Harry James

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

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.

They also point to a recent string of unexpected new drug rejections by the agency that forced developers to perform new tests on their experimental medications.

Just in the past six months, the FDA turned down three drugs from San Diego companies: diet pills from Arena Pharmaceuticals and Orexigen Therapeutics, and a weekly injectable diabetes therapy from Amylin.

In a recent survey by Biocom, industry executives said the agency's review process lacks transparency, often becomes sidetracked by unexpected issues and takes too much time.

"We see a growing concern that the FDA is becoming detached from the industry," said Joe Panetta, president and chief executive of Biocom.

Many of the problems can be blamed on a cultural change at the agency that raised the emphasis on potential risks that new drugs and devices pose in the wake of a long string of high-profile medical product recalls, Gollaher said.

Still, some people say the changes have been good. Public Citizen and other consumer advocacy groups have praised the FDA for scrutinizing new medical products more intensely and requiring more safety testing before allowing them onto the market.

One possible way of shifting the agency's focus more toward the potential benefits of new products is to give a formal role in the regulatory review process to the patients who would use the drugs and devices, said Duane Roth, chief executive of Connect San Diego, a nonprofit support group for fledgling technology companies.

"It's their disease," he said. "It's not yours, and it's not ours. Until they get in there to help us, I don't think much will change."

UCSD Chancellor Marye Anne Fox implored the lawmakers to resist urges to cut basic science grant funding from the National Institutes of Health, which sent $824 million to her university and other scientific institutes in the county last year.

The money produces many of the discoveries that are later taken up by biotechnology companies and turned into products.

keith.darce@uniontrib.com (619) 293-1020

James Harris Associates is devoted to providing operational, technological, and regulatory services to the Pharmaceutical and Biotechnology industries. Our confidential services are provided in manufacturing, quality, engineering, materials management and logistics, regulatory, and training. We routinely serve clients in the United States, Europe and Asia. Skilled consultants assist in facility or process upgradesm validation, start-up, new facility design, location services, FDA liaison, and product registration.

 

About the Author

James Harris Associates is devoted to providing operational, technological, and regulatory services to the Pharmaceutical and Biotechnology industries.
Our confidential services are provided in manufacturing, quality, engineering, materials management and logistics, regulatory, and training. We routinely serve clients in the United States, Europe and Asia. Skilled consultants assist in facility or process upgradesm validation, start-up, new facility design, location services, FDA liaison, and product registration.

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