PhRMA Shows Its Committment to Transparency With Revised Principles on Conduct of Clinical Trials

The Pharmaceutical Research and Manufacturers of America (PhRMA) Board of Directors announced yesterday their unanimous endorsement of revised principles to increase transparency in medical research through their newly revised PhRMA Principles of Conduct of Clinical Trials and Communication of Clinical Trial Results.  The revised principles are part of an effort to encourage behavior that benefits the healthcare community and the public through objectivity in research and strengthened transparency in medical studies.

PhRMA states that the Principles of Conduct, which are to take effect on October 1, 2009, will:

Fortify our commitment to patients and healthcare professionals by increasing transparency in clinical trials, enhancing standards for medical research authorship and improving disclosure to manage potential conflicts of interest in medical research.

The pharmaceutical and biotech industries have been under recent pressure to become more transparent, specifically concerning the disclosure and publication of clinical trial results, the disclosure of physician payments/reimbursement for conducting clinical trials, and authorship standards.

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Supreme Court Rules that Preemption Does Not Exist in Drug Labeling Case

Photo by Magnus Manske via Wikipedia Commons

The Supreme Court held today, in a 6-3 decision, that FDA federal approval of drug warning labels does not preempt state regulations and therefore does not prohibit claims of insufficient drug warnings brought under state law.  The ruling in Wyeth v. Levine upheld a $6.7 million award to Diane Levine, whose arm was amputated after a flawed injection of Wyeth’s anti-nausea drug, Phenergan.

The case centered on the drug’s labeling, as Ms. Levine argued that the label did not warn of the risks associated with administering the drug through “IV push” and that it must contain these warnings in accordance with Vermont law.   The NY Times reported that Wyeth wrote in their brief that they “could not change Phenergan’s labeling to comply with Vermont law without violating federal law.”   They argued that because the drug label was approved by the FDA, a federal agency, Levine’s state law claims were preempted by federal regulations.  The Supreme Court disagreed with this argument, holding that Wyeth could have complied with both state and federal regulations, and reaffirmed the ruling of the Vermont Supreme Court.

Senate Judiciary Committee Chairman Senator Patrick Leahy (D-Vt.) filed an amicus brief for this case in August, 2008.  Today he issued the following statement regarding the Court’s decision:

This decision to uphold the Vermont Supreme Court’s ruling in Wyeth v. Levine has far-reaching effects on the ability of countless Americans to seek justice in their courts. Diana Levine’s life and career have suffered irreparable - yet preventable - damage. The Court’s decision soundly rejects the anti-consumer position of the Bush administration, and reaffirms Congress’ primacy concerning the extraordinary power to preempt state law. Most of all, the decision reclaims for all American citizens the ability to seek justice in their courts of law.

In the 110th Congress, the Senate Judiciary Committee held several hearings to examine the way in which federal agencies have overstepped their authority in the area of preemption, and, given what I viewed as an untenable position by the drug maker and the former administration, I filed an amicus brief with the United States Supreme Court in Ms. Levine’s case. I am gratified that the Court has spoken so clearly on this issue. While recent Supreme Court decisions have shielded big business from accountability and have undermined stronger state consumer protections, this ruling alters that earlier course and affirms that Congress never intended to preempt state laws in the way claimed by Wyeth and the Bush-Cheney administration, claimed. This is a clear victory for Ms. Levine, and for all American consumers. It is also a clear vindication for our own laws and courts in Vermont.

Wyeth’s comments on the decision can be found here.