousands of women take annually?
Are suppliers and the FDA concerned about what they will discover? If the answer is “yes,” then all the more reason for people and suppliers of abortion to be informed of all the drug’s potential risks.  ,
The FDA’s dying- just safety- collection language is unique compared with another Risk Evaluation and Mitigation Strategy products, which use meaningfully firmer language for negative events, including:” …]medical providers ] had: At all times report …” in reference to any undesirable event that occurs.
Another FDA Risk Evaluation and Mitigation Strategy partners appear to have a clear interest in protecting and informing their clients, and to that conclusion, completely record all negative events, in contrast to mifepristone.  ,
More Than Incidents Are More Than Drug Safety Epidemiology
Death is not the only negative function that is significant when evaluating the health of drugs.
Similar to how a car manufacturer would like to obtain safety data about its vehicles, even collecting reports of car-related deaths may exclude all nonfatal injuries and conceal the true level of any defects or dangers, in analogy.
Consequently, consumers would n’t be informed about automobile failures resulting in serious injuries, such as dismemberment, burns, traumatic brain injury, or other permanent disabilities—which, although they might not ultimately result in death, are still critically important for safety assessments.  ,
Utilizing the latest FDA Risk Evaluation and Mitigation Strategy’s adverse-event collection language could lead to negative events that are never reported, leading to profit-driven manufacturers who could benefit from the absence of reported adverse events and then promote their drugs as having a stellar” safety” record.
Upcoming television and other media advertisements might seemingly and fraudulently emphasize the safety of at-home abortions, but they are still possible.  ,
Set Aside Pregnancy Elections and Protect People
Regardless of one’s social outlook on abortion, using mifepristone at home without supervision can have serious, clinically significant risks, which is why it was simply initially approved through a Risk Evaluation and Mitigation Strategy.  ,
Serious, life- threatening, modifying, and death negative events have been reported, and are far more likely to be avoided if a clinical abortion is used instead of biochemical abortion drugs. If chemical contraception is used, it should be done as safely as possible for women, be performed under the supervision of a doctor, and at least in accordance with the traditional Risk Assessment and Mitigation Strategy, Medication Guide, and Elements to Tell Safe Use requirements.  ,
The FDA should demand that all adverse events associated with using mifepristone for abortion be actively solicited and collected in the name of women’s health.
Manufacturers and the FDA can no longer rely on lack of evidence of harms to support their claims that mifepristone is safe, especially since the FDA stopped requiring the collection of proof of harms.
In order to perform their duties, drug safety experts require all safety data to be reported. The health of America’s women depend on it.  ,
