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02-06-2007, 03:55 PM | #1 | ||
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In Remembrance
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Kaiser Daily Health Policy Report Highlights Recent FDA-Related
Congressional Committee Actions A number of congressional committees recently have taken action related to oversight of FDA. Summaries appear below. Biotechnology medications: House Energy and Commerce Committee Chair John Dingell (D-Mich.) and committee member Bart Stupak (D-Mich.) last week sent a letter to FDA Commissioner Andrew von Eschenbach to request information about the failure of the agency to approve generic versions of biotechnology medications, CQ HealthBeat reports. According to CQ HealthBeat, "Democrats accuse the FDA of dragging its feet on issuing a policy allowing approvals of generic versions of costly drugs manufactured by the biotech industry." The letter asks von Eschenbach to "state whether you believe your existing authority is sufficient to accept and approve abbreviated applications for biopharmaceutical drugs." The letter adds, "If not, please provide us with a copy of any draft legislation that you believe is required to facilitate the timely approval of these drugs" (Reichard, CQ HealthBeat, 2/2). In addition, the committee has investigated "the adequacy of resources devoted to the agency's Office of Generic Drugs," CongressDaily reports (Johnson, CongressDaily, 2/2). Domestic policy subcommittee: Rep. Dennis Kucinich (D-Ohio) will chair the new House Oversight and Government Reform Domestic Policy Subcommittee, which will focus on prescription drug safety at FDA, CongressDaily reports. Kucinich said that House Oversight and Government Reform Committee Chair Henry Waxman (D-Calif.) has told him to "pursue the agenda that I want." In addition to prescription drug safety at FDA, the subcommittee will focus on the availability of affordable health care in urban areas, among other issues, Kucinich said (Brady, CongressDaily, 2/2). Food safety: The House Energy and Commerce Committee has begun an investigation into FDA efforts to ensure food safety, CongressDaily reports. In a recent letter to Von Eschenbach, Dingell, committee ranking member Joe Barton (R-Texas) and other committee members write that recent E. coli and salmonella outbreaks linked with fresh produce "have raised serious questions about whether the FDA can adequately protect the nation's food supply." According to the letter, the budget for the FDA Center for Food Safety and Applied Nutrition decreased by almost 50% in the last three years (CongressDaily, 2/2). Prescription drug safety: Senate Health, Education, Labor and Pensions Committee Chair Edward Kennedy (D-Mass.) and ranking member Michael Enzi (R-Wyo.) have reintroduced a bill that would provide FDA with more authority to regulate prescription drugs after they have reached the market, CQ HealthBeat reports. Kennedy said that the bill, first introduced in the 109th Congress, would provide "a more effective system to identify and assess the serious risks of drugs, inform health care providers and patients about such risks and manage or mitigate these risks as soon as they are detected." In addition, the legislation would establish a public database of clinical trials and also would screen FDA advisory committee members for financial conflicts of interest, Kennedy said (Carey, CQ HealthBeat, 2/2). Editorial Lawmakers should "listen to what doctors have to say" about the current FDA approval process "before they make valuable treatments even harder to obtain," a Wall Street Journal editorial states. According to the editorial, the September 2004 withdrawal of the COX- 2 inhibitor Vioxx prompted congressional "demands for tougher FDA regulation and an explosion of litigation against the pharmaceutical industry," but 80% of orthopedic surgeons surveyed in a recent poll released by the Competitive Enterprise Institute said that the medication should return to the market. Orthopedic surgeons "work regularly with people suffering from chronic pain," and, because they "know that almost all drugs have risks," they "see no sound reason Vioxx should be ruled out as an option for patients who can't find relief elsewhere," the editorial states. In addition, according to the poll, 76% of respondents said that FDA approval process is "too slow"; 60% said that "on balance" FDA regulations "hinder" rather than help their ability to treat patients; and 70% said that they support expanded access to experimental medications, the editorial states. The editorial concludes, "This year promises to be an important one for the FDA, with the complicated Prescription Drug User Fee Act up for reauthorization and a number of senators urging even stricter regulation under the guise of 'reform,' and lawmakers should consider the opinions of physicians before they take action (Wall Street Journal, 1/3).
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paula "Time is not neutral for those who have pd or for those who will get it." |
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02-06-2007, 04:47 PM | #2 | |||
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Member aka Dianna Wood
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Hi Paula,
Why do the doctors have to spend so many years and pay for costly education if they are not going to allowed to help their patients as they see fit? I went to an orthopedic surgeon on Feb. 2nd. He wants to request an MRI test to see what is causing me so much pain in my left shoulder. The wire from my DBS is covering the part of the shoulder he wants to see. He would also like to see if their is tears in muscle tissue as bone spurs showed up in the x-ray. The MRI is located in his offices and up until Feb. 1, 2007, he would have been able to have it done on the same day. Now, however, a new procedure has been put in place by my HMO that requires he send his request to a different group to get approval for the test. If it is disapproved, I will have to go through the process of arguing my need for the test adding more stress to a disease that thrives on it. Vicky |
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02-06-2007, 05:15 PM | #3 | ||
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In Remembrance
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yes, Vicky.....seems like doctors' hands are tied from several directions. Everyone needs an attitude adjustment and the businesses need a few ethics courses. Industry and insurance companies put such a squeeze on the doctors.
But I do think their situations will improve only as much as they acknowledge that there are patients who are willing to help solve the illnesss. Hard working medical people who "get it" need us too. The number is increasing pretty quickly now. Sen. Kennedy is familiar with the GDNF case and actually tried to get a similar bill to the Enzi Kennedy bill through Congress before, but his timing wasn't right. He filed 9/10/01. That story was told to us while interviewing GDNF trial participants attorney, Mr. Milstein. Wanted you to know it was a reliable source. Vicky, large institutions are impossible. We learned that in college, which was created to frustrate you in preparation for things like this. Never mind about logic. paula
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paula "Time is not neutral for those who have pd or for those who will get it." |
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02-06-2007, 05:40 PM | #4 | ||
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Member
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Hi Vicki,
I'm probably about to say something you already know but here goes (just in case.) You need to get someone, Medtronic rep, programmer or neurologist to switch off your neurostimulators with their machine just before the MRI, it's vital. The ARC we're given doesn't zero the settings the same way. Cheers, Lee |
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