Harris James Associates Update: Congressional forum on biotech jobs focuses on FDA

Harris James Associates Update: Overly cautious government regulators, threats to basic science research funding and burdensome taxes are holding back job creation by drug and medical device companies and slowing the delivery of innovative new therapies to patients, biotechnology industry experts told federal lawmakers Thursday during a hearing in San Diego.
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Most of the criticism was directed at the Food and Drug Administration, which approved 21 new drugs last year, compared to 36 in 2004.
“There are whole areas (of drug development) that venture capitalists won’t pursue because the regulatory barriers are too high,” said David Gollaher, president and chief executive of the California Healthcare Institute in La Jolla.
The complaints were familiar to anyone who has followed drug and medical device development in the United States over the past several years.
Gollaher and the other experts delivered their comments to Rep. Darrell Issa, R-Vista, during a morning public forum at the University of California San Diego. Since he became chairman of the House Oversight and Government Reform Committee in early January, Issa has hosted 10 such gatherings around the country focused on regulations that stifle economic expansion.
For the latest gathering, he returned to his home county, where more than 400 companies make up a major biotechnology hub that employs more than 40,000 people, according to the San Diego trade group Biocom.
Issa was joined by Reps. Susan Davis, D-San Diego; Brian Bilbray, R-Solana Beach; and Duncan Hunter, R-Alpine.
Issa’s committee has broad investigative power, but any legislation addressing specific regulatory changes would be handled by other congressional panels that directly oversee the related agencies.
“We’re here today because San Diego is a miraculous story of biotech,” Issa said in comments that opened the 1½-hour session.
To aid his investigation, Issa solicited comments from hundreds of individuals, companies and trade groups, including many in the biotechnology and pharmaceutical industries, both directly and through a special website, americanjobcreators.com.
“We were shocked to find out that the FDA is often one of the greatest impediments to job creation,” the congressman said.
Critics of the agency say the problem is most clearly displayed in the increasing amount of time that it takes the agency to process new product applications.
Since 2007, drug review times by the FDA have increased by 28 percent, while evaluations of devices have taken as much as 75 percent more time, Gollaher said.

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