Executive Briefing Series (formerly The Food & Drug Letter)

The FDA has been strengthening its enforcement ever since it gained more funds and more authorities to deal more effectively with violations through the 2007 FDA Amendments Act. The most recent issue of The Food and Drug Letter revealed five trends the editors identified in analyzing warning letters issued in 2011 for good manufacturing practice (GMP) violations. This issue takes a closer look at two more trends: those the FDA issued for clinical trial violations and warning letters dealing with omission or minimization of risk in sponsor advertising and promotions.

Some industry experts have suggested that FDA’s Office of Prescription Drug Promotion (OPDP), formerly the Division of Drug Marketing, Advertising and Communications (DDMAC), has slowed down its enforcement pace via warning letters.

There are a number of measures that drug companies should consider to minimize the chances that promotional materials will draw FDA’s ire.

Onsite inspections of clinical investigators triggered by referrals experienced an upswing in 2011.