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Needed: safer drugs and medical devices.(safety laws )
It is long past time for Congress to strengthen our nation's safety laws regarding drugs and medical devices.
Over the past two years, numerous deaths and injuries have been linked to certain prescription medications and medical devices. Common to these cases is the fact that the manufacturers--and the Food and Drug Administration, which approved the products--downplayed a problem or kept it from the public for months or years.
Some drugs carry risks that should have been detected and publicized earlier (see "Prescription for Trouble," page 34). In some cases, the drugmaker withheld safety risks from the public.
Consumers face unnecessary risks because of weak laws and a seeming lack of will by FDA leadership to challenge the pharmaceutical industry. Critics both inside and outside the agency say the emphasis has shifted in recent years to approving drugs--in some cases new therapies,but mostly "me too" drugs that mimic ones already being sold--at the expense of safety monitoring once they are on the market.
Flaws in the drug-safety system were dramatically exposed in 2004, when the arthritis pain medication Vioxx was removed from the market. An estimated 139,000 heart attacks, strokes, and other serious complications had been linked to the drug, which was heavily marketed by Merck even though the company and the FDA had known of the safety risks since 2000, when the first study of the drug raised concerns.
Similarly, GlaxoSmithKline, maker of the antidepressant Paxil, had studies dating back to 1998 showing an increased risk of suicide in children and teenagers. GSK never published that information. It was not until October 2004 that the FDA at last required the strongest safety warning on Paxil and other antidepressants.
Little has been done to prevent such problems.The ...
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...approval of new medical devices. As Congress...Administration (FDA), patients...died." The FDA already takes...breakthrough medical devices as is allowed...improvement at the FDA." American manufacturers of medical devices say the unnecessary...
- Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections.
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...Drug Administration: FDA to Review Medical Devices Marketed Prior to 1976...That law authorized the FDA to review new medical devices. Today's announcement...report to Congress. The FDA classifies medical devices into three categories...
- Medical Devices: FDA Faces Challenges in Conducting Inspections of Foreign...
- General Accounting Office Reports & Testimony June 1, 2008 700+ words
...Administration's (FDA) oversight of the...effectiveness of medical devices marketed in the...GAO assesses (1) FDA's program for...that manufacture medical devices for the U.S. market and (2) FDA's programs for...
- FDA crackdown on medical devices is headache for firms. (Federal and Drug...
- Magazine article from: Boston Business Journal Hower, Wendy May 18, 1992 700+ words
...recent crackdown on medical devices will soon be like...congressional pressure, the FDA is scrutinizing...Dow Jones Advanced Medical Devices Group by more than...in Boston. The FDA review process...treatment will help the FDA decide whether a...factory to build medical ...
- FDA's Lutter: nanotech changing how medical devices are made.
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...recommendation for guidances FDA's Lutter: nanotech changing how medical devices are made By AMANDA...Staff Writer The FDA's nanotechnology...acknowledging that FDA is behind the nanotech...medical materials and medical devices are made," "The...
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...the effort to provide FDA approved generic medical devices to a cost-conscious...Board Member at Generic Medical Devices. "We are excited to continue working with the FDA to introduce new, generic medical devices that meet the highest...
- FDA Requests Recall of All Shelhigh Medical Devices.
- Press release article from: M2 Presswire May 3, 2007 700+ words
M2 PRESSWIRE-3 May 2007-US FDA: FDA Requests Recall of All Shelhigh Medical Devices(C)1994-2007 M2 COMMUNICATIONS...2007, U.S. Marshals, at FDA's request, seized all medical devices including components at Shelhigh...