5 Factors Affecting Regulatory Compliance in the New Year

December 6, 2011
Ilyssa Levins

Every compliance officer knows that regulatory oversight and enforcement will continue unabated in 2012. However, here are five factors that could make the risk management challenge even greater in the New Year:

• External Forces
o Responsible Corporate Officer Liability
o Increased collaboration between FDA and OIG

• Internal Forces
o Regulatory knowledge gaps
o Disconnect between marketing and medical/regulatory/legal/compliance functions
o Untrained promotional agency vendors

By actively addressing internal forces within their control, drug and device companies can create a less vulnerable organization in the face of external regulatory compliance pressures.
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Filed Under: Pharmaceutical Advertising, Pharmaceutical Compliance, Pharmaceutical Marketing

OPDP Gets By With A Little Help From Its Friends *

November 28, 2011
Alan Minsk

It’s time to learn a new acronym. The Food and Drug Administration’s Division of Drug Marketing, Advertising, and Communications (DDMAC) is now the newly-named Office of Prescription Drug Promotion, or OPDP. DDMAC loses a letter, but gains a new name and more prominence. Elevation to an “Office” status reflects, among other things, FDA’s continued focus on prescription drug promotion and the increase in staff size. It is also noteworthy that the newly-formed OPDP contains two new divisions: the Division of Professional Promotion and the Division of Direct-to-Consumer Promotion, which recognizes some of the differences between the two types of promotions and audiences.
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