Review Needed in Approval Process

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The new acting head of the Food and Drug Administration, Andrew von Eschenbach, has said that he will take a look at the current drug review process in order to determine whether or not it needs to be amended.

 He is concerned that perhaps the process needs to be changed in order to accelerate the approval of new therapies, which show promise, so as to bring them to market quicker.

 von Eschenbach was quick to note, however, that “speed does not mean recklessness.”

 Currently, von Eschenbach is the acting commissioner for the FDA and the director of the National Cancer Institute; he hopes to be able to carry on in both capacities.

 “Dr. Andrew von Eschenbach’s appointment as acting chief of the Food and Drug Administration is great news for the patient community,” Michael Paranzino, president of Psoriasis Cure Now, said. “Dr. von Eschenbach understands the urgent need to speed to market new treatments for patients.”

 von Eschenbach is also a cancer survivor and an oncologist. He wants to see suffering and death caused by cancer wiped out by 2015. This has caused some stir in the field, as some call it overly optimistic while others simply believe it to be an attention grabber.

 While the current process is the “gold standard,” von Eschenbach is quick to note that “No matter how good it is, the question always has to be asked, ‘can we make it better?'”

 He is committed to ensuring the continued safety and efficacy of the treatments, but feels that promising treatments need to be made available faster, if possible.

 von Eschenbach is looking for stability in the FDA, in addition to closing the gap between science and regulations, including making information available to patients.

 With the FDA facing increasing criticism after incidents such as the side effects related to certain COX-II inhibitors and their subsequent removal from the shelf, they have felt pressure to further ensure the safety of drugs before bringing them to market.

 von Eschenbach does not have plans to completely revamp the process, instead he is focusing on reevaluating the way that drugs are brought through the FDA.

 He has yet to comment on the much discussed “Plan B,” which von Eschenbach’s predecessor delayed deciding on before his recent departure. Plan B is the emergency contraceptive, which manufacturers are attempting to make available without a prescription. A similar product is currently available in Canada without a prescription.

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