Who’s to Blame for Dangerous Prescription Drugs: The FDA or Big Pharma?

(From the Ask Dr. Ruwart section in Volume 19, No. 10 of the Liberator Online. Subscribe here!)

QUESTION: The pharmaceutical company is sometimes caught pressuring the FDA to approve drugs with side effects and the FDA does so. Who is the prime mover of aggression here, the FDA or the pharmaceutical cartel?

MY SHORT ANSWER: It’s the karmic circle. The American public allowed the FDA to regulate the pharmaceutical companies under the largely erroneous assumption that they were nefarious. In the beginning, the primary loss to the American public was fewer life-saving drugs, since more money had to be spent on development instead of discovering new drugs.

The regulations reshaped the industry in a way that encouraged graft, as the regulations got more onerous. The industry “fought back” with the Prescription Drug User Fee Act which lets companies pay about $1 million for a faster review. This co-opted the regulators, since about half of their budget now comes from such fees.

In addition to losing many life-saving drugs, the drugs that we get now are less safe. The biggest safety problem with drugs on the market today is that they are meant for long-term use, which amplifies side effects. That’s because only drugs for long-term use can recover the high cost of development that regulations have produced. Even with the high prices of drugs, only 3/10 recover their costs.

This is a lose-lose situation for the American public, the industry itself (which has become close to unsustainable), and even the regulators, who will one day die or watch their loved ones die from diseases that might have been cured without regulations.

LEARN MORE: Suggested additional reading on this topic from Liberator Online editor James W. Harris:

* “Abolishing the FDA: FDA Policies Keep People Sick and Create a False Sense of Security“ by Larry Van Heerden The Freeman, March 1, 2007.

Excerpt: “The Food and Drug Administration (FDA) started out as a bulwark against snake-oil peddling. It has since swung back and forth between hostility and subservience to the drug industry. The FDA seems indifferent to the many deaths its own intransigence has caused and imperious when forced to defend its actions in court, resulting in a system that withholds life-saving drugs from the market, approves dangerous drugs, and denies everyone freedom of choice. The time has come to seriously consider abolishing the FDA.”



in Healthcare, Liberator Online Archives, Libertarian Answers on Issues, Libertarian Stances on Issues


by Mary Ruwart


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Dr. Mary Ruwart is a leading expert in libertarian communication and author of the international bestseller Healing Our World. She is also author of Short Answers to Tough Questions, in which you will find a collection of her answers from this column. In this column she provides Liberator Online readers with answers to questions libertarians are often asked.

Dr. Ruwart is a research scientist, ethicist, and a libertarian author/activist. She received her B.S. in biochemistry in 1970 and her Ph.D. in Biophysics in 1974 (both from Michigan State University). She subsequently joined the Department of Surgery at St. Louis University and left her Assistant Professorship there to accept a position with The Upjohn Company of Kalamazoo, Michigan in 1976. As a senior research scientist, Dr. Ruwart was involved in developing new therapies for a variety of diseases, including liver cirrhosis and AIDS.

Dr. Ruwart left Upjohn in 1995 to devote her time to consulting and writing. Her communications course for scientists (www.speakingforscientists.com), covering written, oral, and poster presentations has received high praise from attendees. She also provides consulting services for nutraceutical companies, clinical research organizations, and universities.

Currently, Dr. Ruwart serves as Chair of the International Society for Individual Liberty (www.isil.org) and Secretary of the Foundation for a Free Society (www.f4fs.org). She has been an At-Large member of the Libertarian National Committee (www.lp.org), served on the Board of both the Heartland Institute (www.heartland.org; Michigan Chapter) and the Fully Informed Jury Amendment Association (www.fija.org).