Regulatory Roundup: FDA and NIH Launch New Safety Reporting Website; And More.

May 27, 2010
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA and NIH Launch New Safety Reporting Website; And More.

FDA and the National Institutes of Health launched a new website to provide a way for companies, researchers, and consumers to report pre- and postmarket safety data to the federal government. The site, called the Safety Reporting Portal (SRP),  is currently used for reporting related problems with food. Once the site is fully developed, biomedical researchers involved in human gene-transfer clinical trials will be able to use it to report adverse events. Trial sponsors can use the portal to send investigational new drug reports to the agency as well. According to a press release on the site, FDA says the portal will “ultimately enhance the government’s systematic analysis of safety information, which will benefit public health.”

FDA also announced that Simplexa Influenza A H1N1 (2009), a test for the 2009 H1N1 influenza virus in patients with signs and symptoms of respiratory infection, is okay for continued use. Previously, 2009 H1N1 swine-flu tests were only available through Emergency Use Authorizations.

Delegates from India and Thailand attending the World Health Assembly (WHA) last week submitted a draft resolution requesting that, among other things, the World Health Organization (WHO) cease work on the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) because they believe it is being used to bolster intellectual property (IP) protection. WHO created the IMPACT task force in 2006 to seek global solutions to the problem of drug counterfeiting. The two members states requested WHO to create, instead, a non-conflict-of-interest program to address quality, safety, and efficacy. They feel that the latter is a public-health issue within WHO’s jurisdiction, unlike IP rights. The proposed resolution likely stemmed from recent increases in seizures of generic drug products manufactured in the two countries (see back story, “A New Patent Battleground has Formed over India's Drug Shipments through the European Union”). The WHA working group on counterfeit medical products will make specific recommendations on the draft resolution at the 64th assembly meeting in 2011.
 
Last week, ePT reported that FDA cleared the use of Rotarix (rotavirus vaccine, live, oral) to treat rotavirus in infants. This week, the European Medicines Agency has also stated that the presence of porcine circovirus (PCV) in the vaccine poses no risk to public health, according to a press release from GlaxoSmithKline (London).