Forest Laboratories Inc. will remain firmly grounded in primary care and continue to rely heavily on business development to broaden its portfolio as it moves beyond the Lexapro patent expiration under the leadership of CEO Brent Saunders.
Forest Cuts A New Path But Remains Rooted In Primary Care
Forest’s new CEO outlined “Project Rejuvenate,” a strategy to recharge the drug marketer, Dec. 2. The program involves headcount and cost reductions and the sale of $1 billion in debt to fund share repurchases and bolt-on acquisitions. But the plan doesn’t call for a change in strategic direction since Saunders intends to strengthen Forest’s commitment to primary care.
More from Marketing & Advertising
Results from a single-arm study cannot support representations on overall survival, progression-free survival and disease control rate for the cancer drug, the Office of Prescription Drug Promotion said in another “untitled” letter implicating the agency’s CFL guidance.
Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.
A retrospective analysis does not support a claim that multiple myeloma patients are more adherent to Hemady than generic dexamethasone, OPDP said in an "untitled" letter suggesting increased enforcement focus on promotions leveraging the agency’s 2018 CFL guidance.
Sponsors should consider the DTC ad's audio as the major statement about a prescription drug’s side effects and then choose strategically how to display the accompanying text. TV ads are now employing banners and larger text to satisfy the rule’s “dual modality” requirement.
More from Compliance
A global collaborative inspections pilot reduced the number of individual inspections for participating manufacturing facilities, demonstrating that multiple regulatory authorities can carry out joint inspections using a mix of on-site and remote approaches.
The UK’s medicines regulator is pressing on with clarifying its expectations on decentralized manufacturing of medicines.
Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.