Opinions

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Jul 16, 2012

''Delays and Difficulties in Assessing Metal-on-Metal Hip Implants''

More than 500,000 U.S. patients have received metal-on-metal hip prostheses, most of which were implanted between 2003 and 2010. These prostheses entered the market through the 510(k) pathway at the Food and Drug Administration (FDA), whereby manufacturers need only demonstrate substantial equivalence to a device already on the market to gain approval. Unfortunately, there is now compelling evidence that these implants fail at a higher rate than hip prostheses made of other materials.

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Drugs and Devices at the FDA
Sep 2, 2010

''Delhi's Fake Drug Whitewash''

Counterfeit drug expert Roger Bate said that a report issued by India's Central Drug Standard Control Organization this summer indicating that less than .1% of drugs sampled in the country were fakes is flawed and contradicts well-established findings by the government and scholars that suggest the number of counterfeits is much higher.

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Drug Manufacturing and Distribution, Drug Safety
Jun 26, 2012

''Disclosure can address doctors' conflicts of interest''

Pew Prescription Project Director Daniel Carlat opines in the Philadelphia Inquirer: "Monetary relationships among doctors and drug and device companies are not inherently bad; in fact, they are crucial for advancing medical research and patient care. Yet they can also skew prescribing practices and research results. That's why transparency and education are such an elegant solution: They allow these often important relationships to exist, but only on the condition that other professionals and patients are fully informed about them."

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Medical Safety
Aug 29, 2011

Distribution System OK, But it Can be Exploited

Drug distribution may involve many trading partners, which can make it difficult to determine the products’ sources or authenticity. Medicines are often bought and sold across state lines; moved in whole or partial lots; and repackaged or relabeled. These practices may be appropriate, but bad actors also may exploit vulnerabilities in this system.

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Drug Safety
Jan 3, 2010

''Drug fiends''

"One of the profound blessings in the age of modern medicine is that, when infection sets in, doctors can draw upon an array of antibiotics to knock the germs for a loop. Just imagine how it would have been for our ancestors, for whom a simple cut or bad tooth could mean "blood poisoning" and death."

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Antibiotics in Food Animal Production
Jul 3, 2012

''Drug, device reform gets bipartisan push''

"The U.S. Supreme Court's eagerly awaited Affordable Care Act ruling unfortunately overshadowed the unusually bipartisan work underway at the U.S. Capitol last week, where Congress finalized sweeping legislation crammed with smaller-scale but still vital health reforms."

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Drug Safety, Drugs and Devices at the FDA
Jan 16, 2013

''Editorial: An Unconscionable Delay''

"After two frustrating years of delay, the U.S. Food and Drug administration should soon have the power to prevent food-borne outbreaks rather than merely reacting to them."

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Food Safety
Mar 23, 2012

''Editorial: Crack down on counterfeit drugs''

Strong, national 'track and trace' system is overdue.

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Drug Safety
Jan 10, 2013

''Editorial: Late Better Than Never for New Food-Safety Rules''

"The Food and Drug Administration has proposed the most sweeping changes in food-safety rules in decades. The changes being made under the Food Safety Modernization Act, which became law in 2011, are long overdue and should be implemented as soon as possible."

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Food Safety
Jan 11, 2013

Editorial: ''New FDA Food Safety Rules Are a Huge Step Forward''

"At long last, after seven frustrating and sometimes deadly decades of inaction, the U.S. Food and Drug Administration has the power it needs to recall tainted foods and require common-sense safety measures for farmers and food manufacturers. But the new food safety rules announced last week won't do much good if there's no money to enforce them, and therein lies the rub."

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Food Safety
Nov 26, 2012

''Editorial: White House Dallies on Food-Safety Law''

''The Obama administration continues to drag its feet on a landmark consumer-protection law that could have made this week's Thanksgiving feast, leftovers and snacks considerably safer to eat.''

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Food Safety
Oct 7, 2010

''Egg Inspections: The View From the F.D.A.''

"Contrary to your article, Food and Drug Administration inspections of the egg industry are on track."

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Food Safety
Jan 8, 2009

''End misuse of antibiotics''

"While your editorial ('Delmarva travel warning,' Tuesday) made light of the dangers of driving behind trucks transporting intensively raised chickens..."

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Antibiotics in Food Animal Production
May 19, 2012

''Eric J. Greene: Landmark food law in political limbo?''

"When President Barack Obama last year signed a bill hailed as a milestone in food safety, he stood at an exceedingly rare intersection where persuasive majorities of businesses, policymakers and consumers wanted the same thing."

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Food Hazards
Jan 10, 2012

''F.D.A. Creeps Forward''

"Last week, the Food and Drug Administration took a small step toward reducing the routine use of antibiotics in livestock, a practice that creates drug-resistant pathogens and threatens the effectiveness of some antibiotics in human medicine."

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Antibiotics in Food Animal Production