Compliance September 28, 2005

VT Loses Rx Drug Importation Fight

September 28, 2005 (PLANSPONSOR.com) - Vermont's lawsuit against the federal Food & Drug Administration (FDA) over its imported prescription drug policy has been thrown out.
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BNA reports that US District Judge William Sessions, III of the US District Court for the District of Vermont dismissed the suit, saying the FDA did not act improperly in denying Vermont’s petition to allow it to set up a drug importation plan that would import cheaper drugs from Canada since drug importation is illegal under federal law.

The judge said in his opinion, according to BNA, that, in addition to being illegal under the Federal Food, Drug, and Cosmetic Act, the Medicare Prescription Drug, Improvement and Modernization Act (MMA) does not provide authorization for Vermont’s plan since the secretary of the Department of Health and Human Services (HHS) has not certified to Congress that importation is safe and effective, which is a prerequisite to importation under the act.   The court rejected Vermont’s argument that the certification required by MMA was only intended to apply to commercial importation rather than importation by individuals.

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In addition, BNA reports, the court rejected the argument that the certification provision was unconstitutional since it improperly delegates legislative power to the executive branch.   Sessions also found that the HHS secretary had not unreasonably delayed action on the certification provision of MMA.

The suit filed in August 2004 was the first move by a state to sue the federal government regarding importation of prescription drugs (See  Vermont Sues FDA Over Drug Importation ).   The FDA had denied  Vermont’s December 4, 2003 citizen petition requesting FDA’s permission to establish a program for the importation of prescription drugs from Canada, BNA reports.   The state sought a court order requiring “prompt adoption of regulations and waiver guidance and appropriate consideration of Vermont’s proposed program.”

The opinion was issued in re: Vermont v. Leavitt, D. Vt., No. 2:04-cv-00206 (WKS), 9/19/05.

Despite the legality of the issue, many states have already passed measures to allow importation of prescription drugs from Canada and other countries (See  Illinois Becomes Fifth State to Import Prescription Drugs from Abroad ).

Benefits September 27, 2005

EEOC Sues AZ Paving Firm over Sex Harassment

September 27, 2005 (PLANSPONSOR.com) - An Arizona firm has been slapped with a federal lawsuit over charges that a supervisor harassed male workers by grabbing their genitals, simulating sex acts, and attempting to kiss them.
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The US Equal Employment Opportunity Commission (EEOC), which filed the suit in US District Court in Tucson against the Phoenix-based Sunland Asphalt, charged that another employee exposed himself while still another worker urinated on his co-workers, according to the Arizona Daily Star. The company is a paving contractor.

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The alleged harassment and retaliation began in 1999 and continued through at least 2002, said Michelle Marshall, an EEOC lawyer who filed the lawsuit. The incidents, which involved Tucson-based employees, happened mostly in Tucson but may have also occurred at a job site in Nevada, she told the Star.

The allegations are overstated, Sunland vice president Mike McWenie told the newspaper. He said the allegations stem from just one incident that occurred in 1999. “I can’t comment on any of the details or the personalities involved. All I can tell you is that we feel like we have complied with all federal and state laws on this,” McWenie told the newspaper. “This is something that happened well over two years ago. I’m at a loss. I’m baffled it has come to this.”

The EEOC has asserted that employees who filed complaints were forced to quit because the harassment was severe and supervisors were unwilling to correct improper behavior. When one employee, also seeking a promotion, complained about the harassment, a supervisor told him “you can forget about becoming foreman,” according to the lawsuit.

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