FDA crackdown on Genzyme

US legislators propose crackdown on toxic cosmetics.

cosmetics regulation, American legislators are proposing that the United States Food and Drug Administration (FDA) be given the authority to ensure that personal-care products, including cosmetics, are free of harmful ingredients and that their labels fully disclose all components. The proposed “Safe Cosmetics Act of 2011” would give FDA the authority to demand safety assessments of cosmetics i...

Prescribing opioids during the diversion crackdown.

291 participating. Investigative tactics include offering arrested patients the opportunity to serve as confidential informants, covertly interviewing physicians’ current or former employees, and scheduling appointments with physicians to seek prescriptions for opioids, often secretly recording office visits. Successfully responding to investigations requires physicians to demonstrate proactive...

Taking on Big Pharma and the FDA

Our American system of drug regulation is heavily frontloaded. The FDA spends a lot of time and energy (though not always enough) evaluating a proposed drug's safety and efficacy before approving it. But this initial evaluation is inherently constrained by the limited data available from clinical trials conducted before the product enters the marketplace. Ultimately, the FDA makes a judgment ba...

FDA perspective on anti-TNF treatments.

Although there are many points I would like to make about the FDA’s perspective on antiTNF treatments, I have limited myself to those 10 that I believe are most important. I present several of these less as absolutes than as stimulants for discussion, as I wish to make use of the expertise at this conference for furthering our collective understanding of how anti-TNF agents might best be used.

Disclaimers of Wrongful Discharge Liability: Time for a Crackdown?