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Warm and Fuzzy!
The pharmaceutical industry is paying $13.2 million to run advertisements supporting 28 politicians, all but three of them Democrats, in an example of how interest groups are already adjusting to the prospect of stronger Democratic control of Congress in 2009. Over images of smiling children, the narrator tells constituents to call their lawmakers and "tell them to keep fighting to insure our kids."
The pharmaceutical industry is already switching its lobbying efforts in order to adjust to the prospect of a stronger Democratic control of Congress. These ads thank the legislators for supporting a children's healthcare bill vetoed twice by President Bush in 2007. The group running the campaign says it selected the lawmakers for praise because they were under pressure to switch their votes. Some of them may be playing play key roles in shaping bills that could possibly adversely affect the industry.
The warm and fuzzy ads were produced by the organization (nonprofit) America's Agenda: Health Care for Kids. The group was just organized and started last month with PhRMA as its sole funder. PhRMA has also been collaborating with other formerly adverse groups.
http://online.wsj.com/article/SB122480762067065051.html?mod=dist_smartbrief
J&J&$&Psychiatrists
Johnson & Johnson is responding to the Senate Finance Committee that issued a letter requesting data on "payments or benefits to a number of specified psychiatrists associated with psychiatric professional associations or otherwise authorities in their field." Meanwhile, the American Psychiatric Association said it is working with "other medical societies to develop broader standards for reporting and limiting relationships with industry."
http://www.bloomberg.com/apps/news?pid=newsarchive&sid=ad5S7xv5LKrk
Pre-emption at the Supreme Court
Pharmaceutical companies should not be liable for harm from medicines that carry warnings approved by federal regulators, lawyers for Wyeth told the U.S. Supreme Court on Monday.
The Wyeth v. Levine case was argued in the U.S. Supreme Court recently and Wyeth's lawyers maintained "that all risks were disclosed to the FDA, and that the company was not allowed to make the warning any tougher." The company was required to use the FDA-approved warnings and could not have changed them without the agency's permission.
It was noted that Supreme Court justices expressed skepticism with arguments given Monday by business interests hoping for wide immunity from lawsuits over federally regulated products. "One problem is that "federal law is silent on whether Congress intended to bar state lawsuits over drug labeling, [although] Wyeth contends that such claims implicitly conflict with the FDA regulatory scheme. Because other federally regulated industries are in a similar situation-Congress hasn't indicated whether federal oversight is intended to complement or supplant parallel state laws-business hopes the court will rule in favor of pre-emption that can be applied to other fields."
http://online.wsj.com/article/SB122572239149293091.html
More on Pre-emption
Justice Antonin Scalia appeared to be backing Wyeth's position. "If you're telling me the FDA acted irresponsibly, then sue the FDA," Scalia said. But holding the company liable could lead to manufacturers over-warning about beneficial drugs just to avoid lawsuits, he said.
Justice Ruth Bader Ginsburg seemed concerned that the FDA does not always make the right decision about whether a medicine is too dangerous or has proper warnings, a position argued by Levine's lawyers. "Considering the huge number of drugs, is the FDA really monitoring every one of these?" Ginsburg asked.
The justices are trying to determine whether FDA approval pre-empts state laws and protects companies from legal damages. A decision is expected sometime next year.
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