Dr. David Orloff quit the FDA to join a CRO (see NYT piece below) - perhaps further reinforcement of traumatic times at the agency. We suspect this is not a positive for anything being filed about right now - can't be helpful for DPP-IVs, can't be helpful for Acomplia, can't be helpful for inhaled insulin. Recall that Dr. Orloff spoke very positively about inhaled at the panel meetings, and it seemed during his intro that approval was a foregone conclusion. We suspect it still is, essentially, but that post-survillance will be high. The DPP-IVs? We are not as sure, given the non-inferiority trial with Metformin earlier this year. Yet and still, we think the agency wants credit for creating alternatives ... that's a positive driver for all the drugs. In this environment, we think a key question is how fast uptake will be - depends of course of pricing, reimbursement, and coverage, but even beyond that, we don't think PCPs are beating doors down to be the first to try drugs these days ... not in this safety environment, no matter how safe the drugs actually are they have at hand. Dr Orloff's departure, on the other hand, does seem a net positive for Amylin, who will just continue to benefit from slow/no movement around them in terms of the competitive landscape.
We bet it will take forever to replace Dr. Orloff. Deputy Director Mary Parks replaces Orloff - we suspect an internal promotion will take place, possibly of Dr. Parks. She has a big job ahead of her.
December 7, 2005
F.D.A. Official Becomes 3rd to Quit Agency Since Summer
By STEPHANIE SAUL
A Food and Drug Administration official whose office was involved in a recent controversial application for drug approval said yesterday that he was resigning to join private industry.
Dr. David Orloff, a division director who oversees the review of drugs to treat metabolic and endocrine disorders, is set to join Medpace, a contract research organization based in Cincinnati that runs clinical drug trials.
Dr. Orloff was in charge of the F.D.A.'s review of Pargluva, a diabetes drug from Bristol-Myers Squibb that was recommended for approval by an F.D.A. advisory panel in September. The drug has since been postponed indefinitely as a result of cardiovascular safety concerns.
Dr. Orloff said his decision to leave after 11 years at the F.D.A., with 5 of them as a division director, was not related to any problems or frustrations but reflected a new opportunity.
"I wasn't looking to leave, and I've been very happy here," he said.
Dr. Orloff's departure from the F.D.A. will be the third by a ranking agency official since the summer. In September, the F.D.A.'s top administrator, Dr. Lester M. Crawford, resigned for reasons still to be fully explained, only weeks after he was confirmed as the agency's commissioner. In August, Dr. Susan F. Wood, the top women's health official, resigned in protest over delays in approving the Plan B contraceptive for over-the-counter sale.
In a telephone interview yesterday, Dr. Orloff defended his office's handling of the Bristol-Myers application for Pargluva, which would have been the first in a new class of drugs intended to control diabetes and fat levels in the blood.
In October, the F.D.A. said the drug could be approved but only with additional clinical trial data. At the time, Bristol-Myers said the F.D.A.'s questions could be answered with the results of continuing clinical trials.
But two days later, The Journal of the American Medical Association published a blistering critique of the drug's cardiovascular safety by Dr. Steven E. Nissen and colleagues from the Cleveland Clinic. After additional consultations with the F.D.A., Bristol-Myers announced that it would be several years before the drug could be cleared, indicating that a longer study was necessary.
"We learned nothing new from the Nissen article," Dr. Orloff said. "We were aware of all those issues."
Dr. Orloff said he would remain with the agency for about a month.