Tamper-resistant Rx pads to be used starting in April
WASHINGTON On April 1, 2008, the Centers for Medicare and Medicaid Services regulation requiring the use of tamper-resistant prescription pads for Medicaid beneficiaries will go into effect.
CMS also has made several exceptions to the requirement. Prescriptions for hospital inpatients and residents of long-term care facilities will not be subject to the tamper-resistant prescription pads, but the pads will be required for hospital outpatients and the community retail setting.
Beginning in October 2008, computer generated prescriptions must include features designed to prevent unauthorized copying of a prescription form, erasure or modification of information written by a prescriber; or use of counterfeit prescription forms.
Jury hits AstraZeneca with $215 million fine in price-inflation case
MONTGOMERY, Ala. An Alabama state court jury found AstraZeneca Pharmaceuticals at fault in inflating drug prices charged to the state’s Medicaid program, according to published reports. As a result, the company has to pay $215 million, $40 million in compensatory damages and $175 million in punitive damages.
Alabama claimed in its complaint, filed in 2005, that the companies overstated the average wholesale price of drugs, which is used to calculate Medicaid reimbursement rates to pharmacies.
AstraZeneca said the judge made numerous errors in the trial, which started Feb. 11. Those errors included barring evidence of how pharmacies manage Medicaid drug costs, according to the company.
AstraZeneca lawyer Thomas Christian told the jury in opening statements that state Medicaid officials had a complete understanding of how drug pricing worked. Once a drug was shipped to the wholesaler and then pharmacies, the company had no control over pricing, Christian said. The company plans on appealing the decision.
AstraZeneca is the first of more than 70 drugmakers sued by Alabama to go to trial. GlaxoSmithKline and Novartis Pharmaceuticals are scheduled for trial in April. Takeda Pharmaceuticals North America and Merck’s Dey unit settled pricing claims with Alabama last month for a combined $6.75 million while admitting no liability.
Prasugrel given priority review by FDA
WASHINGTON A new drug, prasugrel, manufactured by Eli Lilly and Daiichi Sankyo, has been granted a priority review by the Food and Drug Administration.
The drug is intended for the prevention of blood clots, and if approved, will be competing against Plavix, the blockbuster drug sold by Bristol-Myers Squibb Co and Sanofi-Aventis. A study conducted in November has already shown that prasugrel was 19 percent more effect than Plavix, but resulted in a higher amount of serious bleeding.
A priority view, according to published reports, means that the FDA will decide within six months whether or not to approve the drug. An approval for a drug usually takes about 10 to 12 months.
The application for prasugrel was filed on December 26, and since the news of its priority view its shares rose up nearly 3 percent. If approved, Lilly plans its drug to be brand named Effient.