Article FDA footdragging FYIFDA's footdragging hurts Canada's biotech firms
By Scott Anderson
TORONTO (Reuters) - Canadian biotechnology companies havejoined a chorus of their global counterparts to rail againstthe U.S. Food and Drug Administration's tardiness in approvingnew drugs.
Products by companies such as Labopharm Inc andCardiome Pharma Corp have been delayed in the key U.S.market for months, chipping into their revenue and waylayingtheir plans.
The FDA has blamed a severely depleted staff and dwindlingfunds for the holdups in approving treatments, while it alsodeals with an overly cautious U.S. Congress that is keen toturn over every stone.
However, some critics say part of the problem stems fromadded scrutiny in the wake of the handling of the arthritispill Vioxx, which was withdrawn by Merck & Co in 2004following a link to heart attacks.
"It's going from the sublime to the ridiculous thatprograms that have cost hundreds of millions of dollars andmany years to develop are being hung up by a couple of whinybureaucrats," said Brian Bapty, a biotechnology analyst atRaymond James Ltd, in Vancouver, British Columbia.
"The FDA is quibbling about staffing levels and funding,yet companies who are trying to get some of these drugsapproved of which could sell for billions of dollars a year arebeing held for many months because of issues at the FDA."
This has been a source of frustration for the companies.
"Any time that things aren't going as quickly as possible,there is a certain level of frustration, but the reality isthat we are in a regulated environment," said CardiomePresident Doug Janzen.
Cardiome is waiting to collect a $15 million milestonepayment from its development partner Astellas Pharma <4503.T>when the FDA approves its Vernakalant heart drug.
In December, an arm of the FDA voted in favor ofrecommending that the intravenous drug be approved, but adecision for the application, first submitted in December 2006,was not given before the January 19 deadline.
"This is something of a different FDA today than it wasthree or four years ago," said James Howard-Tripp, presidentand chief executive at Labopharm.
"What used to be very good about the FDA is that you usedto get considerable clarity and very decisive decision making."
Labopharm, which has struggled to get its once-dailyversion of the pain killer tramadol to market for severalyears, has also faced a series of delays as it tries to satisfykey data requirement requests from the FDA.
The drug agency's drawn-out approval process has beencostly for Labopharm and its development partner, Purdue PharmaLLP, Howard-Tripp said. The company expected approval inSeptember 2006, and had prepared for its launch in both 2006and mid-2007.
Howard-Tripp said the delays were the result of the FDA'sdecision to alter data requirements midstream, and that thestatistical method the FDA proposed for a new analysis of thedata was different from what it previously requested.
To be sure, cooperation could facilitate the approvalprocess, said Christopher Gallen, president and chief executiveofficer at Neuromed, a privately held maker of pain medicine.
By working with the FDA ahead of time and setting out theguidelines, Gallen said there were no regulatory surprises and"it's very possible to move good, safe, effective drugs forwardin a reasonably expeditious way."
But patience isn't a virtue for some.
Bellus Health , formerly known as Neurochem,skirted the FDA process by renaming its Alzhemed Alzheimer'sDisease treatment "Vivimind" and classifying it as a"nutraceutical."
This new branding allowed the company to avoid jumpingthrough the same hoops required by the FDA in approving a drug.
Raymond James' Bapty warned it was a matter of time beforethe multibillion-dollar biotechs reach boiling point and bandtogether to flex their political muscle.
"It could come to a very big head. You will see tremendousinfluence brought to bear on the governing bodies and thepoliticians overseeing how the FDA gets funded," Bapty said.
($1=$0.98 Canadian)
(Reporting by Scott Anderson; Editing by Bernadette Baum)