A Maryland U.S. District Court has denied GlaxoSmithKline's motion for a preliminary injunction to set aside the FDA's decision to approve fluticasone propionate nasal spray, the generic version of Flonase. The court also lifted the suspension of the FDA's approval of a generic version of the spray, and the temporary restraining order previously granted to Glaxo was allowed to expire.
The Oklahoma Senate passed a bill to allow state pharmacies and wholesalers to reimport drugs from Canada, Switzerland, and European Union countries. The bill also requires the pharmacy board to certify foreign suppliers that meet certain conditions such as allowing board inspections and reviews of their safety protocols.
Medicare beneficiaries should be wary of phone callers asking them for bank account information in order to help them enroll in a Part D plan, CMS warned. The scheme is called the "$299 ring" for the amount of money beneficiaries are typically scammed into withdrawing to pay for the fictitious drug plan.
Legislators in Kansas and Nebraska have introduced bills to tighten regulation of drug wholesalers, a move supported by pharmacy associations and state pharmacy boards. The Kansas legislation would require licensure of the nearly 700 wholesalers doing business in the state and institute other drug supply safeguards.
For diabetic patients reluctant to use insulin for fear of daily injections, their prayers may have been answered. Following years of setbacks and delays, the first new insulin delivery option in more than 80 years, Exubera (insulin human [rDNA origin]) Inhalation Powder from Pfizer Inc., received Food & Drug Administration approval in late January for the treatment of adults with Type 1 and Type 2 diabetes.
The American Association of Colleges of Pharmacy joined Univision and the American Association of Colleges of Nursing to sponsor a free brown bag review and health screening for Latinos in San Antonio. Pharmacists and pharmacy students conducted the drug reviews and helped nurses screen for glucose, cholesterol, body mass index, and blood pressure.
The specialty pharmacy Assured Pharmacy has teamed with AnazaoHealth Corp. to offer its customers compounded drugs with overnight courier delivery. Based in Tampa, Fla., AnazaoHealth specializes in nuclear and pain management drugs, as well as drugs for clinical trials, using USP's Chapter 797 sterile compounding standards.
At the request of the FDA, U.S. marshals seized dietary supplements containing ephedrine alkaloids at facilities operated by Hi-Tech Pharmaceuticals in Norcross, Ga. The marshals seized more than 200 cases of finished product sold as Lipodrene, Stimerex-ES, and Betadrene, more than 200 boxes of bulk tablets, and nine 25-kilo drums of ephedrine alkaloid raw material.
CMS is considering changing the date when new Part D enrollments received late in the month become effective. Beneficiaries who sign up late in the month may not have an Rx card or be entered in the eligibility database, causing delays and confusion at the pharmacy counter.
CMS has updated the Part D performance standards for 2007 to require drug plans to operate a toll-free pharmacy technical help call center that is open for the entire period during which network pharmacies in their service areas are open. Thus, if a network includes pharmacies open 24 hours, the plan's technical help desk must also be open round-the-clock.
Long-term care pharmacy providers and consultants rated Pfizer as the drug company with the promotional activities that best met their needs with regard to Medicare Part D prior to implementation of the drug benefit. Johnson & Johnson, Forest, Novartis, and Amgen rounded out the top five in Verispan's Fall 2005 nursing home promotional audit.
Legislators in Kansas and Nebraska have introduced bills to tighten regulation of drug wholesalers, a move supported by pharmacy associations and state pharmacy boards. The Kansas legislation would require licensure of the nearly 700 wholesalers doing business in the state and institute other drug supply safeguards.
A citizen's petition has been filed with the FDA calling for a phased withdrawal of propoxyphene-containing drugs due to their toxic side effects. The group responsible for the move, Public Citizen, said that the risks associated with the painkiller—including the conversion of the drug to a toxic metabolite that leads to cardiac depression—far outweigh the benefit.
An Instant Poll on Drug Topics' Web site, posted in February, found that most respondents think that Tysabri (natalizumab, Biogen Idec) should be brought back to the market. Out of 145 people who voted, 68% said the multiple sclerosis agent should be brought back but with new warnings added, 16% said it should be restored with no new restrictions added, only 10% said it should not be returned to market, and 6% said they didn't know whether FDA should let it come back.
