A Senate committee is considering re-authorizing some bills that affect the industry.
Maryland Senator Barbara Mikulski was in Frederick on Tuesday on a listening tour. The state's senior senator met with local biotech company representatives to talk about regulation.
Currently, the Senate Health Education, Labor and Pension Committee is considering the re-authorization of the Prescription Drug User Fee Act and the Medical Device User Fee Act. Both assesses fees on drug, device and biotechnology companies to support drug and device applications.
Senator Mikulski says the company representatives want to keep Food and Drug Administration regulations. "Because FDA is the gold standard for approving drugs and medical devices that can be sold in the United States of America, and then be sold around the world," she says.
But Mikulski said the industry officials want the FDA to be their ally. "Available for enabling them to be on the right track as they move their ideas from research into clinical trials, and to work with them along the way to make sure they can stay on the right track," she says. "So, quite frankly, we can get it on the fast track out in the clinical marketplace."
Senator Mikulski says she heard a lot of good ideas from industry representatives. "So I am taking these ideas back. I've got excellent ones on how to improve communication, and facilitate and fast track drug approval."
Mikulski met with senior representatives from Medimmune, Human Genome; DyPort Vaccine Co.: ImQuest Biosciences; Life Technologies; Lonza; Royer Biomedical, Inc.; SAIC-Frederick, NCI; and the Maryland Biotechnology Center.
