Criticism of the FDA

The FDA has been accused of being unduly influenced by the pharmaceutical industry.

  • Does regulation cause higher drug prices?
  • Who is at fault when an unsafe product reaches the market?

The FDA has also been criticized for over- and/or under-regulating the industries it oversees.

  • Does the FDA possess excessive regulatory authority or should the FDA be given greater regulatory power, increased funding, and greater independence?

A 2016 CBS News articles reported the struggle diabetic patients face when trying to afford insulin. In the past two decades, insulin prices have skyrocketed over 700 percent, forcing many diabetic patients into a constant struggle balancing buying food, paying bills and filling their subscriptions. Some patients report that they are forced to ration their insulin, which often lead to health complications which in some cases, even lead to death. Many patients with allergies also struggle to afford epipens, as the market price only continues to grow.

Personally, I believe that regulation definitely plays a significant role in increasing drug prices. According to a 2014 study done by the RegData database, the pharmaceutical and medical manufacturing industry as approximately 10,000 more restrictions than the median U.S. industry. Such regulations come at an incredible cost- between $50 million dollars and $840 million dollars are spend preparing a drug for FDA approval, and an average of $1 billion dollars are spent during the FDA approval process. To top this, most drugs do not earn their producer profits. A study published by the Biotechnology Innovation Organization reports that only 20 percent of approved drugs cover the R&D and approval costs.

When it comes to the question of who is to blame when an unsafe product reaches the market- I would argue that it is impossible for a safe drug to reach the market in the first place. The FDA approval of a drug or device does not guarantee absolute safety, but rather, reasonable safety. If a complete lack of side effects among all patients were the FDA’s threshold of approval, no product would reach the market. Thus when a potentially unsafe drug reaches the market, no organization is actually to blame. Perhaps we could hold every organization accountable for not being more cautious, but I personally find it hard to directly say that an organization is to blame for a potentially unsafe drug in the market.

I believe that the FDA has used its regulatory power to overreach and excessively regulate in two major ways. First, the FDA uses the benefit-risk analysis on an average patient to inform its decisions regarding approval. However, the preferences of patients are appreciable different, meaning a large portion of patients will suffer for their preferences are not satisfied. This is particularly a large problem for patients that have lethal symptoms for which there is no current FDA-approved remedy. Furthermore, as we has discussed time and time again, the FDA requires drugs to be evaluated upon clinical efficacy, not its impact on the body. This requirement is the key reason why drug testing is costly and lengthy.

Perhaps it is time to consider alternate models to the current status quo. For example, one potential reform model could be granting approval authority to different certification bodies, which would compete with the FDA on the price, quality and timeliness of approval. This model already exists in the EU, where drug prices are relatively reasonable.


Categories: Clinical