According to a press release from Rx Compliance Report (subscription req'd), here are some of the top enforcment trends for pharma in the coming year:
I. Scrutiny of drug marketing by state and federal prosecutors has yet to peak. "The pressure on the industry
continues to mount. The spotlight continues, to this day, to grow brighter and
brighter," says Paul Kalb, Chair, Health Law Practice, Sidley Austin Brown &
2. Medical device sector will face dramatically increased scrutiny. "Medical device companies will begin to face real scrutiny, like their
pharma counterparts have endured in the last few years," predicts former OIG Sr
Counsel Ted Acosta.
3. Small pharma will become a growing target.
"Small pharma companies often make better targets, even though they do not have
deep pockets," says Paul DeMuro, partner, Latham & Watkins.
Off-label promotion investigations will continue unabated. "Off label issues
will continue to explode," warns Bill Sarraille, Partner, Sidley Austin Brown
5. Drug safety investigations will overlap with investigations into promotion. "Congressional investigations into drug safety
will branch out into illegal marketing practices that promoted the unsafe
drugs," predicts Mark Kleiman, qui tam attorney.
6. Continuing medical education will rebound in 2005. "Accredited Continuing Medical Education
will survive threats from the HHS OIG and missteps from the ACCME in 2004, and
emerge even stronger by late 2005," says John Kamp, Exec Dir, Coalition for
7. Pharma will increasingly voluntarily curb DTC advertising. "In the face of continuing controversy over the role of
DTC advertising, industry groups will agree to more vigorous self-regulatory
measures," says Wayne Pines, President Of Regulatory Services & Healthcare,
8. New California law will continue to stymie pharma companies. "The California law will continue to be a real challenge for
pharmaceutical companies," predicts former acting HHS Inspector General Dana