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Oct 18, 2011

FDA Regulations Can Do as Much Harm as Good, According to GEN Poll

  • A majority of respondents to a Genetic Engineering & Biotechnology News (GEN) poll believe the FDA does not always act as a positive force. The GEN poll asked: “Do FDA regulations do as much harm as good?” The results: 48.7% replied yes, 38.7 % said no, and 12.6% were undecided.

    Looking at the results, James R. Prudent, Ph.D., president and CEO of Madison, WI-based Centrose, noted that although the FDA regulatory and approval process is complicated, the agency can in some cases cause harm. “It costs $20 million dollars to get an oncology product into Phase I clinical trials,” said Dr. Prudent, whose company is developing novel therapies for cancer. “We are trying to treat people with very serious diseases. The FDA should relax some of its regulations regarding new cancer drugs, particularly those for terminally ill people.”

    Safi Bahcall, Ph.D., president and CEO of Synta Pharmaceuticals, based in Lexington, MA, struck a more conciliatory note.

    “From our experience with the FDA, I believe there are people at the agency who should be national treasures. They ignore the incoming artillery fire of easy sound-bite criticism from every direction and stay focused on the data, making difficult decisions of assessing risk vs. benefit in highly charged situations with often very hard to appreciate subtleties,” he told GEN. “The FDA has recognized that like any large organization there are both structural and organizational improvements they can make to continue to improve. I am hopeful they will continue those changes, including progressive initiatives such as Critical Path, Biomarker Consortium, and the Predictive Safety Testing Consortium that can allow all of us in the public and private sectors together to improve our ability to deliver innovative new medicines that save lives.”

    John Sterling, Editor-in-Chief of GEN, echoed the opinion that the negative poll respondents are mostly reacting to the perception that the FDA is not moving fast enough to approve new therapeutics. “I don’t think the criticism is directed at the FDA per se,” he said. “But I do believe many of our poll respondents are convinced that the agency can do much, much more to get life-saving drugs to patients who are truly in need.”

    “The FDA is underfunded and understaffed”, said GEN publisher, Mary Ann Liebert. “It has a very broad mandate.  This is a long standing issue, and Congress needs to address it to ensure timely evaluations and approvals that will affect health care.”


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