The PharmaCertify™ Team
Stormy weather! Have you had some? While lightning, high winds and hail are certainly no fun, there are parts of the country that really needed the rain that came with them. If you’re facing another rainy, stormy day, we are thinking of you and have just the ticket to pass the time…this week’s News in Review.
The storm clouds parted for the industry in Texas. The state’s Supreme Court ruled pharmaceutical manufacturers are not responsible for communicating a drug’s risks, even when the drug is marketed directly to patients. The decision overturned a previous appellate court ruling. The case at hand involved a patient who developed a Lupus-like syndrome after taking Remicade. The patient and her husband blame the drug, and say an informational video they watched at a physician’s office did not adequately communicate the risks associated with use of the drug. The Supreme Court ruled that the drug company provided adequate warning information to the patient’s physician, and since the patient had visited with her physician and decided to take the drug prior to viewing the video, there was no need for them to make an exception to the learned intermediary doctrine.
The tempest surrounding the Vermont data mining law may finally have subsided. Following the Supreme Court’s decision that effectively overturned the law, a U.S. District Court for Vermont has decided the state must pay IMS Data $2.4 million in legal fees. The company had asked for just over $4 million in fees, and the state asked that the amount be reduced to just under $1.5 million. The court settled on $2.4 million, bringing the total Vermont has had to pay to $4.1 million ($1.7 million went to PhRMA).
The time for has come for Travelers Insurance to put up that umbrella of theirs. Cephalon has brought suit against the insurer to stop them from attempting to recover $17.4 million the company claims it paid to cover off-label prescriptions for a cancer pain medication. Cephalon says federal law provides the FDA with the authority to deal with off-label promotion and does not give Travelers the right to file a suit.
Rounding out the litigation round-up, a new suit has been filed against Abbott related to off-label use of an anti-seizure medication. Plaintiffs claim the manufacturer failed to provide adequate warning on the product’s label regarding the risk of birth defects if women use the drug while pregnant.
China’s data privacy laws are leaving companies stranded in the rain during an FCPA investigation. A survey of FCPA compliance professionals reveals that the laws are impeding investigations into possible violations of the FCPA. Chinese data privacy law is very strict when the document in question could be categorized as a state secret. Experts say that since China so broadly defines a “state secret,” examining documents outside the country’s borders is difficult.
The pharma industry in India has decided to not fight the winds of change, and, in principle, has agreed to enforcement of the Department of Pharmacy’s marketing code. A representative of one of the country’s industry groups said a few companies have blemished the reputation of the entire industry. The Department of Pharmacy has agreed to make the code more practical and implementable. The code could be in place by the end of the year.
Well you’ve reached the end of this week’s Review! Is the rain still falling in your neck of the woods? Look on the bright side, all that rain gave you a good excuse for not doing any yard work during the weekend. Stay dry and have a great week everyone!