FDA Social Media Guidance Coming This MonthA
long-awaited guidance on the use of social media by FDA-regulated industry, including such popular electronic communications
platforms as Facebook and Twitter, will be available in draft form for public comment “within a month.” This
estimate was provided by special assistant to the director of CDER’s Division of Drug Marketing, Advertising, and Communications
(DDMAC), Jean-Ah Kang, who spoke 2/22 in Washington, DC at the Marketing Pharmaceuticals 2011 Conference, sponsored
by the Drug Information Association.
Although many companies have been reluctant to utilize the social media, particularly in the absence of FDA
guidance, others have begun to use these media in addition to more traditional Internet-based promotional Web sites. According
to Kang, in 2010, fully 22% of corporate submissions to DDMAC were for advertising/promotional Web sites. And, during this
same period, she said 30% of Warning and untitled letters, citing sponsors for advertising/promotion violations, were Internet-related
— indicating that Web-based communications are both of growing importance to sponsors and that they also have their
share of problems. -- READ MORE --
FDA's Regulatory Science Plan to Address Submission DeclineFDA
is banking on its regulatory science initiative to reverse a decline in new drug and biologic submissions and approvals seen
over the past few years. Addressing a Drug Information Association Webinar on regulatory science 1/28, FDA senior advisor
for science, innovation and policy Vicki Seyfert-Margolis said the agency is worried about a recent decline in submissions
from industry. New drug and biologic submissions for 2010 sank to the lowest level seen in 15 years — only 26 NDA/BLAs
submitted last year when the average over the past five years has been 32 submissions per year. And the situation is mirrored
in Europe, she said, with the EMA seeing fewer new drug applications and approvals dropping 70% to only 17 approvals compared
with 29 in 2009.-- READ MORE --
3:12 pm
FDA ‘Smoke and Mirrors’ — Obama’s Inability to Change an Agency5/14/2010 “Change” was
what drove Barack Obama into office, and his inability to materially change agencies like FDA may be what
drives him from it in 2012. The key and talented people he sent there, like most of their counterparts from prior administrations
of both parties, lacked the raw, brutish determination to avoid being captured by an agency bureaucracy that has seen so
many would-be reformers come and go. Take, for instance, the issue of regulatory enforcement. After 30 years
of a relaxed, industry-enabling and “get government off the backs of the people” Reaganesque policy that infused
the regulatory enforcement culture in Washington, where is FDA? Behind the 8-ball, say many. Apart from raising the rhetoric
and a 50% jump in Warning Letters, Obama’s team at FDA has in 18 months introduced nothing of a true “reforming”
nature for the front-line troops in the field. ... Read full report...
Woodcock Sees Big Impact from ‘Comparative Effectiveness’ Unit04/20/2010 A feature of the Administration’s recently-enacted
healthcare legislation calling for establishment of a Patient-Centered Outcomes Research Institute has received little attention
by the public, but may yet hold major implications for FDA and the pharmaceutical industry, according to CDER director Janet
Woodcock.... Read More
FDA Defends Use of OCI Agents in Employee ‘Conduct’ Probes3/26/2010 Barely three months after the Government Accountability Office faulted FDA’s oversight and management of its Office of Criminal Investigations (OCI) and Office of Internal Affairs (OIA) — and the agency’s parent
HHS agreed — FDA 3/24 staunchly defended the way those offices conduct investigations of employee misconduct. In a six-page letter to House Energy and Commerce ranking member Joe Barton (R-TX), who believes use of criminal investigators
to investigate non-criminal allegations and whistleblowers is intimidatory and bad for morale, FDA ignored the morale issue. ...Read More...
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