We're at the Carnegie Endowment for Peace Conference Center in Washington DC today for the first Prescription Project Conference, Righting the Script, Improving Pharmaceutical Policy in an Era of Health Reform, and Congressman Henry Waxman (D-CA) is delivering the keynote address in a few minutes. We'll be live-blogging his address.
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"Chairman Waxman has been a hero to all of us in the health access area," said RxP Executive Director Rob Restuccia as he introduced Rep. Waxman.
"Next January, I'll assume the Chair of Energy and Commerce, " Rep. Waxman began, but turned nearly immediately to his previous role as Chair of the Committee on Oversight and Government Reform, where he said he used oversight to try to "shine a spotlight" on the fraud and abuse in government, or "what happens when our regulatory agencies become politicized, and when politics replaces science."
Waxman talked about the legislation he worked on as 16-year chair of the Commerce committee's Subcommittee on Health & Environment, including:
-Hatch-Waxman Act
-Medicaid price advantage
-national nutrition labeling system
-a childhood vaccine compensation system
-orphan drug legislation
-Ryan White Act, which offer services to AIDS patients
-"now-famous" tobacco hearings
"I've been amused of late, when a lot of people started to speculate about how I would be in legislating," Rep. Waxman said. "I think if people want to know how I'm going to act as Chairman, they should look back to what I did back then as Chair of the Health & Environment subcommittee."
Of his new chairmanship, Rep. Waxman said he'd not move away from oversight: "But that doesn't mean we're not going to look at oversight," he said. "Oversight informs the legislative process."
He said he wants to work with President-elect Obama to pass "affordable, accessible health care coverage for all Americans."
"The opportunity we have now to change this system is the greatest we've ever had," the incoming Chairman said, and mentioned HHS Secretary-appointee Tom Daschle and "a legend" in Sen. Edward Kennedy to help move health reform efforts.
"There are some that say with the economy the way it is, we have to put this goal off," he said. "Well, I look at it completely differently," saying he believes that health reform is even more critical in the current economic climate.
"And to me, the best approach is what we can pass," he said, indicating that President-elect Obama has laid out a "workable blueprint."
He mentioned Congress' immediate health care priorities are to re-enact and expand SCHIP, and offer states Medicaid help. In addition:
-generic biologics
-wants to give FDA authority to regulate tobacco
-offer "support" and "constructive criticism" of public health agencies, who've "too often had their scientific judgment interfered with."
"Americans must face an inconvenient truth about drug safety," he said, and acknowledge that in an effort to get therapies to people, we have to let drugs on the market whose full safety profiles aren't known.
But because companies do such heavy marketing in those first years, Waxman said that dangerous effects can go undetected and spread in wide prescribing, and said he supported legislation that would grant FDA authority to put a moratorium on direct-to-consumer advertising on certain drugs in the first two years on a case-by-case basis.
Rep. Waxman went on to say Congress needs to address physician marketing, because the "most persuasive, effective advertising" really goes on in the doctor's office. He discussed industry's attempts to conduct off-label marketing, cherry-picked industry information, and his support of Kohl's academic detailing initiative, the Independent Drug Education and Outreach Act.
Dr. Daniel Carlat (Carlat Psychiatry Report) asked about support of Physician Payments Sunshine Act, which would require companies to disclose payments to physicians, health care organizations, and other prescribers.
"I was going to ask how you felt about it, as a psychiatrist," Rep. Waxman quipped, and then said he hadn't had a chance to review the legislation, but would take Carlat's recommendation to support it into consideration .
When asked about the "broken agency" reputation of the FDA, Rep. Waxman said he would prefer totally independently funded FDA, instead of reliance on industry user fees, but not if that means an under-funded agency.
Asked what level he hoped to fund the FDA at, Rep. Waxman didn't give a number, but listed authority, funding, and organizational structure as his three strategies for fixing the agency.