FDA to enhance warnings on Tussionex
WASHINGTON UCB, the maker of Tussionex cough medicine, has reached out to the Food and Drug Administration to place a stronger warning on the drug. This new push stems from the report of five deaths of young children from taking Tussionex.
According to published reports, the deaths were all children under age 6, but the Belgian pharmaceutical company said that the drug is only to be taken for children and adults ages 6 and up.
Tussionex Pennketic Extended- Release Suspension contains the pain reliever hydrocodone. According to reports, the FDA is planning to issue an alert about the effects of Tussionex.
Pharmacy organizations in California request CMS examination of Medi-Cal cuts
SACRAMENTO, Calif. The National Association of Chain Drug Stores, the California Pharmacists Association and the California Retail Association called on federal regulators Friday to carefully examine a state plan amendment for a 10 percent “across-the-board” cut to Medi-Cal reimbursements.
In a joint letter to the administrator of the Centers for Medicare and Medicaid Services, Kerry Weems, the groups highlighted potential consequences of the reduction, which was enacted last month.
“We urge that CMS ensure that DHCS and the Medi-Cal program have performed their statutorily required due diligence under the Medicaid statute in evaluating the impact of each component provider reduction on beneficiary access. If they have not done so, we urge that the SPA be rejected,” the groups stated.
“Maintaining pharmacy access is important not only to Medi-Cal beneficiaries’ health and safety, but also to the Medicaid program’s overall ability to constrain costs at the ‘macro’ level,” they noted, citing studies that have found reduced access to prescriptions can result in increased emergency room visits and prolonged hospital stays, which are more costly forms of healthcare.
Pharmacies fill over 22 million prescriptions for Medi-Cal patients every year, and NACDS, CPhA, and the CRA represent approximately 5,000 pharmacies operating in California.
“Many California providers—and particularly pharmacy providers—have experienced repeated reductions in Medi-Cal reimbursement over the last few years,” the groups wrote. “[It] it is crucial that any additional cuts be performed in a measured and rational manner that takes beneficiary access levels into consideration. We trust that if the supportive documentation submitted by the state with the proposed SPA fails to meet the federal statutory standard, CMS will reject that submission and insist that the federal standard be met through a provider-by-provider evaluation of beneficiary access levels.”
Merck inks deal to commercialize future Marcadia products
INDIANAPOLIS Marcadia Biotech and Merck have signed a deal under which Merck will help the company test and commercialize its products.
Under the terms of the agreement, Merck will pay Marcadia an initial upfront fee, as well as payments for exclusivity and ongoing research. Marcadia will also be eligible to receive future milestone and royalty payments associated with research, development and commercialization of certain new drugs. Financial terms were not disclosed.
Marcadia does not have any products on the market yet. It is developing a synthetic hormone that will be supplied in an injector pen, making it ready for quick use in emergency treatment of hypoglycemia.