October 7, 2013 – Oregonlive.com
By Mike Francis
SAM Medical Products of Wilsonville hoped to roll out a new chitosan dressing intended to stop severe bleeding, but the shutdown of the federal government has delayed the rollout indefinitely.
The privately held company sent the Food and Drug Administration its extensive application to sell the product on Sept. 27, launching a process that normally takes about 90 days, said Adrian Polliack, the firm’s president. Instead, the company got a letter saying that the agency’s medical device approval business has been shut down because of the clash between Republicans and Democrats on Capitol Hill. Only the most essential FDA services — such as food-borne health issues — are continuing during the shutdown.
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For SAM Medical Products, which employs roughly 40 people, that means the domestic launch of the potentially life-saving product called Chito-SAM 100 will be pushed beyond the hoped-for date of mid-December. If the shutdown continues for weeks, the company will be forced to revise its revenue forecast, Polliack said.
The company had arranged distributorships and was preparing to push the product to military and commercial customers in the business of emergency medicine, Polliack said. But now the entire project is on hold.
“I think we all really expected that this could happen,” Polliack said of the government shutdown. “But we never realized the impact on our business.”
SAM Medical has received clearance to sell the product in Europe, but the larger domestic market remains closed until the FDA goes back to work, he said.
For SAM Medical, the government shutdown has become “very real,” he said.