Opinions
Opinions
| Date | Opinions | Topic |
|---|---|---|
| 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. |
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." |
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." |
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. |
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." |
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. |
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." |
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. |
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. |
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." |
Food Hazards |
