Where will the money go? Well, the agency says it will significantly expand its postmarketing safety activities, adopting new scientific approaches to drug safety to meet its commitments under the Prescription Drug User Fee Act, FDA News reports.
The agency plans to spend fees to fund epidemiology “best practices” and data acquisition ($7 million in [...]

Several years ago, Emory University psychiatry and radiology professor Doug Bremner was immersed in a long-running controversy over Accutane and links to suicide. His research vexed the drugmaker, Roche, and he wound up as an expert witness in litigation. The experience and subsequent scandals about undisclosed side effects prompted him to write a book, “Before [...]

Five officials from a Chinese pharmaceutical company that sold a tainted antibiotic responsible for more than a dozen deaths have been sentenced to up to seven years in prison, the Associated Press reports, citing Chinese media.
The court convicted the five of being responsible for the deaths of 13 patients due to a lack of safety [...]

The so-called Discussion Draft is meant to stimulate chatter about how to provide adequate funding and authority for FDA to ensure the safety of the nation’s food, drug, medical device, and cosmetic supply, according to the House Energy and Commerce Committee, which intends to hold hearings over the next few weeks and to markup legislation [...]

The big health insurer wants a system in place that will use its 35 million-member database to monitor and help to more quickly identify potential safety problems of approved drugs. The Safety Sentinel System, which is being developed in collaboration with the FDA and other government and academic institutions, should in theory be able to [...]

That’s the concern after the government moved yesterday to meet intense pressure to get new drugs on the market faster while maintaining rigorous safety requirements. But health experts warned that Canadians could be exposed to meds that are approved too quickly to ensure safety, The Globe and Mail reports.
Canada introduced sweeping changes to the way [...]

The FDA plans to spend user fees to hire more safety evaluators, epidemiologists, regulatory project managers and experts in risk management and medication errors to enhance their postmarket drug-safety activities, according to FDA News. The details are spelled out in a draft called ‘PDUFA IV Drug-Safety Five-Year Plan.’
The agency add risk-management experts responsible for reviewing [...]

The Prescription Drug and User Fee Act is regularly blamed for pushing the FDA to rush approvals and causing unanticipated safety problems. And so researchers examined outcomes for drugs approved two months prior to their PDUFA dates and those approved at other times and guess what they found? The PDUFA system led to more recalls [...]

It’s about time, yes? A non-profit group, the iHealth Alliance, is launching an online network that will send e-mail alerts to docs. Of course, the docs have to sign up. The move comes two years after the FDA issued a guidance that attempted to update the equivalent of a pigeon-carrier system, although many drugmakers still [...]

A new poll finds Americans greatly value the potential benefits of prescription drugs for their families, but most believe they cost too much money and many struggle to pay for needed meds. A campaign issue, perhaps?
Four in 10 Americans (and half of those regularly taking at least one medication) report experiencing at least one of [...]