At a fundamental level, the regulation of healthcare products is about trust. Every time a drug, device, biologic or other product is prescribed by a doctor, dispensed by a pharmacist or taken by a patient, they do so with the basic understanding that a product is more likely than not to help alleviate symptoms or suffering. While this doesn't seem like much, it's a far cry from the days of old when the trust one had in a product was based on faith or its marketing. No...

Trust is the foundation of many good relationships, but as a new Warning Letter to a dietary supplement manufacturer illustrates, it's not the foundation of a good manufacturing practices (GMP) system. The 15 April 2013 letter to Irenda Corporation of Los Angeles, CA, references a September 2012 inspection during which FDA inspectors reportedly found "significant violations" of current GMP regulations for dietary supplements under 21 CFR 111. The reported violations we...

Americans don't particularly trust the pharmaceutical industry. But the extent to which that trust deficit exists is on particularly glaring display in a new survey, which shows that more than one in seven Americans think the pharmaceutical industry is colluding to "invent" new diseases in order to profit off them, and 20% erroneously think vaccines cause autism. Survey Results The survey, conducted by the group Public Policy Polling, approached 1,247 registered voters,...

The California Supreme Court is set to review a case on so-called 'pay for delay' settlements that see pharmaceutical manufacturers pay generic manufacturers to secure additional months of market exclusivity for their products. The court will review a decade-old class-action lawsuit against Bayer over its pay for delay settlement to Barr Laboratories. Barr was reportedly planning to sell a generic version of Bayer's antibiotic, Cipro (ciprofloxacin). The lawsuit alleges...