The Generic Drug Rip Off - Letter

The Honorable:

Washington, DC

Dear:

The attached article published by the Life Extension Foundation® outlines a solution for helping to resolve today’s prescription drug cost crisis.

I urge you to introduce legislation that will enable GMP-certified manufacturing facilities to produce generic prescription drugs that do not have to undergo the excessive regulatory hurdles that force consumers to pay egregiously inflated prices for generic drugs.

The inevitable concern raised by this free market solution is safety. Who will protect consumers from poorly made generic drugs?

First of all, there would be the same regulation of these drugs as there are with GMP-certified supplement makers. FDA inspectors would visit facilities, take sample products, and assay to ensure potency of active ingredient, dissolution, etc. Laboratories that fail to make products that meet label claims would face civil and criminal penalties from the government.

Secondly, there is no incentive to not provide the full potency active ingredient in these less-regulated generic drugs. The price of the active ingredients makes up such a small percentage of the overall cost that a manufacturer would be idiotic to scrimp on potency.

Those companies who foolishly made inferior generics would be viciously exposed by the media, along with the FDA, consumer protection groups, and even prescribing physicians who would be suspicious if a drug was not working as it is supposed to.

Companies producing inferior products will be quickly driven from the marketplace as consumers who choose to purchase these lower-cost generics will seek out laboratories that have reputations for making flawless products.

Companies that produce inferior products would not only be castigated in the public’s eye, but would face civil litigation from customers who bought the defective generics. When one considers that GMP-certified manufacturing plants can cost hundreds of millions to set up, a company would be committing suicide if it failed to consistently produce generic drugs that at least met minimum standards.

I understand that no matter how many facts I list showing that these free market drugs will be safe, there are some who believe that even if one person suffers a serious adverse event because of a defective generic drug, then the law should not be amended to allow the sale of these less-regulated products.

What few understand is that enabling lower cost drugs to be sold might reduce the number of poorly made drugs. The reason is that prescription drug counterfeiting is a major issue today. Drugs are counterfeited because they are so expensive. With a month’s supply of free market simvastatin selling for only $3.20, it is difficult to imagine anyone profiting by counterfeiting it. So amending the law to enable these super-low-cost drugs to be sold might alleviate the counterfeiting that exists right now.

Another reason these less-regulated generics will do far more good than harm is that people who need them to live will be able to afford them. The media has reported on heart-wrenching stories of destitute people who cannot afford even generic prescription drugs. They either do without, or take a less-than-optimal dose. The availability of these free market generics will enable virtually anyone to be able to afford their medications.

To alert consumers when they are getting a generic whose manufacturing is not as heavily regulated as it is currently, the law should mandate that the label of these less-regulated generic drugs clearly states:

“This is not an FDA-approved manufactured generic drug and may be ineffective and potentially dangerous This drug is NOT manufactured under the same standards required for an FDA-approved generic drug. Purchase this drug at your own risk.”

The cost of prescription drugs is a significant contributing factor to today’s health care cost crisis, a problem that threatens to bankrupt consumers and this nation’s medical system. Passage of this common-sense legislation would quickly slash the cost of generic drugs so low that consumers could obtain them for less than what their co-pays currently are. This would save governmental and private health insurance programs, and ultimately consumers, enormous amounts of money.

Please don’t be influenced by pessimistic alarmists who claim that less regulation automatically means more dangerous drugs. These kinds of scare tactics have been used for decades to force Americans to pay outlandish prices for their medications. And please don’t be influenced by pharmaceutical lobbyists, who will do and say anything to protect their virtual monopoly over generic drug manufacturing.

The bottom line is that we as a nation can no longer afford to be bound by today’s inefficient regulatory system that artificially inflates the cost of our prescription medications. The money is no longer there to support this bureaucratic morass, and you know that as well as anyone.

Kindly let me know how you plan to implement this legislation that will help save this country from horrifically overpriced prescription drugs.

Sincerely,

Name:

Address: