James G. DIckinson

Most Recent Articles by James G. DIckinson

Judge blocks FDA bid to allow generic Precedex

Judge blocks FDA bid to allow generic Precedex

The US District Court for Maryland granted Hospira a temporary restraining order (TRO) against FDA, after the agency determined that potential generic competitors of the company's injectable sedation drug Precedex could be approved.

PhRMA Urges Court to Reject Off-Label Promotion Case

PhRMA Urges Court to Reject Off-Label Promotion Case

The Pharmaceutical Research and Manufacturers of America (PhRMA) says a California federal court should dismiss a whistleblower's False Claims Act suit against three drug companies on First Amendment grounds

FDA Cautions Consumers on Ebola Web Promotions

FDA Cautions Consumers on Ebola Web Promotions

FDA says that it is seeing and receiving consumer complaints about products sold online that claim to either prevent the Ebola virus or treat it.

FDA and off-label uses: a balancing act

FDA and off-label uses: a balancing act

FDA's current re-examination of its off-label promotion policies in light of the First Amendment is a delicate balancing act between its rock-solid traditional enforcement posture and a diverse new electronic communications environment.

Washington Insider: When FDA overstates its case

Washington Insider: When FDA overstates its case

What happens when it's the FDA—not a medical marketer—that is doing the overstating?

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MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.