FDA still under fire

By Dr Matt Wilkinson

- Last updated on GMT

Related tags: Food and drug administration, Fda

The US Food and Drug Administration (FDA) has been coming under
increased scrutiny over its approval process and funding mechanism.

Later this year, Congress will consider whether to allow the FDA to continue to collect fees from pharmaceutical companies to help pay for the drug approval process. Critics of the scheme say that industry fees lead to a corrupting influence putting products before American consumer's wellbeing. At the beginning of the month the Bush administration called for an increase in the FDA budget of $100m (€76m) to $2.1bn. The total budget includes nearly $444m in industry fees with plans to charge generic drug makers nearly $16m to review their new product applications. The Prescription Drug Users Fee Acts (PDUFA) have given the FDA the opportunity to hire more staff due to increased funding, leading to a decrease in drug approval times. This has led to a perceived drug safety crisis due to industry fees seeming to exert undue industry influence over the approval process. "The notion that you can come up with a new drug and have millions and millions of people take it safely is what got us in trouble,"​ said David Kessler, who was the FDA commissioner from 1990 to 1997. The Consumers Union said the budget increase just about equals inflation and does not include the large expansion called for by a recent Institute of Medicine (IOM) report that found that a lack of money and staff hamper the FDA's ability to properly monitor drug safety and protect the public. The IOM report said: "the FDA's credibility is its most crucial asset, and recent concerns about the independence of advisory committee members . . . have cast a shadow on the trustworthiness of the scientific advice received by the agency." ​ The report called for the reevaluation of drug safety and effectiveness within five years of approval with the agency needing new authority to impose fines and requirements on the pharmaceutical industry. A recent editorial in 'Health Economics'​ claims that no product application would pass the FDA approval process with the quality and type of evidence that currently exist for evaluating the FDA policies themselves. The article also claims that the IOM report presents little evidence of the perceived drug safety crisis in the US. The article also criticises the report's documentation of the decreased approval times attributed to the PDUFA, with no discussion about whether the approvals were rushed or have compromised the safety and wellbeing of consumers. However, the lead author of the article, Professor Tomas Philipson of the University of Chicago, has previously found that the social benefit generated by reductions in drug approval times substantially outweighs any decreases in safety associated with more rapid approval. Professor Philipson estimates that the gains to society from reduced approval times amount to between $16bn and $32bn, or 180,000 to 310,000 life years for 662 new drugs approved from 1979 to 2002. If all drug withdrawals were due to lapses caused by more rapid approval the number of life years lost would be 58,000 over the same time period. Professor Philipson does agree with the IOM report on several issues, including the fact that the current focus on pre-market drug safety and efficacy testing should be coupled with equally vigilant post-market studies. He claims that: "the science of approval is far more elaborate than the science of withdrawal, many times done under great political pressure.""Furthermore, there is a clear need for stronger FDA commitments to post-approval studies, since pharmaceutical companies have little incentive to engage in such studies as they can only lower profits." ​ Professor Philipson, does however question the validity of the IOM's claims that the 'regulatory capture' of the FDA by pharmaceutical companies has had negative social effects. He refers to a recent study by the Public Citizen's Health Research Group, which suggests that conflicts of interest, argued to be an important drawback of the PDUFA, have played little or no role in approval decisions made by the FDA.

Related topics: Preclinical Research

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