Political Economy of FDA, Article Review Example

In his article, Carpenter reviews what really influences the decisions and processes of the U S Food and Drug Administration. The author finds correlations that have not been uncovered before by analysts, such as media influence, and the impact of patient advocacy groups’ activities on approval times and decisions.

One of the areas that the author covered is how lobbying and regulations influence the food and drug administration just they impact politics. While pharmaceutical industry is one of the most regulated, it is also influenced by several stakeholders. Just like political parties and the Congress need to consider the long term impact of their decision, and approval of the public, media,  industry leaders, NGO-s, FDA, – one of the most respected government agencies in America – also needs to examine how its reputation will be best maintained.

The FDA has clear objectives and targets, however, the pressure of the public and media should not be neglected when making decisions. The current trend – as Carpenter explains – is that patient advocacy groups’ bargaining power has increased in the past decades. This means that Type II errors are more visible to the public through NGO and media publications than ever before. Type II errors occur when the authority rejects a new drug that should have been approved. In the late 20^th Century, the visibility of Type I errors, when the wrong drug was approved was much higher, however, in recent years this has changed. Trying to maintain its reputation, the FDA is taking time and is extra cautious about approving new treatment drugs.

One of the most important findings that Carpenter highlights in his article is media coverage and patient advocacy group representation is not in line with the severity of the illness to be treated with the new medicine. As an example, the author states that arthritis groups are simply approved faster than asthma drugs because the medical condition gets more media coverage. At the same time, the article highlights that more people die of asthma than arthritis every year, and there are more than 1.5 times as many hospitalizations related to asthma than arthritis. Still, it takes more than double the time to get an asthma drug approved than a new treatment medication for arthritis.

It seems like the better the representation of a medical condition in the media and public is the better chance it will have to get approved fast. This is a warning sign, as it creates inequality, and decisions are not plainly made based on facts and official priorities, but also political and public relation considerations. The question is: can this impact of public opinion be avoided, and does this trend make the FDA less independent and less effective? While some people, according to the article, argue that some of the processes and research should be outsourced within the FDA to speed up the drug approval process, it is likely that this would reduce the independence of the agency and give way to industry lobbying, which has been pushed back in recent years.

Reviewing the above statements, it is important to note that pressure from the public, advocacy groups, and politicians would not necessarily make the system more focused on public interest. While patient advocacy for AIDS and cancer has resulted in the speed-up of new drug approval to treat this condition, some illnesses that affect millions of people are under-represented. This means that the FDA – being influenced by politicians, the industry, and patient advocacy groups through the media becomes less fair.

Carpenter, D. “The Political Economy of FDA Drug Review: Processing, Politics and Lessons   for Policy” Health Affairs. 23 (1) pp. 52-63. 2004. Print.