Leading the News #ebola

Leading the News

FDA Shortens Review Period For Ebola Medicines.

The National Journal (10/17, Koren, Subscription Publication) reports that “the Food and Drug Administration is in crisis mode, and its process of reviewing applications for new drugs has been pushed into overdrive” as a result of the Ebola crisis. The FDA is now “reviewing new drug applications to fight Ebola in a matter of days instead of months or years.”

        Roche Considers Getting Approval For Ebola Test. The Wall Street Journal (10/17, Morse, Subscription Publication) reports that Roche Holding AG, a Swiss company, in considering submitting an Ebola test it has developed for emergency use approval. The company has already filed for approval from European Regulators. The company did not specify when it would officially file with the FDA.

        Meanwhile, The Wall Street Journal (10/17, Loftus, Subscription Publication) reports North Carolina-based Chimerix Inc. will begin clinical trials for its Ebola drug brincidofovir after receiving authorization from the FDA.

        HHS Fast-Tracking Development Of Third Ebola Vaccine. The Hill (10/17, Kamisar) reports that, according to a press release, “The Department of Health and Human Services will fast-track the development of a third Ebola vaccine that had a 100 percent success rate with non-human primates.” Robin Robinson, the director of the agency’s Biomedical Advanced Research and Development Authority, stated, “We are pushing hard to advance the development of multiple products as quickly as possible for clinical evaluation and future use in preventing or treating this deadly disease.”

        The Baltimore Sun (10/17) reports that HHS “is giving $5.8 million to Baltimore company Profectus BioSciences for its efforts to develop an Ebola vaccine.” Profectus is preparing “to apply to the Food and Drug Administration to begin human clinical trials,” and “the money from HHS’s Biomedical Advanced Research and Development Authority will go toward manufacturing a vaccine for those trials.” Modern Healthcare (10/17, Frank, Subscription Publication) also covers the story.

        Opinion: FDA Using 19th Century Science. Robert Goldberg, vice president of the Center for Medicine in the Public Interest, writes in a New York Post (10/17) op-ed that there are several companies that “could start producing Ebola vaccine/treatments tomorrow – except that the Food and Drug Administration’s insistence on randomized studies and endless demands for more data means firms have to spend millions on paperwork instead of producing medicines.” As a result, Goldberg says, many companies now don’t even attempt to develop a vaccine. He concludes that the FDA “is using 19th-century science to decide which medical technologies should be used in the 21st century.”