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Bilbray Hears Complaints from Local Biotechs

International Stem Cell Corporation, a local biotech, announced that it recently met with Representative Brian Bilbray to discuss concerns over federal policies relating to stem cell research. Bilbray, who represents California’s 50th district covering large portions of northern San Diego County, is a member of the House Energy and Commerce Committee and its Subcommittee on Health. In addition to his meeting with the private firm, he and Rep. Michael Burgess, a Texas Republican and vice chair of the subcommittee, last week held a local hearing where they discussed similar issues with other biotechnology executives.

A common complaint among medical researchers is that the Food and Drug Administration puts too much emphasis on preventing harm to patients, taking too long to approve new medicines and making them costly to bring to market. Medical industry representatives also say the FDA, in its quest to avoid conflicts of interest where people with an interest in a drug’s approval have a hand in granting it, will often use reviewers who aren’t sufficiently familiar with the topics they’re evaluating.

If government restrictions aren’t eased, some say, companies may begin fleeing the US for markets with less-stringent testing and approval processes. “We're in dire straits. In five years, you're not going to have to worry about regulating innovative drugs, because there's not going to be any,” says Steven Mento, president and CEO of Conatus Pharmaceuticals Inc.

Bilbray issued a statement in support of the business community after the meetings, saying: “It is no secret that the best markets are the freest markets. Removing government barriers to job growth is necessary in any business, whether it be in a biotech company looking for the cure for cancer or a device company making an artificial pancreas for a diabetic. Unfortunately, we have seen the FDA put up roadblock after roadblock for companies looking to expand their businesses and develop the next great breakthrough.”

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International Stem Cell Corporation, a local biotech, announced that it recently met with Representative Brian Bilbray to discuss concerns over federal policies relating to stem cell research. Bilbray, who represents California’s 50th district covering large portions of northern San Diego County, is a member of the House Energy and Commerce Committee and its Subcommittee on Health. In addition to his meeting with the private firm, he and Rep. Michael Burgess, a Texas Republican and vice chair of the subcommittee, last week held a local hearing where they discussed similar issues with other biotechnology executives.

A common complaint among medical researchers is that the Food and Drug Administration puts too much emphasis on preventing harm to patients, taking too long to approve new medicines and making them costly to bring to market. Medical industry representatives also say the FDA, in its quest to avoid conflicts of interest where people with an interest in a drug’s approval have a hand in granting it, will often use reviewers who aren’t sufficiently familiar with the topics they’re evaluating.

If government restrictions aren’t eased, some say, companies may begin fleeing the US for markets with less-stringent testing and approval processes. “We're in dire straits. In five years, you're not going to have to worry about regulating innovative drugs, because there's not going to be any,” says Steven Mento, president and CEO of Conatus Pharmaceuticals Inc.

Bilbray issued a statement in support of the business community after the meetings, saying: “It is no secret that the best markets are the freest markets. Removing government barriers to job growth is necessary in any business, whether it be in a biotech company looking for the cure for cancer or a device company making an artificial pancreas for a diabetic. Unfortunately, we have seen the FDA put up roadblock after roadblock for companies looking to expand their businesses and develop the next great breakthrough.”

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