AEGiS-PRn: AIDS Healthcare Foundation Calls on FDA to Fast Track Its Oversight of Drug Advertising PRNewswireImportant note: Information in this article was accurate in 2006. The state of the art may have changed since the publication date.
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AIDS Healthcare Foundation Calls on FDA to Fast Track Its Oversight of Drug Advertising

PRNewswire - December 14, 2006


-- US' Largest AIDS Healthcare, Prevention & Education Provider Cites Critical GAO Report Faulting FDA for Laggard Response in Regulating Direct-to-Consumer Drug Ads

LOS ANGELES, Dec. 14 /PRNewswire/ -- AIDS Healthcare Foundation (AHF), the largest AIDS healthcare, prevention and education provider in the United States which operates free AIDS treatment clinics in the US, Africa, Latin America/Caribbean and Asia, including 14 healthcare centers in California and Florida, today called on the United States' Food and Drug Administration (FDA) to fast track its oversight and regulation of the multi-billion dollar business of direct-to-consumer drug advertising. AHF issued the call after a blistering Government Accountability Office (GAO) Report issued today faulted the FDA for its increasingly laggard response times in its oversight of the pharmaceutical industry's drug marketing and advertising. According to an Associated Press article from earlier today, the GAO noted:

* From 2002 through 2005, the Food and Drug Administration took four months on average to draft, approve and send warning letters and other correspondence to companies that were in violation of the rules, government auditors said.

* But from 1997 to 2001, before FDA lawyers began reviewing the letters as a matter of policy, it took just two weeks on average to issue the letters. The number of letters fell off by about half between the two time periods.

* Regulators are issuing fewer citations to drug companies for false and misleading advertisements and are taking longer to do it, a congressional report says.

* The Government Accountability Office also said the FDA lacked an effective way to screen the more than 10,000 ads and websites brought to the agency's attention each year. The amount has doubled in just four years.

"The combination of an FDA with only six reviewers scrutinizing and overseeing all U.S. drug advertising coupled with a pharmaceutical industry in search of greater and greater profits and market share for its drugs has lead to a Wild West mentality, and the Gold Rush here is clearly direct-to-consumer ads," said Michael Weinstein, President of AIDS Healthcare Foundation. "As a basic public health safeguard, we call on the FDA to immediately ramp up and fast track its regulation and oversight of the $4.2 billion direct-to-consumer drug advertising business -- hire more staff, streamline the process, just get the job done in a more timely manner to protect the public health."

AHF sent a letter to the FDA on January 10, 2006 to press the FDA to investigate Pfizer for its inappropriate DTC ads for Viagra encouraging non-medical use of the drug. As of today, it has still not received a response from the FDA to its inquiry.

SOURCE AIDS Healthcare Foundation


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