Well, William and Catherine got to the church on time this morning in England, and what a lovely wedding it was. Best wishes to the happy couple. Now that the obligatory royal wedding reference is out of the way, onto the compliance news week in review.
The big news of the week was the presentation of arguments before the U.S. Supreme Court regarding Vermont’s data mining law. The case, Sorrell v. IMS Data Inc., centers on whether the law violates IMS’s first amendment right to free speech. The state of VT contends that the prescribing information IMS sells to pharmaceutical companies ultimately causes the state to pay higher healthcare costs by having to pay for high priced branded prescription drugs (um…okay), and hence the law prohibiting the sale of this data.
The Supreme Court is expected have a decision in the case in June. In the mean time, Vermont Law School professor, Cheryl Hanna, has an interesting perspective on the case. She asserts the state doesn’t stand much of a chance as the law itself is full of problems. Even those justices one would presume to be more receptive to the state’s argument expressed concerns with the intent of the law.
Also on the state law front is the news that the Massachusetts House voted to repeal the state’s gift ban to physicians (and the restaurant industry said “Amen!”). Proponents of the repeal say the ban has done nothing to lower healthcare costs, has driven away medical meeting business and halted the growth of businesses in the state. Those in favor of keeping the ban dispute the notion that the law stymied growth, and argue that the law is needed to prevent conflicts of interests. Now it’s up to the MA Senate to decide if the law should be repealed.
Obviously, state laws continue to impact the pharmaceutical industry. We can help you keep your team up-to-date on these laws with our State Reporting and Disclosure Laws training module.
A couple of settlements were announced this week. The first was by the wholesaler, Cardinal Health. Cardinal agreed to pay $8M to settle allegations of violations of the federal Anti-kickback Statute. Brought by former pharmacy owner (and ex Kansas City player), Daniel Saleaumua and consultant Kevin Rinne. Saleaumua claims that Cardinal Health paid him $440,000 in exchange for an agreement to purchase drugs for his pharmacy from the wholesaler. Apparently, the government pays almost as well as Cardinal. The two whistleblowers will share an award of $760,000. Par Pharmaceuticals also announced that it had reached a settlement in principle, for $154M, to resolve claims related to price reporting in a case brought by Ven-A-Care Pharmacy. Par is just one of several manufacturers named in the Ven-A-Care suit.
As most of you know, earlier this month the CEO of Forest Labs received a letter from the OIG saying it intended to exclude him from participating in the federal healthcare programs. If the exclusion is enacted, the CEO will need to leave the company in order for Forest Labs to continue to participate in federal healthcare programs. The Wall Street Journal (subscription may be needed) reported this week that the exclusion is based on a little-used executive policy in the Social Security Act, which allows the government to exclude executives of healthcare companies found guilty of misconduct. The executive does not have to have been involved in, or even be aware of, the misconduct, in order for the policy to be enacted. The letter came on the heels of Forest’s final settlement with the government over marketing practices related to two of its antidepressants. The CEO was not alleged to have done anything wrong during that investigation.
This week also marked the start of the trial for an ex-GSK lawyer accused of obstruction, making false statements and falsification of documents related to an FDA inquiry into promotional practices of GSK’s drug Wellbutrin SR . During the opening arguments, the prosecutor categorized her as a lawyer who went too far in protecting her client. The defense argued that she acted in good faith in responding to the inquiry.
Since we led off this week’s wrap up with a mention of the royal wedding, we’d be remiss in not reminding everyone of some fireworks occurring on our country’s shore; the final launch of the space shuttle Endeavor. Sadly, today’s launch was scrubbed, but it is tentatively scheduled for Monday. The Endeavor mission will mark the second to last mission for the space shuttle program. Good luck and Godspeed to the crew!
That’s our news for the week. Until next week, follow us on Twitter for daily news postings and visit us at www.pharmacertify.com to learn more about our off-the-shelf and custom compliance training solutions.