What the Health? Prescription Drug Regulations, the FDA, and Senate Republicans Don't Give a $h!t

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<i>What the Health?</i> Prescription Drug Regulations, the FDA, and Senate Republicans Don't Give a $h!t

This week, we’re getting into prescription drug regulations and the FDA, but first I wanted to have a quick update on what is going on with healthcare reform in Congress. Presently, the Senate Republicans are currently coming up with their own version of the AHCA to put up for a vote potentially quite soon. This is alarming because they are not putting up the bill for a hearing process, after which Senate Democrats would have the opportunity to propose amendments. Instead they want to just offer the whole bill up for a vote under the budget reconciliation process, which would prevent Democrats from filibustering. Sen. Claire McCaskill (D. Missouri) roasted her Republican colleagues in a hearing, passionately accusing, “There’s a group of guys in a back room somewhere making these decisions. This is hard to take.” By the end of her remarks she was almost yelling, “Give me that opportunity. Give me an opportunity to work with you,” begging the lawmakers to stop having closed door sessions on healthcare.

That is terrifying, but there is a bit of hope from the fact that there is the possibility that Republicans don’t really want the bill they’re designing. They only have a majority of two, so they must be very sure they can get the votes. But with the 2018 election on the horizon, and politicians knowing that it will likely be a record turnout of pissed off people who want a very different government, a lot of moderates are hesitant to back what we know to be an incredibly conservative healthcare bill that is harsh to women, the LGBT community and the poor and sick (what would Jesus do, my ass).

So it’s possible that Senate Republicans just don’t want to waste more time by going through amendments to the bill they just want to have a vote for show on. Trump has reportedly told GOP lawmakers to stop wasting time on ACA reform and to move on to infrastructure and budget reform, seeing as it seems like they all have their dicks in their hands in terms of coming up with legitimate ACA reform, and Trump is anxious to get literally anything done, seeing as it’s June and his administration has accomplished little to nothing outside of reinstating back the Global Gag Rule and pulling out of the Paris agreement —which were both disgusting moves, but also easy to do, and in a way inconsequential to daily American life as we won’t see the terror those moves will cost us for years to come.

But back to the topic at hand this week, which is that for the first time maybe ever, or at least in a very long time, the American Pharmacists Association is piping in on federal drug regulations. That may sound commonplace, but it is rare that the APA actually goes so far as to band together with the National Association of Chain Drug Stores and writes a letter to the President —which is what just happened.

The letter takes serious issue with multiple legislative proposals that according to their complaint, “would allow broad personal and commercial importation of non-FDA approved prescription drugs.” The letter asks the President to not endorse the legislation, and furthermore for the Secretary of Health and Human Services to not utilize their power to “exercise the waiver authority embodied in 21 USC 384(j) that allows the Secretary to waive, in limited circumstances, the general prohibition against personal importation of prescription drugs.” It’s important to note that the current HHS Secretary is Tom Price, who was barely confirmed by Congress for having potentially unethical investments and for vocally supporting the paring down of government health programs.

Their reasoning is pretty straight forward. They explain that the new legislation would defy the Drug Supply Chain Security Act passed in 2013, which required that all prescription drugs be tracked from manufacturer to distributor. The whole intent of the DSCSA was to prevent foreign counterfeit drugs from entering U.S. markets, which seems a pretty reasonable thing to guard the American people against. Additionally, the newly confirmed FDA commissioner, Scott Gottlieb, in tandem with four former FDA commissioners published an open letter to Congress saying, “We believe that such importation represents a complex and risky approach—one that the evidence shows will not achieve the aim, and that is likely to harm patients and consumers and compromise the carefully constructed system that guards the safety of our nation’s medical products.”

One of the big concerns if the legislation were to pass is that Canada operates a network of online pharmacies, and it would be easy for any average person trying to save money on prescriptions to order from these pharmacies, and equally easy for people in other countries who are dealing in counterfeit pharmaceuticals to make their website appear to be a Canadian pharmacy. The letter explicitly warns, “People get sick and die from counterfeit medications. In the past, some consumers have been poisoned by toxic substances in counterfeit medications. In other cases, cancer patients have died because their foreign counterfeit medications contained no active ingredient. Moreover, if a foreign non-FDA approved drug is subject to a recall or is withdrawn from the market, there is no way to inform patients.”

That’s some pretty scary fucking stuff. It’s hard to understand why, with those consequences and multiple FDA commissioners, the APA, the World Health Organization and the Canadian government all speaking out against the legislation, why it would even be on the table. And now prepare to have your mind melted—the legislation was proposed by Bernie Sanders. The rational behind the proposed relaxing of drug regulations is to make healthcare more affordable. But if maybe getting poisoned or not getting the right cancer treatment are the consequences, what are we even gaining. Forbes also pointed out that importing foreign drugs would, “diminish the beneficial innovations created by the pharmaceutical industry.”

Lowering health care costs is imperative right now, but there isn’t a quick fix to a problem based on deep-seeded systemic corruption. The risks of this legislation are too high.

Photo: Jamie, CC-BY


Chloe Stillwell is a Nashville-based columnist focusing on politics, culture and feminism.

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