The U.S. Food and Drug Administration is often blamed for drug safety problems. The cause is more complex than many people think. A new study suggests third-parties like politicians interfere in the drug approval process.
It is quite fashionable to blame the FDA for any and all mishaps with "unsafe" drugs. An
article in the New England Journal of Medicine confirms that there are indeed sometimes problems. However, the underlying cause does not seem to be the often quoted conspiracy between a corrupt FDA and the evil pharmaceutical companies, but the simple fact that people who have no scientific knowledge (i.e. politicians) have been meddling in the process.
Originally, the FDA took all the time it needed to approve new drugs. If that meant people had to wait a decade or longer for their life-saving drug to be available: tough. Politicians thought that this was not acceptable and they voted the Prescription Drug User Fee Act into existence in 1992. According to this act, the FDA must act on 90% of all drug candidates within 12 months of submission or face funding cuts. As a result, many drugs are approved in the two months preceding the deadline. It is precisely these drugs that have been rushed through that are likely to be problematic later on.
It seems that the politicians have learned nothing from earlier mishaps. Until 50 years ago, most new drugs were approved within a few months after the manufacturers applied for their approval. Tragic mistakes such as the thalidomide (Softenon) scandal which led to the birth of thousands of handicapped children being born worldwide around 1960 have given birth to much stricter rules, and because of that, to massively more expensive and time-consuming testing procedures. By voting the PDUFA, the politicians essentially forced the FDA to return to pre-thalidomide terms, with all the dangers this entails.
The authors, Daniel Carpenter, professor of government in Harvard’s Faculty of Arts and Sciences, Jerry Avorn, Professor of Medicine at Harvard Medical School/chief, Division of Pharmacoepidemiology at Brigham and Women’s Hospital and Evan James Zucker, a student at Harvard Medical School, do not advocate the abandonment of current deadlines, but they do suggest that other mechanisms than strict deadlines may be indicated for an "expeditious yet rigorous drug approval".
Food for thought: while alternologists of all types love to pick on the FDA, this merely demonstrates their ignorance, or worse, their ill-will. The FDA is an organisation of humans, not all of whom are saints, but there are certainly more important causes to its apparent failing, causes that must be addressed for the urban myths that alternologists enjoy spreading about the organisation are causing a lot of harm, most of all to the people the FDA is trying to protect.
