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President's jobs council report mirrors venture capitalist demands for FDA reform
Tuesday's interim report from the president's jobs council repeats venture capitalists' demands for reform of the approval process for pharmaceuticals and medical devices.
The report starts with an oft-repeated rundown of the U.S.'s declining leadership in medical innovation as Europe, China and India boost their investments in biotechnology. The report goes on to blame the "uncertain [Food and Drug Administration] regulatory environment" for the decline.
Investors want to change the drug and device approval process to make it faster and easier. Under the current system, complex clinical trials require new products to demonstrate that they're not only safe, but effective as well.
• development of a "qualitative framework for risk-benefit assessment" of new drugs and devices;
• adoption of a "more flexible benefit/risk paradigm";
• explicit consideration by the FDA of the impact of its decisions on medical innovation; and
• expansion of the FDA's Accelerated Approval pathway, which allows for faster approval of drugs and devices based on "surrogate endpoints" — such as shrinkage of a cancerous tumor — rather than real health benefits that might not be apparent for many years.
Consumer advocates, however, have raised concerns that quicker reviews could be harmful to patients.
Critics have also questioned some of the industry's data. In particular, Democrats on the House Energy and Commerce Committee during a recent hearing skewered industry-funded studies that argue medical device approval is slower and more convoluted in the U.S. than in Europe.
