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FDA Made Martin Shkreli Price Gouging Possible

FDA Made Martin Shkreli Price Gouging Possible

Martin Shkreli has become the symbol of greed in the pharmaceutical industry. Don’t blame him. He’s just doing what the government allows.

No one likes the idea of government slowing innovation, especially when it comes to things that can be a matter of life or death. However, as Americans, we don’t tend to question the procedures and bureaucracy involved in the pharmaceutical industry, unless we’re being directly harmed by it. With the increased number of states allowing the use of medical marijuana, that’s one drug that ends up being debated in the headlines, but it took a particularly greedy hedge fund manager to bring the truly negative issues involved in our pharmaceutical industry to light.

Martin Shkreli made headlines when he bought out an anti-parasitic drug, and proceeded to radically mark-up the pricing on it. This was considered particularly odious, since it is a drug that is used to treat opportunistic infections in AIDS and other immune-suppressed patients. What Americans didn’t realize was that this price gouging isn’t an international issue – it’s just in the U.S. This same drug is sold in other countries for far less, and is still used to treat AIDS and malaria patients worldwide.

The reasons for this are all within the rules and regulations of our own FDA, which are stacked on the side of people like Shkreli. He’s simply taking advantage of some rules that our government has that theoretically were created to the protect Americans from bad drugs, but have the effect of allowing corporations to protect their drugs from being manufactured for less by anyone else. It took a group of Australian students to bring this to light, and unfortunately, it probably is a headline that many Americans have missed.

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These students discovered a cheaper and safer way to make Shkreli’s drug, and have offered the procedure to the world free of charge. But, don’t expect any pharmaceutical companies in the U.S. to start using their process any time soon, because in order to do that, one of two things will need to happen. The first involves testing of the procedure, to verify that it does indeed produce the same chemical compounds as there are in Shkreli’s drug. The catch on that one is that Shkreli must consent to that testing, which he isn’t likely to do, of course. The second option involves the standard FDA approval procedures, which cost billions of dollars. That won’t happen either, because it would defeat the purpose of making the drug in a cheaper way. It would take years (decades?) for any company to recoup those costs, so the public wouldn’t end up with a less expensive option anyway.

Most people have heard complaints about the stringent and expensive procedures pharmaceutical companies must go through to bring a drug to market. While it’s obviously important to ensure the safety of Americans as much as possible, the fact is that the system really isn’t doing that anyway. If it was, we wouldn’t see the ubiquitous commercials for “bad drug” class action law suits, for one thing. We generally always knew that there were protections in place for drug companies to keep others from offering “generic” forms of their drugs for a certain period of time after an approval, and we were fine with that as well, since we knew the testing is so expensive. But, the fact that companies have managed to hold onto those special protections for much longer thanks to slight changes in the drugs, or in Shkreli’s case, the fact that they can refuse to allow anyone to test their procedures against their own drugs is unacceptable.

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Love or hate Trump, because he is a businessman, he could turn into the most likely person to actually do something about the regulatory mess that is the FDA. That is making the assumption that he views bureaucracy as a negative in all forms of business, and doesn’t like the idea of government regulations essentially creating monopolies within the pharmaceutical industry. Given his distaste for business leaving our borders, that might be the tipping point for him. For years, Americans have been travelling north to Canada for prescriptions, but now they’re also starting to travel south to Mexico for the same. When it’s down to the point where Americans are so desperate, they are taking drugs from a nation where people are warned not to drink the water, we know we’re in trouble. Hopefully Trump sees it that way, too. More importantly, here’s hoping that he sees deregulation as the only option.


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Liz Harrison
About Liz Harrison 66 Articles
Political commentator, former campaign operative, media executive, legal and medical writer, literary editor and publisher. Founder at Vigilant Liberty Radio, podcaster and radio talk-show host, and a sexual freedom activist.

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