From the Globe this morning:
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Drug approvals seen slowing
Safety, leadership issues plague FDA, industry charges
By LEONARD ZEHR
BIOTECHNOLOGY REPORTER
Monday, December 10, 2001 – Page B3
Heightened safety concerns and a lack of leadership at the top of the U.S. Food and Drug Administration are combining to slow new drug approvals, industry executives and analysts charge.
Leading pharmaceutical and biotech companies such as Pfizer Inc., Roche Holding SA, Pharmacia Corp., American Home Products Corp., Novartis AG, Eli Lilly and Co., Amgen Inc. and Genentech Inc. have suffered regulatory setbacks this year, often blaming the "current environment" at the FDA.
Observers point to a shopping list of reasons for the FDA raising the bar on drug approvals, which can slash hundreds of millions of dollars in drug sales and delay new therapies from reaching patients.
High on the list is the firing of FDA commissioner Jane Henney by the Bush administration last January and the lack of a replacement.
"The FDA is headless and bureaucratic caution has set in," said Carl Feldbaum, president of the Biotechnology Industry Organization, a Washington, D.C., trade group that represents more than 1,000 biotechnology companies and institutions in the United States.
One of the latest casualties is Toronto-based Hemosol Inc. After vetting final clinical trials for its Hemolink blood-substitute product with the agency, the company was told last summer to stop the trials, a move that caused its stock price to collapse.
"It caught us by surprise because we thought we had worked through all their issues," said Hemosol president and chief executive officer John Kennedy.
Hemosol's revised protocols were recently accepted by the FDA and the pivotal Phase III trial is about to begin. But the upheaval has delayed a regulatory filing by 12 months until mid-2003.
"What I think is happening at the FDA is that the products are not getting any simpler and require great understanding of molecular biology and immunology," Mr. Kennedy said.
"I think the science and technology often are very far ahead of the reviewers' background so the people setting policy have to go to school on the technology and that can take time."
In the past five years, the FDA has pulled 14 drugs off the market for safety concerns. Observers attribute the recent slowdown in drug approvals to a stronger stance on safety, the agency's No. 1 priority.
"An environment has been created where everyone at the FDA is afraid to make a mistake and no one wants to assume any risk in approving new therapies," said Eric Schmidt, an analyst with SG Cowen Securities Corp.
Added Mr. Feldbaum: "Clearly, the process at the FDA has slowed down."
Longer approval times could have an impact on Canadian companies preparing to file applications next year to sell drugs or products.
The list could include Angiotech Pharmaceuticals Inc., AnorMed Inc., Axcan Pharma Inc., Biovail Corp., Cangene Corp. and AltaRex Corp., which has moved to Massachusetts but still trades on the Toronto Stock Exchange.
Earlier this year, SG Cowen assembled a group of Washington insiders for a conference call to discuss the regulatory environment at the FDA. Besides agreeing that a new FDA commissioner would solve some of the agency's ills, the consultants also suggested that:
The FDA's more conservative stance toward safety represents a "broad shift in attitude stemming from congressional pressures and a zero-tolerance policy" for the withdrawal of new drugs from the market.
The approval productivity of the agency as a whole has slowed down.
The appointment of a new FDA commissioner has become highly politicized and is likely to result in the appointment of an "ideal Republican" rather than an "ideal commissioner."
According to the FDA, new drug approval times have fallen from a median of 22 months in 1992 to less than 12 months in 1999, although there was a slight increase in 2000 and 2001.
Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said the agency is receiving fewer drug applications so fewer products are being approved.
"We're also seeing more . . . less-than-ideal filings that don't have all the necessary analyses and have to be sent back," she added.
On the other hand, she said the FDA has broadened its scientific understanding of drug safety and the risks, for example, of altering electrical signals in the heart. "We approved some drugs in the 1980s because we didn't know any better."
Even though the agency recently approved two Amgen drugs, Kineret for rheumatoid arthritis and Aranesp for kidney failure, Mr. Schmidt said those drugs were filed well over a year and a half ago, which "doesn't exactly increase our confidence that FDA approvals are coming in a timely fashion."
Andre Uddin, an analyst with Research Capital Corp., attributes the slowdown to some 12,000 new molecular entities in clinical trials.
"With so many products running through the clinic, there is no question that the FDA's capacity for reviewing investigational new drug applications is being considerably exhausted," he wrote in a recent research report.
Mr. Uddin warns investors to bet on longer FDA approval times for pharmaceuticals and biological products. "The standard 12 months should no longer be applied," he said. |
