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Biotech firms want drug approval hastened

Say innovation is impeded by process

James C. Greenwood is BIO’s president. James C. Greenwood is BIO’s president.
By Robert Weisman
Globe Staff / June 22, 2011

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Biotechnology industry leaders want to speed up the process of bringing drugs to market by broadening the mission of the Food and Drug Administration, the federal agency that reviews new medicines, to include innovation as well as product safety.

A raft of industry proposals to overhaul the FDA and create fresh incentives to help fund drug development will be unveiled in Washington next week at the 2011 international convention of the Biotechnology Industry Organization, known as BIO.

“We want to change the formal legal mission statement of the FDA,’’ BIO president James C. Greenwood said in Boston yesterday. “The FDA understands that if they approve a product that’s not safe or effective, that’s a failure, and we agree with that. But it’s not deemed a failure if people die because they took too long to approve a product.’’

Greenwood was attending the CEO Biotech Conference at the Mandarin Oriental Hotel, where earlier in the day Senator Scott Brown accused the FDA of “crushing innovation’’ and “throwing a wet blanket’’ on drug discovery and medical device development by delaying decisions on new therapies, changing the rules along the way, and being unresponsive to businesses seeking to sell lifesaving technology.

“There’s a complete breakdown between what’s happening at the FDA and what your needs are,’’ the Massachusetts Republican told the biotechnology executives. “It’s money, it’s time, it’s innovation, and right now we’re losing out to competition overseas.’’

Brown said the agency’s slow pace also limits job creation by Massachusetts companies.

FDA officials said yesterday that the agency already focuses on innovation. They pointed to an April speech by Commissioner Margaret A. Hamburg in which she said, “Our job is both to ensure the safety and efficacy of FDA-regulated products and to take real steps to foster the scientific innovation that will lead to tomorrow’s new breakthrough products.’’

Addressing Brown’s criticism, FDA spokeswoman Karen Riley said part of the reason it takes so long to get drugs on the market is the length of companies’ clinical trials. She said the agency approves 60 to 80 percent of submitted drug applications, but most experimental treatments never get that far — 70 percent of drug candidates fail in mid-stage trials and 55 percent fail in late-stage trials, Riley said.

“This failure in clinical drug development is the root of the pipeline problem,’’ she said. “FDA has established standards so that the outcome of the review process is predictable. But scientific uncertainty, especially for highly innovative products and indications, remains high.’’

Sheila Weiss Smith, director of the Center for Drug Safety at the University of Maryland’s School of Pharmacy, agreed the FDA’s pendulum has swung toward safety in recent years.

In a 2006 article, Weiss Smith chastised the agency for not taking safety seriously. She warned that the industry’s push to accelerate drug approval could come at the expense of safety.

Too often in the past decade, “it was all about innovation and speeding it up and getting drugs to market,’’ Weiss Smith recalled. “There were cases where the [FDA’s] decisions weren’t wise, and they put drugs on the market that had to be withdrawn.’’

Greenwood said BIO hired a life sciences consulting firm, Zerhouni Group, to survey industry leaders on what policy changes would spur innovation.

The proposals, which will be detailed next week, include regulatory changes such as expanding the FDA’s mission, making it independent from its parent, the Department of Health and Human Services, and creating a fixed term for the FDA commissioner to make the agency less risk-averse.

Other proposals would help companies raise drug-research money by providing tax breaks to individual “angel’’ investors, and offer federal matching funds for venture capital investments.

Brown, after his speech, said he discussed the industry’s frustrations in a meeting with the FDA’s Hamburg two months ago.

He also said he intervened with the Patent and Trademark Office to help Dr. Robert Sackstein, a Harvard Medical School professor and bone marrow transplant physician at Brigham and Women’s Hospital in Boston, win a patent for a technology that had already been approved in Europe and Asia.

“There’s so much overregulation right now in Washington,’’ Brown said.

Sackstein confirmed that Brown helped to break the bureaucratic logjam.

He said the US patent was key to commercializing his technology, a device that can modify the surface of stem cells to guide them through the bloodstream to treat injuries.

Others at yesterday’s meeting also pointed to regulatory uncertainty as a roadblock to attracting money for development work.

“These investors are already taking on scientific risk, management team risk, and business model risk,’’ said David L. Lucchino, chief executive of Semprus Biosciences, a Cambridge medical device company. “If you don’t know what the FDA’s rules are going to be, it’s very disconcerting to the investors.’’

The drug approval process is especially daunting to the dozens of small and mid-size life-sciences firms that make up a large part of the industry in the Boston area, said Robert K. Coughlin, president of the Massachusetts Biotechnology Council.

“If it takes a total of 12 years and over a billion dollars to get a drug from the [lab] bench to the bedside, it takes too long and it’s too costly,’’ he said.

Robert Weisman can be reached at weisman@globe.com.