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					Is safety causing a drug approval lag?                                                                          Pipeline
                                                                                                                Amgen received
Could reCently added                                                     the analysis is premature at this      a Complete Response
                                                                                                                Letter from the FDA on
drug safety mandates from                                                point but it is something that we
                                                                                                                Prolia (denosumab), a
the FdA Amendments Act                                                   are watching closely.”
                                                                                                                potential blockbuster
and ongoing public criticisms                                               Jenkins told the meeting
                                                                                                                indicated for the treat-
about drug safety lead to a drug                                         that observers of the new drug
                                                                                                                ment and prevention
approval lag in this country?                                            approval typically complain that
                                                                                                                of postmenopausal
   Such a lag, which was last                                            FdA has become too conser-
                                                                                                                osteoporosis. The letter
seen during the 1980s and 1990s                                          vative, and that the process has
                                                                                                                asked Amgen to provide
before user fees were authorized,                                        become so complex it is making         further information on
was thoroughly discussed during                                          it almost impossible to achieve        a previously submitted
an Institute of Medicine (IoM)                                           approval even for a drug that          post-marketing program,
drug safety meeting in Washing-                                          the agency thinks is ready to be       but did not request any
ton, dC in September. Meeting        Jenkins: drug approval process      approved on the first cycle.           additional trials. FDA
chair and Merck executive vice       is becoming incredibly complex         Jenkins said: “It’s hard to         also asked for updated
president for regulatory affairs                                         quantify if my division directors      safety data related to the
Peter Honig prefaced the discus-     to develop reMS.                    or office directors are affected       drug, known informally
sion by pointing out that first-        “even products that have         by the drug safety debate that         as Dmab.
cycle approval trends are down       very positive advisory commit-      has been raging in this country
and that user-fee target dates are   tee votes are not approved or are   for the past five or six years…        FDA approved
routinely missed (13 products        given longer delays,” he said. “I   Are they less likely to approve        Boehringer Ingelheim’s
missed deadlines last year).         think the numbers are small, but    a drug today with the same data        Micardis 80mg tablets
   He quoted FdA office of           of the 46 compounds analyzed in     package that they might have           for cardiovascu-
new drugs’ John Jenkins as           2006 to 2008 there were several     done five years ago? It is almost      lar risk reduction
having publicly stated that the      approved by the eMeA only,”         impossible to answer that ques-        in patients 55
last month of the approval cycle     Honig said, “and obviously there    tion because you can’t make            and older, and
has become more difficult due to     were some approved by FdA           those assessments.”                    also approved
drug safety issues like the need     and not approved in europe. So                —James G. Dickinson          Twynsta (telmis-
                                                                                             
				
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