Friday, June 1, 2012

Close the FDA’s “Loopholes” of Statism, not Freedom

Citing two recent faulty product cases, the FDA’s “top medical-device regulator said the agency needs more power to block unsafe products...” In typical fashion, a single instance or two is used to rationalize sweeping new industry-wide controls. House democrats obliged, introducing legislation to close a “loophole” and “let the FDA reject devices that have designs based on past products that were recalled for safety flaws.” AdvaMed, an industry trade group, objected that “the bill would add regulatory burdens for manufacturers who already struggle with long FDA reviews.”

The faulty products--hip replacements and vaginal implants--were made by Johnson & Johnson. Problems with the devices "sparked thousands of patient lawsuits," so the FDA wants to "prevent repeats" by acquiring more power to block what it judges to be "unsafe products" like these. 

But a handful of government bureaucrats have no right to block any products from entering the market, which already provides a remedy for customers who believe they have been harmed by faulty products--the civil court system. One of the government's proper roles is to mediate contractual disputes, which is exactly what is happening in the J&J cases. 

Courts are an objective venue for settling such disputes, and for establishing legal guidelines to govern future contractual arrangements, including product sales. In the meanwhile, the company should be free to decide whether to continue to market the product, and doctors and patients have a right to examine all of the available information and then decide whether they want to use the product.
The government has no right to interfere in whatever mutual contractual choices manufacturers, doctors, and patients make in the marketplace, based on its own concept of what constitute a "safe" product.

Indeed, the FDA’s  zeal for “safety” stymies medical entrepreneurship, with devastating results. Julie Crawshaw, citing Scott Gottlieb, a former Food and Drug Administration deputy commissioner, reports that government overregulation causes many unnecessary deaths in America.

“As evidence,” Crawshaw writes, “Gottlieb points to a tiny catheter approved and used in Europe [since 2007] to replace a deteriorated aortic in lieu of ... open-heart surgery...” An FDA advisory panel didn’t recommended approval until July 2011, Crawshaw reports, and as of October the device was still not available in the U.S. "Tens of thousands of Americans unable to travel, and too sick to undergo open-heart surgery, have died during the intervening four years." In the name of “safety,” the FDA blocks products that might be a risk, even if the patient’s alternative is death.

This case is the tip of the iceberg. About 15 years ago, as CATO noted in a report:

By a conservative estimate, FDA delays in allowing U.S. marketing of drugs used safely and effectively elsewhere around the world have cost the lives of at least 200,000 Americans over the past 30 years. That figure does not include deaths that might have been prevented by the use of drugs such as Prozac, which is associated with the decline in suicides of individuals suffering from depression. FDA regulations denying Americans timely access to new drugs have extracted a high cost in health and lives.

That's just drugs, and only up until the mid 1990s. The toll is much higher today--and potentially vastly higher in the future. Steve Forbes notes that crushing FDA regulations are crippling the development of new antibiotics at a time when drug-resistant bacterial infection is on the rise, potentially resulting a "bacterial apocalypse" the could "kill millions of us." Forbes notes:

But this play-it-safe attitude--even at the expense of human lives--is creating a devastating and potentially far more deadly impact: The pipeline for new antibiotics is drying up. Since the 1940s the miracle of penicillin and its relatives has saved tens of millions of lives. Antibiotics easily conquered such illnesses as pneumonia and tuberculosis, which routinely killed countless numbers of people each year. Bacteria, of course, can become drug-resistant, but for decades pharmaceutical companies, especially in the U.S., routinely came up with new antibiotics to fell new killer germs. Now, however, the flow of new stuff has dried to a trickle.

Yet, politicians and government bureaucrats ignore the evidence, demanding wider powers over private industry. 

But, rather than award the FDA more power to delay or block the sale of medical devices, which violates the rights of manufacturers to freely market their products, it should be stripped of that power. In its place, as Stella Daily Zawistowski explains, “the drug-monitoring equivalent of Underwriters Laboratories (UL) in electronics or A.M. Best in insurance” would arise in the private sector, and “do the job [of evaluating product safety and efficacy] far better than the FDA.” The same would be true of medical devices.

Armed with research from such private watchdog agencies, past court findings, and in consultation with their doctors and families, patients are perfectly capable of balancing risks and rewards of medical devices, and judging accordingly. More importantly, the decision is morally and rightfully theirs. A properly restructured FDA, or one folded into another government entity, can and should provide protection against, and prosecution of, any unscrupulous manufacturer who fraudulently misrepresents its product.

The house bill should be defeated. Instead, we should demand the elimination of the loopholes of statism that empowers the FDA to violate the rights of American citizens to pursue or market medical devices or other healthcare products based upon their own rational judgements.

[Related NOTE: In "Loophole": Anti-euphemism of Statism, The Objective Standard's Craig Biddle--citing an article by Jack Shafer and the observations of philosopher Ayn Rand--explained the insidious nature of today's use of the term:

"To what facts of reality does the word “loophole” refer as used by the media in this context? It denotes various means by which people are still free to act on their own judgment; it specifies aspects of life in which individual rights are not yet being thoroughly violated by the government. In other words, it names a wonderful yet rapidly diminishing thing called freedom—which users of the term “loophole” seek to smear as corrupt."]

For more, see:

Life and Liberty vs. the FDA

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