Saturday, October 22, 2011

Genetic Engineering & Biotechnology News: 'Can the FDA Be a Catalyst for Innovation?'

Quoting Colorado's Dr. Tim Rodell (GlobeImmune) and Holli Riebel (CBSA) from the October 15 GEN:

"The products the FDA regulates represent 20% to 25% of every consumer dollar spent in the U.S., Dr. Hamburg pointed out. 'That’s a gigantic percent of the country’s gross domestic product,' Tim Rodell, M.D., CEO of GlobeImmune ( and a member of the BIO board of directors, said. 'Given the FDA’s importance, it warrants being a cabinet-level agency.'

...Although FDA reviewers typically are trained in scientific research, applying that experience to the regulatory environment is learned on the job. 'That’s a significant deficit for the agency,' Dr. Rodell said. 'There’s no process to train the kinds of people the FDA needs.' Consequently, 'it takes one to two years for new reviewers to get up and running.'

Meanwhile, the FDA, in its determination to do no harm, risks being so cautious that it withholds live-saving therapies. Admittedly, it’s a delicate balance. 'Innovation occurs so quickly that FDA staff can’t keep up with new technology,' observed Holli Riebel, president and CEO of Colorado BioScience.

'Patients are waiting and—sometimes—dying, while amazing drugs aren’t released because of fears about potentially adverse reactions. Science isn’t perfect. We can’t push forward without some risks.'

...BIO also supports a progressive approval pathway so that even before final trials are completed, promising therapeutics could be released and monitored. Dr. Rodell suggested that could be accomplished safely and effectively by designing electronic medical records systems to accommodate retrospective, anonymous analysis of drug safety in real time. Therefore, drug developers could track adverse events associated with the commercial release of particular therapies more accurately than under the current system, which depends upon harried physicians taking the time to voluntarily report adverse events. Dr. Rodell added that the FDA is exploring this already with its pilot Sentinel initiative.

Link to the article at the GEN website

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