In remarks about his proposed 2007 budget and deficit reduction, President Bush said, "People talked about how the decision to reform Medicaid was immoral. Well, it's not immoral to make sure that prescription drug pharmacists don't overcharge the system.... It turns out that there was inflated markups for people who had government help to buy drugs. That doesn't make sense, so we reformed that. The people are still going to get their drugs, but the taxpayers aren't going to pay inflated prices." Bush's accusation about pharmacy overcharging came the same day HHS secretary Michael Leavitt repeated his praise of R.Ph.s for their "heroic" efforts to help patients get their Medicare Part D drugs.
Bush says cutting Medicaid fees is moral
In remarks about his proposed 2007 budget and deficit reduction, President Bush said, "People talked about how the decision to reform Medicaid was immoral. Well, it's not immoral to make sure that prescription drug pharmacists don't overcharge the system.... It turns out that there was inflated markups for people who had government help to buy drugs. That doesn't make sense, so we reformed that. The people are still going to get their drugs, but the taxpayers aren't going to pay inflated prices." Bush's accusation about pharmacy overcharging came the same day HHS secretary Michael Leavitt repeated his praise of R.Ph.s for their "heroic" efforts to help patients get their Medicare Part D drugs.
NACDS' Fuller blasts 'outrageous'Bush comments
Bush sees R.Ph.s as crooks, says NCPA
George Bush is "basically saying pharmacists are crooks," said NCPA executive VP-CEO Bruce Roberts, R.Ph., in response to the President's remarks. He added that although pharmacy is a small fraction of Medicaid costs, Bush's proposed reimbursement cuts could leave patients without access to pharmacies forced out of the program or out of business. In a letter to Bush, NCPA president James Rankin, R.Ph., called on the President to apologize to R.Ph.s and stop attacking small businesses.
Stronger labeling required for Tequin
Bristol-Myers Squibb has announced stronger warnings for gatifloxacin (Tequin), an antibiotic used to treat various types of infections, because of serious reports of hypo- and hyperglycemia. Most of the episodes occurred in diabetes patients; however, some patients affected did not have a history of the condition. Other risk factors include older age, renal insufficiency, and concomitant glucose-altering medications. Reports of hypoglycemia usually occurred within three days of initiating therapy, while the reported hyperglycemia tended to occur after the third day of treatment. Patients with these factors should be closely monitored, and patients with diabetes should not take Tequin at all, according to the new labeling. The company also warned that it has received postmarketing reports of serious disturbances in glucose homeostasis, including hyper- and hypoglycemic coma and diabetic ketoacidosis. Although most of the reported events were reversible, a few cases resulted in death.
Increased risk with Ortho Evra patch
Ortho-McNeil has released initial findings from two studies evaluating the risk of heart attack, stroke, and venous thromboembolic events (VTEs) in patients using its Ortho Evra birth control patch. One study has found similar risk of VTE between birth control pills (BCPs) and the patch; however, a second study showed a twofold increase for risk of VTE in users of Ortho Evra. The FDA said it will not require any labeling changes at present since the new findings are based on preliminary data. Additional data will be available by May. In November 2005, the company added a bolded warning to the labeling that stated that use of the patch exposes patients to about 60% more estrogen than a typical BCP containing 35 mcg of estrogen. Increased risk of heart attack and stroke does not seem to be associated with use of the patch. However, the FDA said it could take 18 months to examine the incoming data to know this for sure.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.