Tag Archives: Food and Drug Administration

“Sunshine: Best Rx for good medicine” by U.S. Senator Chuck Grassley

In the past few years, congressional investigations and state gift disclosure laws have raised eyebrows about these financial connections, especially where the amount that has been publicly reported is vastly less than what has actually been paid. For example, a congressional review I led from my position on the Senate Finance Committee revealed a troubling financial link between a drug maker and a child psychiatrist at Harvard, whose work led to a significant spike in diagnoses of pediatric bipolar disorders and prevalent use of antipsychotic medicines for children. Separately, an orthopedic surgeon at the University of Wisconsin received more than $19 million from a medical device company, although he reported only receiving “more than $20,000” per year on his financial disclosure records to the university.

Forest Labs settling wrongful death & personal injury lawsuits from parents of kids who took Celexa & Lexapro

Fifty-four lawsuits, mostly involving suicides and attempted suicides by teenagers in various parts of the country, accuse the New York-based pharmaceutical company of concealing a negative pediatric study on Celexa, duping physicians about the drug’s clinical trials, and targeting children in aggressive promotions of Celexa and a sister drug, Lexapro. Four of the cases were settled Friday, and two additional cases were settled in recent weeks. A surge of related settlements, which could total millions of dollars, is expected in the months ahead as the pharmaceutical company attempts to move beyond the controversy surrounding its marketing of antidepressants to children.

Big Pharma executives facing legal threat; including potential fines and prison time

Frustrated that even billion-dollar fines seem to have little effect on pharmaceutical firms, the Food and Drug Administration has increasingly signaled its intent to use a legal doctrine spawned by those long-gone rodents to bring criminal charges against top executives, even those who might have been unaware of company misdeeds. Earlier this month, Eric Blumberg, FDA litigation chief, told an industry audience that his agency was looking for cases to use what is known as the Park Doctrine as a tool to “change the corporate culture” of firms that have thus far shrugged off other penalties. Under the Park Doctrine, a corporate officer is liable for illegal corporate actions the officer should have known about or was responsible for preventing.

Big Pharma executives facing legal threat; including potential fines and prison time

Frustrated that even billion-dollar fines seem to have little effect on pharmaceutical firms, the Food and Drug Administration has increasingly signaled its intent to use a legal doctrine spawned by those long-gone rodents to bring criminal charges against top executives, even those who might have been unaware of company misdeeds. Earlier this month, Eric Blumberg, FDA litigation chief, told an industry audience that his agency was looking for cases to use what is known as the Park Doctrine as a tool to “change the corporate culture” of firms that have thus far shrugged off other penalties. Under the Park Doctrine, a corporate officer is liable for illegal corporate actions the officer should have known about or was responsible for preventing.

Booming Sales of Antipsychotic Drugs Often Fueled by Illegal Marketing Tactics

The Times reports that civil and criminal lawsuits against big pharmaceutical companies have revealed hundreds of documents showing that some company officials knew they were using questionable tactics when they marketed these powerful, expensive drugs. According to analysts and court documents, these tactics have included payments, gifts, meals and trips for doctors, biased studies, and ghostwritten medical journal articles.