How can we better execute postmarket drug surveillance? A recent study proposes formation of a detailed, publicly available database that could be continually updated and aggregated with new information as new clinical study results are published. This essentially...
This US Government Accountability Office’s (GAO) current report (2007) gives a brief history and overview of the 2 FDA branches – Office of New Drugs (OND), and the Office of Drug Safety (ODS) – mandated to oversee postmarketed drug safety. ...
As of 2007, the FDA has the authority to require a Risk Evaluation and Mitigation Strategy (REMS) for certain drugs and biological products, to ensure that the benefits of such products outweighed the risks. Although the FDA mandated risk-management plan applies...
Four proposals that address drug advertising and marketing issues, which have not been widely discussed, may be incorporated into the final health care reform bill. 1) Of most concern to the pharmaceutical industry is a proposal to eliminate the tax deduction for...
Allergan, the maker of Botox, is suing the federal goverment by asserting that marketing restrictions prevent the company from communicating practical medical information — like patient selection criteria or optimal dosing patterns — to doctors that could reduce the...
