• On 13 February 2009, FDA posted the final version of the Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan, available at: http://www.fda.gov/cder/pdufa/PDUFA_IV_5yr_plan_fnl.pdf.
  • On 28 January 2009, The White House released a memorandum suspending the implementation of new and pending regulations. The memo states that no proposed or final regulation should be sent to the Office of the Federal Register for publication until it has been reviewed by an Obamaappointed department or agency head. The memo also asks that officials reconsider final regulations that have been published, but have yet to take effect. A copy of the memorandum is available at: http://www.govexec.com/pdfs/012109rb1.pdf.
  • NEW FDA OFFICES On 7 January 2009 FDA opened the first Latin American office in Costa Rica (http://www.hhs.gov/news/press/2009pres/01/20090107a.html). On 15 January 2009 FDA opened offices in New Delhi, and Mumbai, India (http://www.hhs.gov/news/press/2009pres/01/20090115a.html).
  • APPOINTMENTS
  • FDA estimates that it takes between 10 and 16 hours to respond to each citizen petition: http://www.fda.gov/OHRMS/DOCKETS/98fr/oc08334.pdf
  • FDA announced an opportunity for sponsors and foreign manufacturers of finished drug products and active pharmaceutical ingredients (APIs) intended for human use imported by a secure supply chain to apply to participate in a voluntary Secure Supply Chain (SSC) pilot program to be conducted by CDER and Office of Regulatory Affairs (ORA). The goal of the pilot program is to allow FDA to determine the practicality of developing a secure supply chain program. The information obtained from this pilot program will assist FDA in its determination. A Secure Supply Chain program would assist the agency in its efforts to prevent the importation of adulterated, misbranded, or unapproved drugs by allowing the agency to focus its resources on imported drugs outside the program that may pose such risks. Such a program would increase the likelihood of expedited entry for specific finished drug products and APIs imported into the United States that meet the criteria for selection under the program. Details are available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-791.pdf. Submit comments to Docket FDA-2008-N-0656 by 16 March 2009 (http://www.regulations.gov/search/index.jsp). Press release: http://www.fda.gov/bbs/topics/NEWS/2009/NEW01943.html.
  • FDA CDER announced the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program. The Federal Register notice, available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-31320.pdf invites pharmaceutical companies interested in participating in this program to contact CDER. Pharmaceutical companies may submit proposed agendas to the agency by 6 March 2009.
  • On 22 January 2009, The US Government Accounting Office (GAO) released a report High-Risk Series: An Update, available at: http://www.gao.gov/new.items/d09271.pdf. In the updated report, GAO lists of protecting public health through enhanced oversight of medical products as a new risk. According to the report, “Concerns have been expressed about FDA's ongoing ability to fulfill its mission of ensuring the safety and efficacy of drugs, biologics, and medical devices. GAO's work examining a variety of issues at FDA echoes the conclusions reached by others that the agency is facing significant challenges that compromise its ability to protect Americans from unsafe and ineffective products. FDA needs to, among other things, improve the data it uses to manage the foreign drug inspection program, conduct more inspections of foreign establishments, systematically prioritize and track promotional materials for review, and adopt management tools to ensure that drug sponsors comply with regulations on the presentation of clinical trial results.”
  • On 15 January 2009, GAO released a report FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process, noting that FDA should expeditiously take steps to issue regulations for class III device types currently allowed to enter the market via the 510(k) process by requiring PMAs or reclassifying them to a lower class. HHS agreed with GAO’s recommendation. The report is available at: http://www.gao.gov/new.items/d09190.pdf.
  • On 15 January 2009, The U.S. Department of Health and Human Services (HHS) released two final rules that will facilitate the United States’ ongoing transition to an electronic health care environment through adoption of a new generation of diagnosis and procedure codes (http://edocket.access.gpo.gov/2009/pdf/E9-743.pdf) and updated standards for electronic health care and pharmacy transactions (http://edocket.access.gpo.gov/2009/pdf/E9-740.pdf). A fact sheet describing both rules is available at: http://www.cms.hhs.gov/apps/media/press/factsheet.asp?Counter=3407&intNumPerPage=10&checkDate=&checkKey=&srchType=1&n umDays=3500&srchOpt=0&srchData=&keywordType=All&chkNewsType=6&intPage=&showAll=&pYear=&year=&desc=&cboOrder= date.