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.