Drug & Device News

Johnson & Johnson to Pay $52 Million in PA Drug Pricing Dispute

Johnson & Johnson must pay $52 million in damages and penalties after a Pennsylvania judge found the pharmaceutical company falsely reported the prices of its drugs. Pennsylvania Attorney General Tom Corbett announced Dec. 17, 2010, that a Commonwealth Court judge rendered the verdict after a five-week trial in Easton, PA. Johnson & Johnson has been ordered to repay more than $45 million to Medicaid and the PACE prescription drug program for senior citizens, along with more than $6.5 million in civil penalties. In 2004, Corbett's office sued Johnson & Johnson, several of its subsidiaries and 14 other drug companies, alleging they manipulated a pricing benchmark known as the “average wholesale price.” Corbett's office has recovered $49 million so far, and other cases are pending.

Commercial Free Speech Wins Out over Patient and Prescriber Privacy

A divided panel of the U.S. Court of Appeals for the Second Circuit has determined that Vermont's prohibition on the sale or use of doctor-identifiable information for drug marketing purposes is an impermissible restraint on commercial speech. The decision invalidates the 2009 law, Vt. Acts No. 80 ' 17 (2007), which the State's legislature enacted to protect the privacy of doctors and patients, whose personal information was being sold by pharmacies to data-mining companies. These companies then extracted the patient-identifiable data, leaving behind information about which medications doctors have prescribed to their patients. With this data in hand, drug manufacturers were then able to better market their products to those doctors. (The law made several exceptions to the rule against providing doctor-identifiable information to entities outside of pharmacies; it allowed the transmission of such records to effectuate the dissemination of recall and safety notices, and allowed it to be used in clinical trials or to aid law enforcement.) Vermont sought the law's restrictions in order to ensure that doctors would prescribe medications based on their merit rather than salesmanship, thus: 1) promoting the integrity of prescribing decisions; and 2) keeping Vermont's costs down, because doctors might, absent strong sales pitches, be more likely prescribe cheaper generic medications for patients whose medical care is covered by the State. The court found in IMS Health Inc. v. Sorrell, 09-1913-cv, however, that the legislation “is a commercial speech restriction that does not advance the substantial state interests asserted by Vermont, and is not narrowly tailored to serve those interests.” In her dissent, Judge Debra Ann Livingston countered that the evidence established “that the harms ' i.e., exorbitant health care costs and threats to patient safety 'are real, and that ' 17, by restricting access to [physician identifiable] data, makes [targeted sales pitches to specific physicians] more difficult and less effective, which, in turn, reduces the pressure on doctors to prescribe more expensive, less proven drugs.”

Blood Glucose Test Strips Recalled

Abbott Diabetes Care has recalled 359 different lots of glucose test strips sold in the United States and in Puerto Rico, marketed under the brand names Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, Optium EZ and ReliOn Ultima. The recalled strips do not absorb enough blood and, consequently, may give falsely low blood glucose readings. This could prompt users to take measures to raise their blood glucose levels when they should not, or could lull those who actually have high glucose levels into thinking they are within an acceptable range. The affected test strips were manufactured between January and May 2010 and were sold through retail outlets and online. Consumers may go to www.precisionoptiuminfo.com to learn if their test strips are affected by the recall. For further information, go to: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm237900.htm.

Johnson & Johnson to Pay $52 Million in PA Drug Pricing Dispute

Johnson & Johnson must pay $52 million in damages and penalties after a Pennsylvania judge found the pharmaceutical company falsely reported the prices of its drugs. Pennsylvania Attorney General Tom Corbett announced Dec. 17, 2010, that a Commonwealth Court judge rendered the verdict after a five-week trial in Easton, PA. Johnson & Johnson has been ordered to repay more than $45 million to Medicaid and the PACE prescription drug program for senior citizens, along with more than $6.5 million in civil penalties. In 2004, Corbett's office sued Johnson & Johnson, several of its subsidiaries and 14 other drug companies, alleging they manipulated a pricing benchmark known as the “average wholesale price.” Corbett's office has recovered $49 million so far, and other cases are pending.

Commercial Free Speech Wins Out over Patient and Prescriber Privacy

A divided panel of the U.S. Court of Appeals for the Second Circuit has determined that Vermont's prohibition on the sale or use of doctor-identifiable information for drug marketing purposes is an impermissible restraint on commercial speech. The decision invalidates the 2009 law, Vt. Acts No. 80 ' 17 (2007), which the State's legislature enacted to protect the privacy of doctors and patients, whose personal information was being sold by pharmacies to data-mining companies. These companies then extracted the patient-identifiable data, leaving behind information about which medications doctors have prescribed to their patients. With this data in hand, drug manufacturers were then able to better market their products to those doctors. (The law made several exceptions to the rule against providing doctor-identifiable information to entities outside of pharmacies; it allowed the transmission of such records to effectuate the dissemination of recall and safety notices, and allowed it to be used in clinical trials or to aid law enforcement.) Vermont sought the law's restrictions in order to ensure that doctors would prescribe medications based on their merit rather than salesmanship, thus: 1) promoting the integrity of prescribing decisions; and 2) keeping Vermont's costs down, because doctors might, absent strong sales pitches, be more likely prescribe cheaper generic medications for patients whose medical care is covered by the State. The court found in IMS Health Inc. v. Sorrell, 09-1913-cv, however, that the legislation “is a commercial speech restriction that does not advance the substantial state interests asserted by Vermont, and is not narrowly tailored to serve those interests.” In her dissent, Judge Debra Ann Livingston countered that the evidence established “that the harms ' i.e., exorbitant health care costs and threats to patient safety 'are real, and that ' 17, by restricting access to [physician identifiable] data, makes [targeted sales pitches to specific physicians] more difficult and less effective, which, in turn, reduces the pressure on doctors to prescribe more expensive, less proven drugs.”

Blood Glucose Test Strips Recalled

Abbott Diabetes Care has recalled 359 different lots of glucose test strips sold in the United States and in Puerto Rico, marketed under the brand names Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, Optium EZ and ReliOn Ultima. The recalled strips do not absorb enough blood and, consequently, may give falsely low blood glucose readings. This could prompt users to take measures to raise their blood glucose levels when they should not, or could lull those who actually have high glucose levels into thinking they are within an acceptable range. The affected test strips were manufactured between January and May 2010 and were sold through retail outlets and online. Consumers may go to www.precisionoptiuminfo.com to learn if their test strips are affected by the recall. For further information, go to: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm237900.htm.