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A Risky Situation: FDA Drug Approvals at 18-Year High

The United States Food and Drug Administration (FDA) is the agency responsible for determining whether drugs are safe enough to be used in the United States. On one hand, a speedy approval process is good in that it can provide people who may otherwise die or suffer with life-changing treatments. On the other hand, speedy approval can mean approval for medications that are not actually safe which can cause serious injuries or even deaths. This dichotomy is extremely important to consider in light of the news that FDA drug approvals are at an 18-year high.

FDA Drug Approvals Reach 18-Year High

The Denver Post reports that FDA drug approvals have reached an 18-year high. The agency approved 41 first-of-a-kind drugs in 2014. This number includes a record number of approved medications for rare diseases, an outcome that is not surprising in light of the news coverage of the country’s small Ebola outbreak. Fifteen of the drugs approved this year were for what are called “orphan diseases.” These are rare conditions or disorders that affect less than 200,000 people in the whole country. Forbes Magazine reports that twelve of the approved drugs treat infectious diseases and eight treat cancer.

Why Are there More Approvals?

Without doing an in-depth analysis of each approval and denial in 2014 as compared the approvals and denials in previous years, it is impossible to say exactly why there were so many more approvals last year. However, the press is attributing it to a shift in drug industry practice. In order to increase profits, drug companies are shfiting toward creating specialty drugs for niche conditions. Why? Because these drugs have extra patent protections, a streamlined approval process, and higher price tags. In other words, they are more profitable. The costs of testing the drug and readying it for market are lower while the price to the consumer can be higher. Its a financial win-win for the drug companies.

One example of this is a treatment for a rare type of hemophilia that we reported on last year. This drug, called Obizur, could be absolutely life-saving for people suffering with Acquired Hemophilia A. But the testing of the drug may not have been as rigorous as some would like. The human trial of the drug only involved 29 adults. No safety concerns came up during the trial, but it was an extremely small trial so its entirely possible that safety issues were missed.

A Fine Line

There is a fine line between the need to approve drugs for rare conditions so that people can get life-saving treatment and the need to protect the public from unsafe and perhaps even deadly drugs. Even under regular circumstances where there is no streamlined approval process in place, dangerous drugs make it to market. Accutane, Darvon and Darvocet, Meridia, Fen-Phen (Redux), and Vioxx are just a few examples of drugs that made it to market and went on to seriously hurt or kill people. So while optimism about new treatments for rare diseases is good, it should be tempered with caution. The FDA approval process is far from flawless and we need to keep that in mind.

See Related Posts:

FDA Proposes to Shorten the Approval Process for Medical Devices

FDA Approves Treatment for Rare Type of Hemophilia