FDA to review patch for HIV-related pain
SAM MATEO, Calif. — A Food and Drug Administration expert panel will review a drug made by NeurogesX as a potential treatment for pain associated with HIV.
NeurogesX said Thursday that the FDA Anesthetic and Analgesic Drug Products Advisory Committee would meet on Feb. 9, 2012, to review the patch drug Qutenza (capsaicin) as a treatment for pain associated with HIV-associated peripheral neuropathy, or HIV-PN.
The drug currently is approved for treating pain associated with postherpetic neuralgia.
NeurogesX filed with the FDA for approval of the drug last month, and the agency expects to decide whether to approve it in early March. While the FDA usually follows the recommendations of advisory committees, it is not bound by them.
NACDS, NCPA commend Reps. Rogers, Braley for concern over draft FUL lists
ALEXANDRIA, Va. — The National Association of Chain Drug Stores and National Community Pharmacists Association issued a statement on Thursday announcing that they commend Reps. Bruce Braley, D-Iowa; Mike Rogers, R-Mich.; and 38 of their colleagues who expressed concerns with draft Federal Upper Limits lists that recently have been published by the Centers for Medicare and Medicaid Services.
“We are concerned that these lists contain flawed information that is not reliable for use in establishing pharmacy reimbursement in Medicaid. We ask that you direct states not to use these draft lists for reimbursement purposes until they can be improved and finalized through a formal notice of proposed rule,” the members of Congress wrote in a letter to CMS.
NACDS and NCPA also have expressed concern with the draft FUL lists in written comments to CMS. “We are heartened that our arguments have been given further credibility by a large bipartisan group of representatives,” stated NACDS president and CEO Steve Anderson and NCPA CEO B. Douglas Hoey. “We want to especially thank Representatives Braley and Rogers for their leadership on this important issue.”
In addition to urging CMS to cease publication of draft FUL lists until a final AMP rule is in place, the representatives also urged the agency to be mindful of comprehensive pharmacy reimbursement. “When setting pharmacy reimbursement rates, both components of reimbursement — product cost and cost to dispense — must be taken into consideration when determining whether pharmacies are paid adequately,” the members of Congress wrote.
Click here to view the Braley-Rogers letter.
GPhA proposes new initiative to target drug shortages
WASHINGTON — The Generic Pharmaceutical Association proposed Thursday the creation of a new initiative to combat the problem of drug shortages.
Calling it a multistakeholder initiative to accelerate the recovery of critical drugs in short supply, the GPhA said the Accelerated Recovery Initiative would call for an independent third party to gather current and future supply information from stakeholders for products; use the information to identify current and potential supply gaps, focusing on products with an expected shortage time longer than 90 days; and involve a high-level "SWAT team" within the Food and Drug Administration to respond quickly to shortages.
The ARI would bring together manufacturers, wholesalers, distributors, group purchasing organizations and the FDA.
"The generic industry has taken a leading role in responding to this crisis, and the ARI marks a significant step in those efforts," GPhA president and CEO Ralph Neas said. "This type of multistakeholder collaboration is exactly what is required to respond to this crisis. While this remains a complex issue that cannot be solved overnight, the ARI would significantly enhance our ability to reverse the drug shortages currently afflicting patients and prevent further ones from occurring."