Biotech industry facing closer scrutiny
Palm Beach Post Staff Writer
Thursday, October 18, 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 here Wednesday 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.
Forty-six states, including Florida, enacted "anti-industry" legislation last year, said Christopher Badgley, vice president of the Pharmaceutical Research and Manufacturers of America.
The industry faces drug-price controls, limits on patient access to new treatments, drug-safety concerns, mounting clinical-trial disclosure rules 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," he said.
According to the lobbyists, New Jersey's attorney general has formed a task force to investigate compensation drug and biotech companies pay to some doctors who test new treatments. In Washington state, the legislature 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, lobbyists said.
"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, 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 group doesn't oppose generic biologics. But the group 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.
The biotech industry 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 industry and government regulators sometimes are at cross-purposes, G. Steven Burrill, president of Burrill & Co., a San Francisco-based merchant bank, said during his keynote address to the conference at the Hyatt Regency Bonaventure on Tuesday.
"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.