Ever since the sole U.S. manufacturer of varicella zoster immune globulin (VZIG) discontinued its production in October 2004, supply has dwindled to the point of depletion. This February, however, an investigational VZIG product, called VariZIG, has become available under an investigational New Drug Application (IND) for patients who have been exposed to varicella and are at increased risk for severe disease and complications.
Sanofi-Aventis has announced that Apidra (insulin glulisine [rDNA origin] injection) is now available for the control of hyperglycemia in adult patients with Type 1 and Type 2 diabetes. Apidra is a rapid-acting insulin with an onset and duration of action that are faster and shorter than those of regular human insulin.
Specialty pharmaceutical company Santarus has received FDA approval for immediate-release proton pump inhibitor Zegerid. The new product contains omeprazole and sodium bicarbonate in 40 mg/1100 mg and 20 mg/1100 mg combinations.
Hanford Pharmaceuticals is voluntarily recalling four lots of Cefazolin for Injection, USP, 1 gm/10 ml vials due to contamination of the active ingredient by Bacillus pumilus, Staphylococcus hominis, Propionibacterium acnes, or Micrococcus luteus. The affected vials were distributed by Sandoz (lots C4650, C4537) and Watson Pharmaceuticals (lots C4689, C4665) and should be promptly returned to Hanford.
Coverage for psychotropic drugs under Medicare Part D is under fire. The goal of covering all or substantially all products and providing appropriate care for all patients is not being met.
As if the cash flow problems many pharmacists are experiencing lately due to Medicare Part D aren't bad enough, President Bush just delivered another sucker punch to the nation's drug professionals. He signed the budget reconciliation bill, which cuts Medicaid reimbursement to pharmacies for generic drugs by a whopping $6.3 billion over the next five years.
Nearly all persons enrolled in Medicare Part D prescription drug plans (PDPs), except those with the most generous subsidies or those in high-end plans, are subject to co-pays and deductibles. CMS has provided for a central reporting mechanism for recording these out-of-pocket expenditures. The amount a beneficiary must spend on Part D drugs to reach the catastrophic coverage provision is being called "true out-of-pocket," or TrOOP, expenditure. In 2006, persons covered by a PDP are eligible for catastrophic coverage after they have paid $3,600 in TrOOP cost. The threshold can change annually as provided by the Medicare Modernization Act (MMA).
Lou Spadafora, co-owner of Midland Pharmacy on Staten Island, N.Y., bounced a check for $51,000 last month. The pharmacy's bank account was $2,000 short of covering the check. It wasn't the first check he bounced, because he serves a lot of dual eligibles in group homes who were switched from Medicaid to Medicare Part D.
The Food & Drug Administration recently approved sunitinib (Sutent, Pfizer) for the treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib (Gleevec, Novartis). Sunitinib was also granted accelerated approval for the treatment of metastatic renal cell carcinoma (MRCC). This is the first time that the agency has approved an oncology drug for the treatment of two indications simultaneously.
In an attempt to eradicate hepatitis B virus (HBV) from the United States, the Centers for Disease Control & Prevention Advisory Committee on Immunization Practices (ACIP) issued updat-ed guidelines for vaccination against the disease.
The American Heart Association (AHA) estimates that approximately 6.6 million Americans are affected with chronic angina.
Pharmacies already reeling from the botched implementation of Medicare Part D took another body blow Feb. 1, when Congress narrowly approved federal Medicaid reimbursement cuts of $3.6 billion over the next five years. Just five days later, the Bush Administration's new budget proposed lopping an additional $1.3 billion from Medicaid reimbursement.
Pharmacies that want to pull out of Medicare Part D should check the fine print of their drug plan network contracts.
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.
The HealthWell Foundation, a nonprofit organization that assists indigent patients in meeting their cost-sharing obligations for Rx medications, has launched four new programs to help patients afford the medical treatments they need. The new programs will assist patients with colorectal cancer, moderate to severe asthma, non-small cell lung cancer, and non-Hodgkin's lymphoma.