Healthy Skepticism Library item: 17653
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 FDA 'must test new drugs against current therapies, not placebo'
Pharma Times 2010 April 19
http://www.pharmatimes.com/WorldNews/article.aspx?id=17716
Full text:
The US Food and Drug Administration (FDA) has been told to test new drugs against currently-available treatments rather than placebo.
“It is past time to transition to a new system in which drugs and devices are tested against the currently-approved best practice,” William Vaughan, health policy analyst at Consumers’ Union (CU), told a public meeting conducted by the FDA last week as the first step in what is expected to be at least a two-year process of reauthorising the Prescription Drug User Fee Act (PDUFA) programme.
PDUFA authorizes user fees for FDA product reviews – currently funding 65% of new drug review costs – and was first enacted in 1992. It has been reauthorized three times, most recently in September 2007. The current version, PDUFA IV, expires in September 2012.
The FDA held the meeting before its begins discussions with industry in June on the Act’s reauthorization, in order to gather views on what changes should be made to the current legislation before Congress votes on PDUFA V, it is hoped in early 2012.
Speakers at the meeting were generally positive about the effects of PDUFA, telling agency officials that user fees have reduced product review times from an average of three years 20 years ago to just eighteen months, have enabled the FDA to increase the numbers of its full-time review staff from 1,277 in 1992 to nearly 3,000 in 1992 and have saved as many 310,000 lives by speeding the market entry of new medicines.
However, collecting user fees from the makers of the products it regulates “undermines public confidence in the FDA and creates the perception that the FDA is beholden to the industry it regulates,” warned Andrew Emmett, director of scientific and regulatory affairs at the Biotechnology Industry Organization (BIO). Other speakers also stressed that industry should not be the sole source of funding for the agency’s product review functions.
Diana Zuckerman, president of the National Research Center for Women & Families, called on the agency to utilize industry fees to employ more staff so that direct-to-consumer (DTC) advertising of drugs on television, in the print media and on-line can be reviewed “in a timely manner,” and preferably before the ads appear.
Mr Vaughan also suggested that drug labels should be made clearer, with comprehensive listing of the product’s risks and benefits.
The Pharmaceutical Research and Manufacturers of America (PhRMA) believes PDUFA has been “a success for patients and for the public health,” said the group’s senior vice president for scientific and regulatory affairs, David Wheadon. However, he added that PhRMA was “heartened that FDA leadership has embraced the need to advocate for an empowered agency that is fully funded through enhanced Congressional appropriations.”
Dr Wheadon noted the agency’s acknowledgement of recent setbacks in its ability to review New Drug Applications in a timely manner, pointing out that “it is essential that new drug reviews be accomplished in a way that is efficient, predictable and well-coordinated within FDA,” and adding that the industry group is “encouraged by recent statements by FDA leaders that the agency intends to improve its performance to align with review goals established under PDUFA.”
“Public health and safety are best served by a science-based balance between the need for quality, timely reviews and rigorous pre-market and post-market surveillance. Through its history, PDUFA has allowed the FDA to move closer to the appropriate balance, which is why we vigorously endorse a reauthorization of PDUFA in 2012,” said Dr Wheadon.
FDA officials say they plan to complete their negotiations with the regulated industries by next January, to have a proposal ready for public review by November 2011 and to send a final version to Congress for a vote in early 2012.
The FDA roposes to use funding from the reauthorization to tackle drug regulatory challenges, particularly the monitoring of products manufactured overseas, noted Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER). “I would say we still don’t have a sophisticated drug safety system, but we’re on the way to building one,” she commented.
