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Healthy Skepticism Library item: 16594

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Taylor L
US doctors call for tougher warnings on new drugs
The Pharma Times 2009 Sep 28
http://www.pharmatimes.com/WorldNews/article.aspx?id=16648


Full text:

Newly-approved prescription drugs should be labelled with a symbol to show that they are new, and direct-to-consumer (DTC) advertising for them should be limited for the first two years after approval, says the American College of Physicians (ACP).

This recommendation is one of six put forward by the College – the USA’s largest medical specialty organization and second-largest physician group – to improve the ability of the Food and Drug Administration (FDA) to approve and monitor new drugs.

The FDA has been chronically underfunded, and it has limited regulatory authority and insufficient organizational structure to effectively undertake the complex task of regulating the safety and effectiveness of new and approved drugs, which includes reviewing proposals for clinical trials, evaluating drug applications and proposed drug labeling and monitoring drugs once they are approved and marketed, says the ACP. The agency has taken steps to make improvements since the Institute of Medicine (IoM) reported back in 2005 that its ability to approve and monitor drug safety had been compromised by a lack of regulatory authority, long-standing underfunding, organizational problems and a lack of postmarketing data on drugs’ effectiveness and safety, but problems still remain, it adds.

“The FDA is critical in assuring the prescription drugs available in this country are safe and effective. Unfortunately, they have not historically been given the support and structure necessary to be optimally effective,” said ACP president Joseph Stubbs.

In order to effectively improve the agency’s ability to regulate drugs, the College also recommends that it should: – be given increased funding; – increase its capacity to regulate drugs manufactured outside the US through appropriations and user fees; – be granted expanded authority to exercise in the design of preapproval trials and studies; – prohibit the bundling of drugs that limits marketability and availability; and – improve the adverse events reporting system.

“Physicians and our patients expect that the medications we prescribe and use are beneficial and will not cause significant harm. I believe that using the recommendations we have provided will allow us all to be more secure in that expectation,” said Dr Stubbs.

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909