Cancer diagnosis and treatment is booming (see: What is cancer immunotherapy?) and the FDA is adapting to these changes with an organizational change. A recent article discussed a recent major organizational shift at the agency (see: Top Officials Aim To Reshape The FDA To Prepare For 'Avalanche' Of Cancer Products). Below is an excerpt from the article:
For 20 years, Richard Pazdur has run the office of the Food and Drug Administration charged with evaluating new cancer drugs, guiding the pharmaceutical industry as the business of oncology went from a relative backwater to the main event....[A]s part of the $1 billion National Cancer Moonshot effort being run by Vice President Joseph Biden, Pazdur was elevated to a new role: running a new Oncology Center of Excellence that will coordinate all of the FDA’s clinical efforts in cancer. Cancer medicines now account for 40% of the drugs under development, but the current revolution–that’s the word most doctors use–going on in cancer care doesn’t just involve drugs. Previously, Pazdur had authority over the pills and antibodies developed by companies like Roche, Merck and Bristol-Myers Squibb. But diagnostic tests, from firms like Illumina and Foundation Medicine, are likely to be just as important. And now companies like Novartis , Juno Therapeutics and Kite Pharmaceuticals are developing genetically engineered cells that hunt down and kill cancer–products that would be reviewed by yet another FDA division....
[P]harmaceutical companies, which a few years ago worried that their drug pipelines had run dry, are now filing drug applications at a dizzying pace....[N]ew technologies like DNA sequencing and 3-D printing, and there is an “avalanche” of new products coming....Not all of these new products will work. Nine in ten cancer drugs that enter human trials don’t make it to market because they are unsafe or ineffective....As with so much in drug regulation, the questions now are bureaucratic–organizational. Pazdur will be replaced as the acting head of the oncology drug division by someone who has yet to be named. The cell therapy and diagnostics divisions will still handle their own approvals. But Pazdur says he wants to share the expertise of the dozens of oncologists who work in the FDA’s drug division with those other groups. It’s not clear exactly how, and there’s no specific timeline, but he talks about thinking about it over the next month.
It's hard to totally grasp the changes that have taken place in the diagnosis and treatment of cancer in recent years. One fascinating statistic, cited in the article above, is that cancer now accounts for 40% of the drugs under development. Part of the incentive for pharmaceutical companies to develop anti-cancer drugs, obviously, is that the price of these new cancer drugs, and therefore company profits, can be overwhelming (see: 5 Freakishly Expensive Cancer Drugs). On the diagnostic side, cancer genomics is leading to scenarios unimagined a few years ago such as the definitive diagnosis of cancer with so-called liquid biopsies, avoiding surgical biopsies (see: Liquid Biopsy Predicts Colon Cancer Recurrence). Genomic analysis of cancer cells can often assess the prognosis of a lesion for the patient and avoid debilitating and unnecessary treatment. I must say that it's encouraging that the FDA is trying to keep one step ahead of all of these changes with the creation of its Oncology Center of Excellence. Obviously, all of the publicity for Vice-President Biden's "moonshot" program provided some of the impetus for these changes at the agency (see: Cancer Moonshot).