Richard Meyer FDA and drug studies

Is the FDA doing its job with follow-up clinical studies?

  • The FDA’s post-market safety monitoring program is designed to ensure that new drugs are safe.
  • A 2017 study by the Kaiser Family Foundation found that only 38% of new drugs approved by the FDA between 2009 and 2013 had any post-approval clinical studies conducted.
  • The lack of post-approval clinical studies can make it difficult to assess the long-term safety and efficacy of drugs.

It’s difficult to say definitively how many pharmaceutical companies have not conducted post-drug approval clinical studies, as no central database tracks this information. However, there is some evidence to suggest that a significant number of companies do not conduct these studies.

For example, a 2017 study by the Kaiser Family Foundation found that only 38% of new drugs approved by the FDA between 2009 and 2013 had any post-approval clinical studies conducted. The study also found that the likelihood of a drug having post-approval studies was lower for drugs approved through the FDA’s accelerated approval pathway, allowing drugs to be approved based on surrogate endpoints rather than clinical outcomes.

There are several reasons why pharmaceutical companies may not conduct post-approval clinical studies. These reasons include:

  • Cost: Post-approval clinical studies can be expensive to conduct.
  • Time: Post-approval clinical studies can take several years to complete.
  • Lack of incentive: Pharmaceutical companies may not be incentivized to conduct post-approval clinical studies if the FDA does not require them.

The lack of post-approval clinical studies can make it difficult to assess the long-term safety and efficacy of drugs. This can concern patients and healthcare providers, making it difficult to know whether a drug is safe and effective for long-term use.

Investigations suggest that, in some fields, at least one-quarter of clinical trials might be problematic or even entirely made up, warn some researchers. They urge more vital scrutiny.

In recent years, there have been calls for the FDA to require pharmaceutical companies to conduct more post-approval clinical studies. However, the FDA has been reluctant to do so, citing concerns about the cost and time involved in these studies.

It is important to note that not all pharma companies fail to conduct post-approval clinical studies. Some companies do conduct these studies, even when they are not required to do so. These companies may do so because they believe it is essential to understand their drugs’ long-term safety and efficacy.