For years I’ve been talking about the corruption of government agencies and their allegiance to the pharmaceutical industry. Now, we have a CEO of Imprimis Pharmceuticals, Inc. whining about it because it’s taking profit away from his company. So, Mark L. Baum, the CEO of the company writes an article entitled “How FDA Rules Made a $15 Drug Cost $400” to stop competition from overwhelming his company.
Before depicting his article that appeared in the Wall Street Journal on April 6, 2017, let me ask a question: How come the big food companies, the dairy industry, the meat, fish and poultry industries, the egg industry, the processed food industry, the medical profession, and big pHarma don’t tell anyone that eating a plant-based diet and taking organic sulfur crystals (sulfur used to be in the soil until the Rockefellers convinced the farmers to give up on manure and switch to petro-chemical fertilizers killing all the essential mineral sulfur in the soil) will reverse just about every illness and disease
The answer is simple: Profit!
OK, here we go with Baum’s article”
“The theory is that generic drugs should be less expensive than the original. By the time a generic hits the market, the drug’s patent has expired, allowing competition from companies that didn’t spend millions of dollars to develop it. As more options become available, prices are supposed to drop. But, because of quirks in America’s regulatory system, it doesn’t always work out that way.
In 2009 the FDA (Fraud and Drug Administration) approved a new version of Colchicine, which treats symptoms of gout ( but hey, why encourage anyone to put a lot of fiber in their diets that would push out the accumulated crap build-up in the arteries and eliminate the gout problem?). Prices rose from 25 cents to $6 per pill. Two years later, the agency approved a new hydroxyprogesterone, which helps premature births (stemming from alcohol abuse, street drugs, high blood pressure, bloating disorders, infections, etc. Gee, would diet have anything to do with that?). It went from $15 to $400 an injection.
What explains the counterintuitive price increases? All these prescription drugs fall under a category known as DESI drugs, named for their inclusion in an FDA program called Drug Efficacy Study Implementation. These drugs came to market before 1962, when the FDA approval for a drug required proving its safety but not its efficacy. Such drugs, manufactured under expired patents, are used by millions of Americans today.
But once the FDA approves a new drug application for a DESI drug, the existing drug can be pulled from the market. The “new” is treated as a material advance because it underwent testing for safety and efficacy, even though the DESI version was proved safe and effective over decades of actual use. The developer of the new drug may also get a new period of market exclusivity that lasts three years.
This makes little sense. Market exclusivity should let pharmaceutical companies recoup their often enormous investments in genuinely new drugs (In God we trust, all others pay cash!). Giving monopoly protection for what is essentially a generic version of a DESI drug merely enriches sharp-dealing companies while injuring patients (and we all know that synthetic chemicals are great for the body. LOL!)
Another reason generics often face no competition was described by Scott Gottlieb< President Trump’s nominee for FDA commissioner, in these (Wall Street Journal) pages last year. He noted that a generic-drug application can cost as much as $15 million. This high upfront cost is part of why would-be manufacturers of generics often pass on the opportunity to compete against branded drugs with smaller markets. This has allowed many pharmaceutical companies to raise priced with impunity (if you think I’m gonna give up my homes in Rumson, NJ and Beverly Hills, CA, think again).
Overhauling the drug-approval process will take time. But there are already tools to help insure reasonable prices for the estimated 17% of U.S. drugs that lack competition.
The Drug Quality and Security Act of 2013 was designed to ensure that companies can quickly respond to a drug shortage by allowing a new type of drug maker, called an “outsourcing facility”, to enter the market. It copies an FDA-approved product, regardless of exclusivity, provided that it manufactures the drug in an FDA-registered and inspected facility using FDA-approved ingredients (you know, like MSG, GMOs and glyphosate). American companies, including mine, have invested in such facilities (as well inundating TV advertising)
Yet the potential of this legislation remains untapped. The FDA should clearly define “drug shortage” to include a lack of access due to abnormally high prices. With this simple change, FDA-registered outsourcing facilities could quickly bring sky-high prices for monopoly generics with expired patents back to earth.
At the same time, the Trump administration should authorize Medicare and Medicaid to pay for compounded drugs made in outsourcing facilities, which currently aren’t covered (and then pass those costs on to the seniors and reduce their social security benefits). Right now government policy forced Medicare to pay Turing Pharmaceuticals, the brainchild of the notorious “pharma bro” Martin Shkreli $750 for a single Daraprim pill (why couldn’t it be me?). Instead, Medicare should be able to choose my Daraprim alternative, priced at 99 cents a pill, which has been safely dispensed to thousands of patients nationwide (Daraprim treats parasitic infections, which come from mostly a flesh-based diet).
Reforming the drug-approval process is critical. Meanwhile, these steps would ensure that demonstrably safe drugs (like mine) can be offered at a reasonable price to patients who need them. If drugs must carry a high price tag, it should be to recoup the investment in innovation, not to enrich a monopolist for an off-patent, inexpensive medicine it did not develop in the first place (competition should be banned)”.
And life goes on!