Compliance Resources to Help you Stay Current

The US FDA recently held a 2-day public hearing to seek input for more flexible regulations on off-label promotion for drugs and devices. Pharmaceutical, medical device, and insurance industries, health and safety advocates, as well as physicians and patients packed a room for two full days at the FDA’s campus to debate on these rules and regulations.

Dr. Robert Califf, the FDA commissioner, said that ultimately, the analysis of the regulations is to ensure that the system "best protects and promotes the public health and the well-being of patients."

Pharmaceutical companies stated that current marketing regulations are too restrictive.

Patients argued that relaxing these regulations would be a "public health disaster."

Caught in the Marketing Melee: Inbound vs. Outbound

Out with the old, in with the new. This mantra never really rang true with marketing. Older marketing techniques continue to hold their place, while making room for newer platforms and strategies. The playground is fairly level now. But which side are you on?

The FDA, which regulates dietary supplement products and their ingredients, recently warned manufacturers of dietary supplements containing DMAA (1, 3-dimethylamylamine) for not providing evidence regarding safety of their products. The Agency thus deemed the products as 'adulterated' (as DMAA is known to cause serious side-effects) and sent warning letters to 10 manufacturing firms for failing to demonstrate the safety of their products.

Non-prescription (OTC) drugs marketed without an approved application are also subject to adverse event reporting requirements, under section 760 of the Federal Food, Drug, and Cosmetic Act. A report of each adverse drug experience which is both serious and unexpected must be made to the Agency, as soon as possible, but no later than 15 days, after receiving information about the event.