Opinions

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Feb 28, 2008

''A line between docs and drugs''

"Both the drug industry and the teaching hospitals play essential roles in modern medicine, but their functions need to be kept separate, as they will be under a policy recently unveiled by UMass Memorial Medical Center in Worcester."

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Conflicts of Interest
May 7, 2013

''The Senate Aims to Clean Up Compounding Pharmacies''

When a doctor sticks a needle in you, you expect that the drugs it carries won’t be tainted. But, possibly owing to a strange gray area in federal law, thousands of patients last October got injections for back pain that contained highly dangerous fungal meningitis, and dozens of them died. Members of the Senate Health, Education, Labor and Pensions Committee are now seeking to fix the government’s oversight of the obscure world of compounding pharmacies. The reforms they want are overdue.

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Drug Manufacturing and Distribution, Drug Safety
Apr 4, 2013

''Crackdown Needed on Specialty Pharmacies''

"The deaths and illnesses linked last fall to a New England pharmacy operating in the regulatory shadows as a cut-rate drug manufacturer is one of the biggest pharmaceutical public health disasters in American history."

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Drug Manufacturing and Distribution, Drug Safety
Jul 1, 2012

''Next steps to thwart 'superbugs'''

"An old saying goes, you don't miss your water till your well runs dry. When it comes to antibiotics, we're not only running out of water but there are no rain clouds on the horizon. The overuse and underdevelopment of these drugs have brought us close to the brink of a world without cures for deadly infections."

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Drug Manufacturing and Distribution, Antibiotic Innovation, Antibiotics in Food Animal Production
Nov 9, 2010

''FDA relies too much on tipoffs, not enough on drug checks''

"A drug-company whistle-blower last month pocketed $96 million -- her share of the money Medicare and Medicaid paid for tainted drugs. The fee is way too high -- employees will drop a dime for far less."

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Drug Manufacturing and Distribution, Drug Safety
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
Aug 14, 2010

''The Drug Safety and Accountability Act is overdue''

"The Drug Safety and Accountability Act, a bill filed today by Senator Michael Bennet (D-Colorado) is long overdue in protecting American citizens from unsafe drugs."

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Drug Manufacturing and Distribution, Drug Safety
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
Mar 23, 2012

''Editorial: Crack down on counterfeit drugs''

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

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Drug Safety
Sep 20, 2011

''Safer drug supply requires update to our regulation''

"Americans might expect their prescription drugs to be “Made in the U.S.A.,” but just like clothing or electronics, their medicine is increasingly produced in developing nations. In fact, according to a U.S. Government Accountability Office (GAO) report, at least 80 percent of the ingredients in U.S. drugs now originate overseas. This could be real cause for concern."

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Drug 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
Jun 26, 2013

''Move Forward on Medical Device Tracking''

'You may not yet depend on a pacemaker, defibrillator, stent, joint implant or any of the other life-­changing, potentially lifesaving products made by the medical device industry. But chances are you or a family member will be a patient some day.  That’s why it isn’t just the medical device industry that has a stake in the timely rollout of a long-overdue national system to better track the safety and whereabouts of devices once they’re on the market or in use."

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Drugs and Devices at the FDA
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
Nov 12, 2012

''Lawmakers face a torrent of delayed decisions''

In recent months, the White House has stalled on a host of pending rules, including implementation of the Food Safety Modernization Act.

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Food Hazards
Aug 24, 2012

''Food safety law is being delayed''

"In 2011, the president signed the Food Safety Modernization Act, the most ambitious overhaul of the nation’s food safety system since the 1930s, which passed Congress with broad bipartisan support and industry backing."

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Food Hazards