Regulatory Roundup: FDA Releases Annual Guidance Agenda; OMB Urges Obama to Issue Revised Executive Order.

February 4, 2010
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA Releases Annual Guidance Agenda; OMB Urges Obama to Issue Revised Executive Order.

Regulatory Roundup

FDA released its annual guidance agenda. The list of draft guidances the agency plans to develop and issue in 2010 is noted on the agency website. Noteworthy are draft guidances covering comparative claims in prescription-drug promotion, direct-to-consumer advertisements, drug-product promotion using social-media tools, chemistry, manufacturing, and control (CMC) postmarketing plans, CMC postapproval changes reportable in an annual report, residual drug in transdermal drug-delivery systems, combination-drug development, pediatric-drug labeling, electronic regulatory submissions, current good manufacturing practice for highly potent compounds, and importation of active pharmaceutical ingredients for human drugs.


President Obama issued a memorandum to executive-department heads and agencies one year ago calling for a revision to the principles guiding the federal regulatory process, according to OMB Watch, a nonprofit government watchdog organization. The memo required federal agencies (including FDA) to submit recommendations for a new executive order within 100 days. Public comments were also requested. Now that the president has completed his first year in office, OMB Watch has called on Obama to complete this process by issuing a revised executive order. OMB Watch would like to see greater flexibility for agencies as well as “a more streamlined process for engaging in rulemaking and seeking White House review…. Currently, agencies are required to perform any number of analyses before writing new standards, including the notoriously unreliable cost−benefit analysis,” says the OMB Watch press release. The nonprofit noted the president’s commitment to transparency, an initiative which FDA is pursuing through its Transparency Initiative. OMB Watch's detailed recommendations for reforming the regulatory process are online, including specific recommendations for FDA.

 

According to a Jan. 29, 2010 Reutersarticle, the number of Warning Letters FDA sent in 2009 (41) was nearly double the number of letters sent in 2008 (21). Thomas Abrams, head of FDA's Division of Drug Marketing, Advertising, and Communication, told Reuters that the agency had already sent nine letters in 2010. "We're trying to get the point across to industry that we want them to comply with the law because it affects public health," he told Reuters. "If you don't comply with the law, we are going to take action."