August 15, 2008
In May 2008, Merck entered into a $58 million, 29-state Vioxx settlement. Payouts begin in August 2008. The settlement’s terms can be divided into three categories: those that confer new rights on state Attorneys General, those that narrow Merck’s right to commercial speech, and those that address conflicts of interest.
The AGs’ New Rights to Enforce Food and Drug Laws
In the settlement agreement, Merck agrees to refrain from making false, misleading, or deceptive promotional claims, and to comply with the Federal Food, Drug, and Cosmetic Act (“FFDCA”) and FDA advertising and promotional requirements. In a novel development, the settlement’s terms allow state Attorneys General—not merely the FDA—to enforce the FFDCA and the FDA’s regulations regarding Merck’s promotional statements.
Merck must also register and submit clinical trial results to the clinical trial registry and results data bank created by the Food and Drug Administration Amendments Act of 2007 (“FDAAA”). The participating state Attorneys General will be able to prosecute Merck for failure to comply with its clinical trial posting duties. Whether this settlement agreement will abrogate the FDA’s fundamental principle of FDA enforcement discretion
remains to be seen.
Voluntary “Prior Restraints”
The settlement’s terms also effectively cede Merck’s control over all Directto-Consumer (“DTC”) advertising for seven years. The FDA will review all of Merck’s proposed advertisements, and Merck must accept any changes the agency requires. Additionally, Merck agreed to comply with any FDA requirements postponing television advertisements for newly-approved pain relievers, effectively creating a voluntary “prior restraint” on Merck’s DTC advertisements.
Congress has been pushing the pharmaceutical industry to voluntarily concede to a DTC television advertising moratorium. In addition, Congressional Democrats recently tried to pass a more tailored law banning DTC drug advertisements for three years after a drug’s approval. They are expected to make a similar push later this year. This settlement may be an effective alternative strategy for pending and future investigations, given that a direct legislative ban on DTC advertising would almost certainly fail First Amendment scrutiny.
Conflicts of Interest
The settlement agreement governs conflicts of interest on Merck’s external Drug Safety Monitoring Board (“DSMB”). Those with financial conflicts of interest are barred from serving on DSMBs for Merck. Other disqualified persons include those with “emotional involvement in the trial,” “intellectual conflicts,” and “career involvement” with the project.
The settlement agreement regulates apparent conflicts of interest in Continuing Medical Education (“CME”). First, Merck must comply with the Standards for Commercial Support adopted by the Accreditation Council for Continuing Medical Education. Most large drug companies currently abide by these standards. Second, Merck must require its promotional speakers to disclose the specifics of their promotional relationship with Merck to CME providers and attendees. Third, Merck may not fund any CME program if Merck knows that any speaker at the CME event has promoted the drugs to be discussed at that program within the last year. The third provision is particularly unusual for the pharmaceutical industry, where some of the most qualified CME speakers also work as drug company promoters.
Finally, any authors on Merck-sponsored manuscripts for Merck-sponsored studies must fulfill three conditions: (1) having made a substantial contribution to the data; (2) having involvement in drafting or revising the article’s “important intellectual content;” and (3) having possessed “final approval rights” over the published version. Those accepting direct responsibility must be identified.
Thus, Merck’s settlement is ground-breaking in at least ways. Primarily, state Attorneys General have the right to enforce FDA regulations. Second, the settlements terms enforce voluntary “prior restraints” on Merck, which are immune from Constitutional challenge. Finally, Merck’s conflict-of-interest controls are almost entirely new in the pharmaceutical industry.
For further information on the Vioxx litigation, please click here to read an article by Jennifer Wolsing.