Newsplaining

By: 
Ethan Stoetzer

FDA bill passes the House with big compromises in the balance
     They say that a true compromise is when both sides meet at a table, and leave, having gotten nothing that they wanted; because compromising on your ideologies is hard, and usually requires a lot of catering to from either side. A bill that’s on its way to the Senate this week is a picture of a true compromise at work.
     The “21 Century Cures Act,” a $6.3 billion healthcare reform bill overhauling Food and Drug Administration regulatory policies, was passed 392-26 in the House of Representatives Wednesday. While the numbers show overwhelming support for the bill, the legalese has several catches to it, which have incited backlash from defacto liberal leaders Vermont Senator Bernie Sanders and Massachusetts Senator Elizabeth Warren. Both made similar comments that the bill was extortion of patients on behalf of pharmaceutical companies.
     Here are the facts of the bill:
     One provision will allow drug companies to use “real-world” evidence to recommend another use for a drug. Previously, if a drug company wants to test out one drug on a different condition than created for, it had to create and apply for a totally different trial and perform the same rigorous testing before sending it to the FDA.
     Coinciding with this provision, another provision would allow drug companies to only submit “summary-level reviews” on these new drug uses, meaning that the FDA wouldn’t have charts and charts of data, merely the summary of a new use for a drug, and would have to go off the company’s word for efficacy.
     On a completely different portion of the bill, federal spending on medical research for President Obama’s initiatives will increase.
     A total of $4.8 billion of 10 years will be appropriated to the National Institutes of Health (NIH) for mental health research like the Brain Research through Advancing Innovative Neurotechnologies. The research aims to create a new visualization of the brain through cells and neural circuits to better access mental health conditions. Another big program to receive this funding is Obama’s Precision Medicine Initiative, which designs patient treatment plans based on individuality, rather than one doctrine of treatment.
     The FDA will also receive $500 million over two years, while state governments will receive $1 billion over the same timeline in establishing opioid painkiller treatment plans.
     The bi-partisan builds appears to compromise on both sides of the aisle on first glance. Democrats allow for a fast track to drug approvals without much oversight, while Republicans spend over $6 billion on government programs. Both sides seem to have compromised on the things that they hold dear: regulation and government spending.
     Everything seems fair, but what’s the catch?
     The appropriation of the $6.3 billion is only applicable when the congress approves an annual appropriation amount. Next year, should the GOP controlled congress decide to shrink government expenditures, these funds will not exist. It sounds like this is a passing based on faith that allowing such loose regulations on drugs will result in government-financed research. But if history serves as a guide, $6.3 billion over 10 years should be lucky if it gets even $2 billion.
     To finance these appropriations, there would be $3.5 billion cut to public health initiatives like distributing immunizations and tobacco prevention. According to 2012 GDP data, only three percent of the output went to public health efforts.
     On the other side of the provisions, many have argued that the FDA is full of red tape and doesn’t pass any new drugs for patients, which was the basic purpose of the bill; to make the FDA efficient.
     According to two studies conducted last year by Brigham and Women’s Hospital and Harvard Medical School, the FDA is the fastest regulatory agency in the world, and is already running on compromises. An entry in the New England Journal of Medicine by Harvard Health and Policy Management Research Associate Aaron Kesselheim states that drug companies only need to do six months of a test of 760 patients to illustrate the efficacy of a drug that people will take their entire lives. In that timeframe, the FDA will take between six and 10 months to approve it.
     So while on the surface the bill appears to give and take to both sides, there are winners and losers in everything. But just who wins and who loses can’t be seen, just yet. The FDA isn’t as clunky as critics often argue; the agency is either giving someone a miracle or something that could result in death. If the FDA started approving drugs that didn’t work, one could guarantee that there’d be outrage, and regulations would be handed on a silver platter to the agency. Will these deregulations mean bad drugs? Or will it boost research? In the American drug research system, a lot of time is spent tinkering with already made drugs to keep mass marketing new prescriptions, to keep patent control. Will this really make a difference to research and development trends?
     The Senate will decide if the compromises are worth the funding and deregulations this week. It should be interesting what it does with the $6.3 billion in funding that’s tentative at best. 

Hampton Chronicle

9 Second Street NW
Hampton, IA 50441
Phone: 641-456-2585
Fax: 1-800-340-0805
Email: news@midamericapub.com

Mid-America Publishing

This newspaper is part of the Mid-America Publishing Family. Please visit www.midampublishing.com for more information.