August 10, 2018
If the US government and the FDA have their way, Americans may soon have more access to medications and prescription drugs without having to first see a doctor. This is undoubtedly a positive step in the right direction. Unfortunately, it’s not exactly what you might think.
For those who are unaware, in the United States, an allegedly free country, American citizens no longer have the option to decide what medications they believe they need or wish to take and simply purchase those medications from a pharmacy as in times past or as in many other countries today. Instead, they are forced to make an appointment with a doctor who is considered (and considers himself) the ultimate authority on what a patient can consume, regardless of the patient’s choices. Of course, the patient has to pay for that visit and he/she may not even be prescribed the proper medicine even after begging the doctor’s permission to access it. The patient then has to go to the pharmacy and prove that he has his hall pass (prescription) in order to be receive his medication.
Now, a new draft guideline from the FDA seems to be heading in the opposite direction but “seems” is the operative word here. The FDA is looking into to how it can “lower healthcare costs” and one of the options may be opening up certain medications to potential purchase without a doctor’s visit.
But before anyone gets the idea that America is inching its way back to freedom, you might want to slow down. Independent thought and individual choice is not on the menu just yet.
One idea is that patients could answer questions on a mobile-phone app to help determine whether or not they should be able to have access to a medication without needing a prescription.
“Our hope is that the steps we’re taking to advance this new, more modern framework will contribute to lower costs for our health care system overall and provide greater efficiency and empowerment for consumers by increasing the availability of certain products that would otherwise be available only by prescription,” FDA Commissioner Scott Gottlieb said in a statement.
In 2007, the FDA explored a similar idea that would have required an interaction with a pharmacist.
The move is not expected to “lower the bar” for drugs’ over-the-counter status, however.
Furthermore, another question arises regarding the cost of such medicines since insurance does not cover over-the-counter non-prescription drugs.
As Bloomberg reports,
The proposal is meant to help companies start thinking about how they might seek approval for such drug sales. A new FDA regulation that would make the pathway official is expected next year. The move isn’t expected to lower the bar for shifting prescription drugs to over-the-counter status, Gottlieb said.
Finding a way to expand access to widely used prescription drugs has been a goal of regulators in recent years.
The FDA explored the idea of a “behind-the-counter” designation in 2007 that would have required interaction with a pharmacist. The Government Accountability Office in a 2009 report on the proposal asked whether consumers would end up paying more for their drugs since nonprescription medications typically aren’t covered by insurance.
The idea resurfaced in 2012 when the FDA evaluated whether to reclassify treatments for high blood pressure, cholesterol, migraines and asthma as nonprescription. The market for such medicines is vast: Global sales of cholesterol-lowering drugs totaled $7.33 billion last year, according to Bloomberg Intelligence.
Slightly more than half of U.S. adults, or about 43 million people, who need cholesterol medication are taking it, according to the Centers for Disease Control and Prevention. About 75 million Americans, or one out of every three adults, have high blood pressure, though only about half of them have the condition under control, according to the CDC.
The GAO report suggested that drugs that combat life-threatening allergies, such as Mylan NV’s EpiPen, could benefit from similar nonprescription status. Gottlieb in his statement on Tuesday also said that naloxone, the opioid-overdose antidote, could follow the proposed pathway. Naloxone is available without a prescription in most states, though access has been reported to be limited.
Drug companies would have to submit data to the FDA that shows consumers are capable of accurately assessing their need for a medication and their ability to use it correctly.
“Our ultimate goal with modernizing our regulatory framework for nonprescription drugs is to help facilitate a market that is more competitive, enables greater access to medical products, empowers consumers in their health care decisions, and provides more affordable options for Americans,” Gottlieb said.
So clearly the goal here isn’t adding more freedom to the market since whatever the FDA decides will involve patients having to ask permission of someone (doctor, pharmacist, government computer system) before being able to purchase their medicine. But the question is whether the FDA is really trying to lower the cost of such drugs or just trying to raise the sales of the companies who manufacture and distribute them.
Only time will tell. However, there is still the possibility of an optional Medicare For All system that covers everyone a country that allows its citizens to choose what they put in to their bodies, even if no one (yes, including Bernie) is talking about it. After all, given the history of the FDA and the current standings of dangerous pharmaceuticals, individuals really couldn’t do any worse could they?
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Brandon Turbeville – article archive here – is an author out of Florence, South Carolina. He is the author of six books, Codex Alimentarius — The End of Health Freedom, 7 Real Conspiracies,Five Sense Solutions and Dispatches From a Dissident, volume 1 and volume 2, The Road to Damascus: The Anglo-American Assault on Syria,and The Difference it Makes: 36 Reasons Why Hillary Clinton Should Never Be President. Turbeville has published over 1,000 articles dealing on a wide variety of subjects including health, economics, government corruption, and civil liberties. Brandon Turbeville’s podcast Truth on The Tracks can be found every Monday night 9 pm EST at UCYTV. He is available for radio and TV interviews. Please contact activistpost (at) gmail.com.