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Congressman Edward Markey Says U.S. Drug Safety System is 'Broken' at 3rd Annual Post-Approval Summit

Posted on: Monday, 30 April 2007, 18:00 CDT

Representative Edward J. Markey (D-MA) said today that the drug safety system in the U.S. was "broken and desperately needs to be reformed."

Speaking at the third annual Post-Approval Summit at Harvard, co-presented by the Massachusetts Eye and Ear Infirmary Clinical Outcomes Research Unit and Outcome Sciences, Inc. (OUTCOME), Rep. Markey also said reauthorization of the Prescription Drug User Fee Act was a historic opportunity for reform of the Food and Drug Administration (FDA).

"Our country's Drug Safety system is broken and desperately needs to be reformed," said Rep. Markey, a senior member of the House Energy and Commerce Committee, in his keynote address. "The new Democratic majority intends to keep the spotlight shining bright on the FDA to ensure that it acts as a watchdog for the public health and not a lapdog for the pharmaceutical industry. The Waxman-Markey Enhancing Drug Safety and Innovation Act would hold the FDA to higher standards of transparency and accountability, while providing them with clear and unambiguous authority to take rapid and decisive action when necessary to ensure that the benefits of drugs always outweigh the risks."

Rep. Markey has been a Democratic member of the U. S. House of Representatives, representing the 7th District of Massachusetts, since 1977. Rep. Markey is a leading advocate for FDA's need to place greater priority on postmarketing studies and to reform the way in which they are monitored.

Rep. Markey added, "Marie Curie famously said, 'I never see what has been done; I only see what remains to be done,' so let us work together to do what needs to be done to maintain the safety and effectiveness of the medications that save lives, but also, as Hippocrates would say, do no harm. We have a historic opportunity to reform the FDA as part of the reauthorization of the Prescription Drug User Fee Act and create a more dynamic system that evolves as our knowledge about the use of drugs grows."

The Post-Approval Summit, at the Conference Center at Harvard Medical School in Boston, boasts a distinguished international line up speakers, including Barry Straube, MD, of Acting Chief Medical Officer of the Centers for Medicare and Medicaid Services (CMS); Panos Tsintis, MD, of the European Agency for the Evaluation of Medicinal Products (EMEA); Peter Littlejohns of the UK's National Institute for Healthcare and Clinical Excellence (NICE); David Atkins, MD, of the Agency for Healthcare Research and Quality (AHRQ); and Lynda Applegate of the Harvard Business School. Speakers will also include representatives of many of the world's leading pharmaceutical and biotechnology companies, including Schering-Plough, EMD Serono, Johnson & Johnson, Genzyme and Novo Nordisk.

The Post-Approval Summit has established itself as the premier forum for the discussion of strategies and best practices for demonstrating the safety, effectiveness, quality, and value of medicines and medical devices through patient registries, phase IV (post-marketing) studies, risk management programs and quality initiatives. It attracts clinical and medical officers from many of the world's most prestigious healthcare companies and regulatory bodies.

The conference agenda will cover topics including:

Evolving Landscape for Post-Approval Research

Policy and Regulatory Changes Ahead

Global Considerations

Building Effective Programs

The Role of Patient Registries

For more information about the event, visit www.postapproval.org or call 617-715-6882.

Source: Business Wire

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