Business briefs: Teva, Celgene, Komen, Apple, OPDP
The push-pull of Plan B availability continues. Although the FDA gave Teva the all-clear to make the pill available to girls 15 and up without a prescription, there's been a tussle between the US and District Judge Edward Korman of Brooklyn who said the age limit had to be removed, and the medication made available to all women regardless of age. A federal appeals court ruled Wednesday that age limits will remain in place for the two-pill version of the contraceptive, while the one-pill version will remain available to all, reports Bloomberg. Korman had previously said that the age restrictions hindered access, because it required identification that some girls and women may not have.
FDA expanded the indication of Celgene's cancer drug Revilmid to include mantle cell lymphoma for relapsed patients. The expanded use adds on to its previous indication which was for multiple myeloma. Bloomberg notes that the new use puts Revilmid in competition with Takeda's Velcade and Roche-Biogen Idec's Rituxan which are also indicated for mantle cell lymphoma.
There will be fewer Susan G Komen walks in 2014, reports the Washington Post, which says the research and awareness organization has seen participation numbers drop since the 2012 fallout over a decision that would have cut Planned Parenthood funding. This move was later reversed and accompanied by executive departures. WaPo says the foundation framed the reduced fundraising in terms of economic hardship among potential donors. This means that Washington, DC, Arizona, Boston, Chicago, Cleveland, the Tampa Bay area and San Francisco will not have the 3-day walking events in 2014. These events require walkers raise $2,300 to participate.
Apple is policing medical apps, reports MobiHealth News, which recounted the experiences of two developers who have had their applications rejected by the company. MobiHealth says the company has been scrutinizing apps that cite brand names and dosing information, telling developers they cannot do this, and that only drug makers can make apps that name-check their brands and provide dosing information. “Apple appears to be taking a more active role in determining whether a medical app is providing trustworthy information. This is a slippery slope,” MobiHealth writes, noting that it could mean hiring employees with medical expertise.
OPDP provided some insight into just what it does in the Consumer Updates section of the regulator's website. Among the facts gleaned from the Q&A with Thomas Abrams, OPDP's director: the agency receives between 6,000 and 8,000 promotional pieces a month, which are reviewed by a staff of 32 employees who are divvied up by specialty. Despite pharma's much-discussed fear of social media, Abrams says social communication is having an impact on the industry and has contributed to an increased amount of information his staff has to review.