The drug approval lag, which was last seen during the 1980s and 1990s before user fees were authorized, was thoroughly discussed during an Institute of Medicine drug safety meeting in Washington, DC in September. FDA Office of New Drugs' John Jenkins told the meeting that observers of the new drug approval typically complain that FDA has become too conservative, and that the process has become so complex it is making it almost impossible to achieve approval even for a drug that the agency thinks is ready to be approved on the first cycle.
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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