Time to do away with the FDA
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For individuals suffering from hepatitis C, a blood-borne virus causing liver inflammation, life can be difficult. For 70-85 percent of those with the virus, the condition is chronic, with effects ranging from liver infection to cirrhosis to death.  

The nearly 3.2 million Americans suffering from this illness received hope in 2014 with the release of a new drug, Sovaldi. The medicine is nothing short of a godsend for patients. While older treatments are long and not very effective and have a variety of nasty side effects, 90 percent of people taking Sovaldi can expect to be cured in as little as 12 weeks.  

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The catch? Each pill costs $1,000. A typical course of treatment runs about $84,000. 

People have been quick to point out that the price of the drug is prohibitively expensive for many individuals, especially those without adequate medical insurance.  

However, before we go pointing the finger at “capitalistic greed,” it’s important to ask some additional questions. Why is only one company allowed to make this product? Why have other competitors not come to the market with cheaper alternatives?  

The culprit isn’t capitalism; it’s government, in particular, the Food and Drug Administration (FDA).

The FDA ensures that medicines are “safe,” but the process is agonizingly slow. Currently it takes years to bring new drugs to market. One study found that from 1938 to 2014 the FDA approved only a fraction of the drugs submitted. More important, many approvals were given to but a few companies, namely, Merck, Roche, Johnson & Johnson, Eli Lilly, and Pfizer. 

This process generates three important effects. First, it effectively grants a government-protected monopoly to those companies. The FDA approval process is so expensive that many smaller companies without the necessary financial resources are prevented from competing. By preventing competitors from coming onto the market, the FDA eliminates the market forces that preclude monopolies. The results are higher prices and fewer drugs, that is, fewer options for patients. For hepatitis patients facing a $1,000 pill, this may literally be a life-and-death issue.  

Second, the FDA-approval process can increase drug costs by hundreds, even thousands of dollars. Take Provenge, a prostate-cancer drug. Despite its proven efficacy, FDA mandates have prevented it from going on the market for a full eight years. Researchers estimate that as a result of this delay, patients lost a total of 82,000 years of life. The multiple clinical trials required by the FDA to bring the drug to market meant that the drugmaker needed to increase the price substantially to cover its losses. When the drug was finally released, the therapy cost some $93,000.

The third problem is perhaps counterintuitive. The FDA is said to be necessary to keep unsafe and ineffective drugs off the market because doctors, swayed by pharmaceutical reps or lacking proper information, would prescribe dangerous drugs or worthless to their patients. Actually, in a free market, drug companies and doctors would face strong incentives to make and prescribe medicines that are both effective and safe. If a company manufactured an ineffective drug, it would quickly lose customers in a competitive marketplace. Similarly, if a company created unsafe drugs, it would not only lose customers but would likely be sued. In the same way, a doctor looking to maintain his reputation and practice would face strong free-market incentives to prescribe only safe and effective medicines.  

In contrast, FDA regulations encourage both doctors and patients to get lazy about their care. If the FDA is presumed to vouch for the safety of drugs, patients and doctors have less incentive to be concerned about safety themselves. However, the FDA’s track record gives us scant grounds for confidence in the safety of drugs. Between 2004 and 2014 the FDA recalled more than 4,200 medicines. Some 362 were Class I recalls, meaning exposure to drugs could cause serious health consequences and even death.  

It’s time to rethink the FDA. While regulating drugs for the sake of the public may sound appealing, it arguably does more harm than good. Ultimately, the FDA increases prices to consumers, slows the production of life-saving drugs, and is alarmingly ineffective.

Hall is an Independent Institute Research fellow (Independent.org) and an assistant professor of Economics at the University of Tampa.