Thursday, September 21, 2017

Taking $ from FDA Bad for Public Health


Sometimes I get a little weary about the laxity in standards in this country. I really wonder if there is a companyanywherewho wouldn’t do anything it takes to sell its products. Legal or illegal, moral or immoral, whatever it takes, as long they didn’t get caught.

For instance, there is a popular soda pop company that started selling its beverage in the 1800s. To insure a steady stream of customers, the company laced its drink with cocaine, which company officials knew was addicting. After addiction became epidemic, and hospital wards were swarming with newly minted cocaine addicts, the government stepped in and put a stop to the practice of drugging Americans in an attempt to get them to buy more of the company’s  soft drinks. Question: Do you think for a minute this company would not again begin the practice of lacing its beverages with cocaine if it was thought they could get away with it? And how do we know it’s not happening now? Can government agencies be trusted to periodically check the products of the beverage companies for addicting drugs. How can we be sure that a fat check sent to, say, the FDA couldn’t persuade one of its officers to turn the other way when samples of drug-laced beverages are submitted for testing?

You would likely think, Well, aren’t there rules to prevent such a practice?

The answer is, yes there are.

You might ask, Don’t American taxpayers pay the government (through taxation), which in turn pays the salaries of FDA officials to enforce the rules to protect those who eat, drink, and use medications approved by this department of the government?

You would think the answer would be an unequivocal Yes! But you would be only half right.

You see, the government pays only a part of the money that supports the FDA. Guess who pays the other part. If you said the industry that the FDA was created to oversee, you would be right.

Unbelieveable, given the sleezy reputation of the pharmaceutical companies, but absolutely true.

Since the Prescription Drug User Fee Act of 1992, which says companies seeking approval for new drugs or drug updates must fork over user fees to the FDA, the pharmaceutical companies pay half the support for the agency. Before 1992, we taxpayers paid the whole bill, which, it would seem, makes the process much safer.  Remember, the drug companies are the ones who publicly say they will finance the testing of such-and-such experimental drug, but when the results don’t support the theory, they secretly discontinue testing, rearrange the data and submit bogus results for approval. The 1992 law says forget all the expensive preparation and just submit the crapola. We’ll take care of everything. Doesn’t that make you feel safe, though?

As this report is a bit out of sync with what I usually write, perhaps an explanation is in order. The reason I bring this up (seeing as the law has been in effect for 25 years) is that, according to statnews.com  Trump budgeteers plan to reduce the FDA’s budget by one billion dollars in the 2018 budget. The plan will mean that drug companies cough up higher user fees than in the past. Big Pharma is not accustomed to losing money via reduced profits and so can be expected to recoop what they can. Higher product prices, of course, but the most disturbing aspect is the possibility of “buying” the approval of a drug that may not be ready just yet. Or ever be ready.

I don’t think reducing the funding available for the proper inspection of medicines sold to the public is a safe and proper way to save money. There must be other places from which money can be removed that isn’t so potentially deleterious to public health.

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