FDA gives patent on public domain gout drug
The corruption in US regulatory agencies has reached a new milestone as the FDA gave URL Pharma the sole right to sell Colcrys (colchicine), a drug used to treat gout for thousands of years. Now the price of the drug has increased from $34.83 for 60 tablets to $306.86 for 60 tablets. This problem, exposed by CBS 60 Minutes, exemplifies the ever more urgent need for US regulatory agency reform that I wrote about in April 2010. We are heading down a road that can lead the FDA to authorize one company to sell all drinking water.
This blatant conflict of interest between a corporation and the agency supposed to regulate it has turned the FDA into a pipeline for favors to friends that turns US citizens into their unwitting slaves. Ending such conflicts of interest created by regulatory agencies can greatly reduce the cost of health care in the United States, in this case nearly 10 times. Ironically, many of the proposed “solutions” provided in Obamacare rely on creating similar agencies lacking proper checks and balances that will only increase prices and divide the spoils of such a corrupt system among a few more foxes.
URL Pharma issued a statement published with the CBS news story stating that until their research was done, improper dosages were being given causing adverse reactions. This is quite possibly true, and likely overinflated rhetoric. Regardless, the FDA violates basic conflict-of-interest principles when it provides sole right sale to a company that provides after-the-fact research on a drug in existence. The purpose of a regulatory agency is to provide independent research in order to regulate manufacturers of drugs, not to accept the rationale of the manufacturer.
A proper functioning FDA could have compiled independent data on the proper dosage of the generic drug with an algorithm that connects the amount of a doctor’s prescription to the number of people experiencing complications or side-effects in national health databases (one reason used to justify the existence of such databases). Or, the government could have provided a research grant to a university school of medicine to conduct such a study on the existing generic drug. In either case, the government could have protected its citizens from the huge financial windfall for URL Pharma at their expense. The cost of the URL Pharma research, likely to be overinflated, is expected to be repaid in less than a year, while the FDA provides them with this immoral, yet quasi-legal, monopoly intended to gouge gout sufferers and insurance companies for 17 years, raising everyone’s insurance rates in the process.
The legal foundations for this financial kickback was created through the 2002 Waxman Hatch Amendment. Ironically, the publicly stated purpose of the Waxman Hatch amendment was to increase competition in the drug market and the availability of generic drugs. However, pharmaceutical companies have managed to exploit the protections the bill provides them without producing the benefits the bill was created for. It is just another example of Congress paving the road to hell with good intentions. And, it is another example of a bill failing to pass the test of the principles of good governance outlined in my book Life, Liberty, and the Pursuit of Happiness, Version 4.0.
The passage of such bills as this amendment violates the principle of single subject legislation. Combining good and bad elements into single bills is a tactic that would cause the founding fathers to roll over in their graves, yet it has become a standard practice in virtually all bills passed by both the US Congress and state legislatures. Such legislation is usually created by lobbyists who hold out carrots to legislators of both political parties while creating legislation that inevitably serves the interests of the lobbyists at the expense of the taxpayer. It is important for citizens to learn how they are being exploited by their elected officials and the lobbyists who court them if they really want to see a broken Washington get fixed.
Today we also hear a lot of rhetoric about “public and private partnerships.” The above example of the partnership of the FDA and URL Pharma is a reason to question the motives of any politician that uses such rhetoric. It seems to be a euphemism to justify corruption. I would think twice about voting for any candidate that uses the phrase “pubic-private partnership.”
Gordon, this article is quite excellent. Actually, both copyright and patent laws need to be revisited and revised. Patenting this drug on the foundation of having discovered that less drug is needed, so that the company is actually selling smaller doses for 10x the price. Amazing.
This also drove many other producers of the drug out of the market. A small royalty payment from all the companies producing this drug could have reimbursed the company and given them a profit as well, at a much lower cost to the patient, and lesser risks to the producers and marketplace.
Yes, the purpose behind these laws is to stimulate invention and, originally, only the invention by individuals–not corporations (that is another discussion related to relative power). The idea is to reward someone for bringing something new to the economy by providing limited protection to the inventor. It was never intended to raise the price of something already on the market, making resources more scarce, and life of individuals more difficult.
Copyright is a bit different as you don’t actually copyright new ideas contained in texts, only blocks of words. Therefore if you put too high a price on a song or a book its not going to sell as there is plenty of competition among copyrighted items. However, some copyright infringement suits go too far and some clarification might be in order. We might consider putting all internet postings in the public domain.