Biotech lobbyists chafe as regulation grows - Sent Using Google Toolbar

Biotech lobbyists chafe as regulation grows

Biotech lobbyists chafe as regulation grows

By Stephen Pounds

Palm Beach Post Staff Writer

Wednesday, October 17, 2007

WESTON — Biotechnology as an industry is growing, but with its higher profile has come greater scrutiny from government - which also is one of its biggest customers.

Industry lobbyists meeting today on the second and final day of the 10th annual BioFlorida conference outlined the increased regulatory activity biotech companies are running into from federal and state governments.

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Christopher Badgley, vice president of the Pharmaceutical Research and Manufacturers of America, said 46 states, including Florida, enacted "anti-industry" legislation last year.

The industry faces drug-price controls, limits on patient access to new treatments, drug-safety concerns, mounting clinical-trial disclosure requirements and changes to intellectual-property laws, he said.

"Public policy is often emotion-based. It has less to do with what's the best policy and more with what gets (officials) elected," Badgley said today.

According to the lobbyists, New Jersey's attorney general has formed a task force to investigate the compensation paid by drug and biotech companies to some doctors in the medical community who test new treatments. In Washington state, the legislature has established a board to review a new medical technology or treatment and to recommend whether it should be supported by state employee health coverage.

And in Miami-Dade County, drug-company salespeople who approach Jackson Memorial Hospital's purchasing department must be registered as lobbyists with the county.

"If that would be expanded to other jurisdictions, that would be a nightmare," said Tom Tremble, associate vice president of the Advanced Medical Technology Association, a trade group.

In Washington, D.C., Congress continues to grapple with legislation to create a process to review generic biologics - drugs created from living cells - while the drug industry frets over their safety.

Patrick Kelly, vice president of the Biotechnology Industry Organization, said the trade group doesn't oppose generic biologics. But it wants evidence that the generic is as safe as the original.

It also is asking for 12 years of data exclusivity before turning proprietary information over to a generic maker.

"Without it, the (original drug company) can't recoup its costs," Kelly said today.

The biotech industry has reached some major milestones this year. In the past 12 months, it has brought in $47 billion in venture capital nationally. Among its public companies, its total market capitalization stands at about $500 billion.

The BioFlorida conference, which brings together biotech executives, scientists and others, is being held at the Hyatt Regency Bonaventure in Weston.

During his keynote address to the conference Tuesday, G. Steven Burrill, president of Burrill & Co., a San Francisco-based merchant bank, said the industry and government regulators are sometimes at cross-purposes.

"Government, by and large, is our partner and we have to be better at communicating because those guys don't know what we do," Burrill said.