It’s called a 21st century bill, but this extraordinarily dense legislative proposal follows an old, 20th century paradigm: if there’s an illness, create some new government-subsidized drugs to throw at it. The “21st Century Cures Act” is close to 400 pages long. If enacted, it would dramatically alter the ways pharmaceutical and medical device products are regulated in the US. For example, there is an expedited review and approval process for “breakthrough vaccines,” especially in the face of public health crises, but it doesn’t put important safeguards in place to protect the public, such as informed consent or post-market studies.
Health Impact News Editor Comments: Last year we covered the NBC News Dateline’s story regarding the FDA drug approval process, and their use of clinical research organizations in India that are used to conduct human trials on new drugs by major pharmaceutical companies. To test the drug approval process, NBC Dateline setup a fictitious medical company […]
by MARTHA ROSENBERG
According to Science Times, the Tuesday science section in the New York Times, scientific retractions are on the rise because of a “dysfunctional scientific climate” that has created a “winner-take-all game with perverse incentives that lead scientists to cut corners and, in some cases, commit acts of misconduct.”
But elsewhere, audacious, falsified research […]
By Jeremy Pelofsky
A U.S. Food and Drug Administration chemist was sentenced to five years in federal prison after pleading guilty to insider trading by using confidential information about drug approvals.
Cheng Yi Liang, 58, admitted buying and selling stock in more than two dozen companies with confidential FDA information to rack up just over $3.77 […]
Health Impact News Editor Comments: Dateline NBC News conducted an exhaustive investigation on the drug approval process here in the U.S. To test the drug approval process, they setup a fictitious medical company and then put together a plan to conduct drug trials on a drug that was identical to Merck’s Vioxx. Vioxx is now banned […]