Letters To The Editor, Opinion Piece Discuss Issues Related To FDA, Prescription Drug Regulation
Henry Miller, Wall Street Journal: A Feb. 6 Journal editorial is "correct that 'spend(ing) more money' alone will not remedy FDA's most significant problems," which are "mismanagement, a corporate culture that is excessively risk-averse and lack of accountability," Miller of the Hoover Institution writes in a Journal letter to the editor. "Repeatedly accused, unfairly, of not being sufficiently concerned about drug safety," FDA continues "raising the bar for approval, especially for innovative high-tech products," Miller writes. According to Miller, a regulator that is "not sufficiently comfortable with a new technology is a fearful regulator; and a fearful regulator doggedly applies old paradigms to novel situations, slows down every phase of clinical development and requires unnecessary testing" to provide "cover should anything go wrong." He adds, "Effective management must employ sticks and carrots judiciously," but regulators are "consistently rewarded for over-regulating and for delaying" the development of new medications. Miller recommends the establishment of a "powerful independent agency ombudsman" that could administer "punishment for deficient performance" to "induce regulators to act in the public interest." He concludes, "This new entity could begin to alter FDA's culture of risk aversion and mistreatment of innovation" (Miller, Wall Street Journal, 2/15).
Jonathan Seltzer, Wall Street Journal: A report released by the FDA Science Board is "correct in pointing out that FDA's 'evaluation methods ... largely unchanged over the last half-century' cannot keep pace with scientific advances," but "even more distressing" is that these "antiquated evaluation methods haven't kept pace with the evolving expectations of the public and the medical community," Seltzer, director of clinical research at the Main Line Health Heart Center, writes in a Journal letter to the editor. He adds, "I sympathize with the regulator's need to use fixed and objective standards to adjudicate 'safe and effective,'" but such "rigidity" can lead to "nonsensical decisions" in which experimental medications are rejected "because of statistical, not clinical, criteria." Seltzer concludes, "Although historically, 'new statistical methods' usually begin with an academic search for increased complexity, why not use" the recommendation by the board to "develop an appropriate, common-sense statistical methodology that will support a more transparent and rapid approach" to development of new medications (Seltzer, Wall Street Journal, 2/15). Opinion Piece
The Government Accountability Office has found that 80% of the ingredients used by U.S. pharmaceutical companies are imported, and, as a result, "most of our medicines and medical products are manufactured in thousands of unregulated, unsupervised plants run by managers who have no ... obligation to use safe ingredients in preference to those that are cheaper," syndicated columnist Phyllis Schlafly writes in a Washington Times opinion piece.
However, the "problem is not merely the crime but the cover up of violations" by foreign manufacturers of medications, according to Schlafly. She writes that FDA is "so overwhelmed by the flood of cheap drug imports that it is simply incapable of protecting the public from unsafe drugs and medical devices, as well as food," adding that the agency likely could not "protect us from contaminated Chinese drugs even if it had tenfold its current budget" (Schlafly, Washington Times, 2/15).
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Scrisori de editor, avizul bucata discuta probleme legate de FDA, Regulamentul de prescripþie de droguri - Letters To The Editor, Opinion Piece Discuss Issues Related To FDA, Prescription Drug Regulation - articole medicale engleza - startsanatate