In a rare display of bipartisanship, both Republican and Democratic Senators agreed the Food and Drug Administration is under funded for next year. “To us, it’s clear that they’re seriously under funded,” said Senator Herb Kohl at the Appropriations subcommittee hearing on Tuesday. Kolh, a democrat from Wisconsin, is the head of the Appropriations subcommittee which oversees the FDA’s spending.
Senator Robert F. Bennett, Republican of Utah, the subcommittee’s ranking minority member agreed with Kohl and pressed Dr. Andrew C. von Eschenbach, the food and drug commissioner, to say how much more money the FDA needed. Dr. von Eschenbach replied he would “welcome an opportunity to present a scenario of portfolio options” for financing. He also expressed doubt that the FDA could accommodate the 20 percent budget resolution passed by the Senate last month. That’s an additional $375 million over the 2008 allocated budget which comes from taxpayer revenue as opposed to money that comes from user fees paid by drug and medical device companies.
• A report by a panel of outside advisors released last year, asserts American lives were in danger because the FDA didn’t have the money, staff or the scientific expertise to protect them.
• Last month, Dr. von Eschenbach says the FDA “may fail in its mission to protect and promote the health of every American” and that “peril exists.”
• At the hearing on Tuesday, Dr. von Eschenbach reverses his stance and claims, “I believe we have been eminently successful up to this period of time.” He continues, “We are the world’s gold standard.”
• Dr. von Eschenbach testified at the hearing, in response to the heparin controversy, the contamination of heparin whose active ingredient which had been imported from China was “apparently, we suspect, done by virtue of economic fraud,” to enhance profit.
• After the hearing, Dr. von Eschenbach does an about face and says “he probably went too far” in his testimony. He claims the FDA does not have proof that the contamination was deliberate and fraudulent.
So, between a commissioner who flip-flops his position on an almost daily basis and an agency that is seemly run by the drug companies as the FDA approves drugs at the whim of drug companies as shown by the heparin debacle, the Vioxx tragedy, and Vytorin and Zetia half truths, we as consumers need to accept the fact the FDA as it exists today is not functioning in our best interests.