FDA loophole leads to approval of defective products
If you are like most New York consumers, you probably assume that a Food and Drug Administration-approved product has been properly tested and is now considered safe. Unfortunately, that is not always the case. For example, about 90 percent of the medical products and devices that are on the market have been approved by the FDA through the agency’s 510(k) process.
But under a loophole in that process, a product that is ‘substantially equivalent’ to one that has previously been approved by the FDA must also be approved, automatically, no questions asked. Because this is the case even when that earlier product has been recalled or has otherwise been shown to be harmful, the loophole results in many defective products making their way to the market. To remedy this dangerous situation, a number of federal lawmakers are currently working to pass a law which would effectively close that loophole. Continue reading
Mix-up at pill plant could impact health of New York consumers
A pharmaceutical company has become concerned about potential product liability that may result from the mix-up of several of its prescription pain pills and over-the counter medicines. This story is worth paying attention to because the underlying facts could affect the healths of New York residents.
Novartis, the Swiss pharmaceutical company, operates a drug manufacturing plant in Nebraska. That plant was shut down last week as a result of numerous complaints that mistakes had been made with respect to several of the products made at the facility. Continue reading