In the convoluted and verbose rules of government, the Food and Drug Administration is has accumulated entire repositories of research, regulations, and advisories intended to keep American consumers safe. Most FDA information is available as public documents included in the Code of Federal Regulations and various acts and legislative enactments concerning the agency.
Included in the various rules of the FDA are definitions of medical devices. Generally, the FDA defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is…intended to affect the function of the body.”
Some devices require a prescription and some can be purchased over the counter. Generally, a device that has any “potentiality for harmful effect” necessitates a prescription for use, as do those devices that are inserted into the body. Many considerations must be made to determine if a device is safe for non-regulated use or without the supervision of a licensed doctor.
So, why isn’t a condom a medical device requiring a prescription? It clearly is a contrivance that affects the function of the body. Some would argue that it is safe and only used outside of the body, but that is not the case. Condoms are used by one partner externally and the other internally. With the number of adults suffering various allergies, there is always a risk of some reaction to the condom’s materials, spermicides, and lubricants, and thus some potentiality for harmful effect.
Seems a man should need a prescription for a condom, the same way a woman needs one for her birth control.
On Friday, Donald Trump continued his unrelenting attack on America’s women — and his predecessor – by rolling back Obama-era mandates on reproductive health. The rule reversal is sweeping change to how employers are expected to pay for birth control and other reproductive health coverages. It will allow private companies to deny coverage for contraceptives and procedures that may “violate” the employer’s religious beliefs.
In other words, a white Christian bigot like Donald Trump could tell any freethinking moral woman how to treat her body. He can deny her family planning, contraceptives, and necessary reproductive care and procedures because “God told me so” without any legitimate regard for the woman’s health or safety. A male employer can decide whether a woman can get pregnant or not, and then — under the misogynistic Trump regime — likely tell her she cannot work because she is pregnant.
Day-by-day, Trump is erasing not only Obama’s progressive rules and regulations, but also 100 years of social progress in America. Women have been struggling to gain equality and the same rights as men since the nation’s inception 240 years ago. Their achievements have come and gone, and come again, in baby steps and increments. In only nine months in office, Trump has managed to destroy the delicate framework of equality that women have established.
There are almost 75 million working women in America — close to half of the civilian workforce and not including those enlisted in the military. Every woman who has access to employer sponsored or group health care coverage must be afforded the exact same rights and privileges as her male counterparts. That reproductive health can be isolated to only certain women’s health provisions is an example of the last bastions of male dominated policymaking that must be broken.
When the Obama-era rules went into effect with the Affordable Care Act — more commonly and kindly referred to as Obamacare — some religious organizations took offense to contraception mandates. One group, Sisters of the Poor, filed suit against the government claiming that their religious beliefs as a church prevented them from being compelled to provide female employees with contraception.
As a result of the Sisters of the Poor challenge and another by Hobby Lobby, the federal government offered religious organizations a very narrowly defined exemption to the mandate. It allowed that an employer’s insurance provider could work out details of reproductive care on behalf of the employer to circumvent the religious objection. The proposal worked for a short while and then Trump stole an election and promised religious groups he would repeal the mandate.
According to the Department of Health and Human Services, which announced the rule change on Friday, repealing the birth control mandate will affect only a “tiny” portion of working women. However, the point is that it should not affect any women — even so-called tiny portion. A woman should not be denied access to any kind of care because of someone else’s religious objections.
Already, challenges have been filed against Trump’s new mandate. Both the Massachusetts attorney general and the national ACLU have prepared briefs to prevent Trump’s repeal from taking effect. Years of litigation lay ahead for any ACA mandate focusing on women’s reproductive health and birth control. By the time a decision is made in any legal case, it is likely Trump will be long gone.
While the logistics of birth control are hashed out in the courts, there is another way to solve the problem of government interfering in a woman’s right to choose when to bear a child and with whom. Instead of deciding what is constitutional for women in the context of religious objection, the insurance and health care industries should act to make contraception equal at the medical level.
This whole argument, and years of litigation might easily be solved with one change to the FDA rules. Instead of continuing to allow condoms as an over-the-counter purchase and birth control pills available by prescription, why not require a doctor’s order for a condom. Let’s see how fast things change when a man’s employer has the right to say when he can have protected sex and when he cannot.