Compounded meds legislation introduced in House
WASHINGTON — Two lawmakers recently introduced legislation that aims to make compounded medications more accessible to patients. Reps. Morgan Griffith, R-Va., and Henry Cuellar, D-Texas, introduced HR 2871, the Preserving Patient Access to Compounded Medications Act of 2017.
The act would clarify the Drug Quality and Security Act in a way that would align the statute with congressional intent to balance the issues of public safety and patient access. The bill’s introduction has been praised by pharmacy organizations.
“NCPA supports Congress’s efforts to assure appropriate oversight of compounding pharmacies in a way that does not curtail or hinder patient access to those specially-tailored medications,” National Community Pharmacists Association CEO Doug Hoey said. “When the Drug Quality & Security Act (DQSA) became law in 2013, we and our coalition partners turned our attention to the implementation process.”
In addition to NCPA, the International Academy of Compounding Pharmacies applauded the move.
“IACP consistently has said that maintaining access to potentially life-saving compounded medications is not only vital for patients; but, is consistent with the legislative intent of the DQSA,’ the IACP said. “While reinforcing Section 503A of the Food, Drug and Cosmetic Act through the passage of the DQSA, Congress came together in a bipartisan and bicameral fashion to make clear that pharmacists’ ability to provide compounded medications for a physician’s administration to or treatment of a patient within their practice should be left to the states.”
Hoey said, “This common-sense, bipartisan legislative fix should be supported in the House of Representatives and a companion bill should be introduced in the Senate.”
Adamis gets FDA OK for pre-filled epinephrine syringe
SILVER SPRING, Md. — The Food and Drug Administration last week approved Adamis Pharmaceuticals’ Symjepi, a pre-filled dose syringe of epinephrine. The syringe is indicated for emergency treatment of allergic reactions, including anaphylaxis.
“With an anticipated lower cost, small size and user-friendly design, we believe Symjepi could be an attractive option for a significant portion of both the retail (patient) and non-retail (professional) sectors of the epinephrine market,” Adamis president and CEO Dennis Carlo said. “We are currently in the process of exploring all of our commercialization options and in discussions with potential partners in order to facilitate broad patient access to this new epinephrine treatment option and to maximize the value of our important asset.”
The company said that it’s expecting a launch in the second-half of 2017, and that it has already submitted an application to the FDA for a junior version of Symjepi.
“ We are committed to helping patients by providing them with additional therapeutic choices,” Carlo said.
Teva launches generic of Skelaxin
NORTH WALES, Pa. — Teva has introduced its generic of Skelaxin (metaxalone) tablets, the company announced Tuesday. The drug is indicated as an adjunctive therapy to relieve discomfort associated with acute, painful musculoskeletal conditions.
“Our customers count on Teva for a continuous supply of new generic products,” Teva COO North American generics Maureen Cavanaugh said. “With the launch of metaxalone tablets, we add another quality product to our broad line of affordable generic pharmaceuticals.”