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-