PHARMACY

FDA, SAMHSA to develop education campaign for methadone

BY Alaric DeArment

ROCKVILLE, Md. A drug used to treat pain and heroin addiction is one of the most-abused prescription drugs in the country, but two government agencies will collaborate to educate the public on how to use it safety.

The Food and Drug Administration and the Substance Abuse and Mental Health Services Administration announced Monday that they would launch a joint education campaign within SAMHSA about the safe use of methadone.

The agencies will hold a press conference Tuesday morning to mark the launch of the program.

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PHARMACY

New Democrat Coalition supports H.R. 1548

BY Alaric DeArment

WASHINGTON Leaders of the New Democrat Coalition voted Thursday to endorse a biosimilars bill introduced as an alternative to a bill that would use the Hatch-Waxman Act of 1984 as a model.

H.R. 1548, the Pathway for Biosimilars Act, introduced by fellow New Democrat Reps. Anna Eshoo of California and Jay Inslee of Washington, would allow a regulatory pathway for biosimilars but allow 14 years of market exclusivity, compared with the five-year period allowed by a bill introduced earlier by Rep. Henry Waxman, D-Calif.

“America’s patients want new cures, and they deserve access to cheaper medicines,” New Democrat chairwoman Rep. Ellen Tauscher of California said. “That’s why the Food and Drug Administration needs the authority to approve follow-on biologics.”

The bill, introduced on March 17, competes with Waxman’s Promoting Innovation and Access to Life-Saving Medicine Act, introduced on March 11, along with a companion bill introduced in the Senate on March 26. The Generic Pharmaceutical Association supports the Waxman bill, while the Biotechnology Industry Organization supports the Eshoo bill.

In other news, Sen. Orrin Hatch, R-Utah, who co-sponsored the Hatch-Waxman Act that made generic pharmaceutical drugs possible, broke with Waxman in telling reporters at drug regulation conference that he and Sen. Ted Kennedy, D-Mass., support longer exclusivity periods for biosimilars, according to published reports.

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FDA approves Johnson & Johnson’s Simponi to treat arthritis

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration has approved a new drug for treating three types of arthritis.

The agency announced Friday that it had approved Johnson & Johnson’s Simponi (golimumab), a once-monthly injection for treating moderate-to-severe rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis, an arthritis of the spine.

“[Today’s] approval provides another treatment option for patients with these three debilitating disorders,” FDA Center for Drug Evaluation and Research Division of Anesthesia, Analgesia and Rheumatology Products director Bob Rappaport said. “And the steps we’re taking to minimize the risks will give patients the same level of safety protection required for other drugs in its class.”

Simponi, a monoclonal antibody made by J&J biologics division Centocor Ortho Biotech, is designed for use in combination with Barr Labs’ immunosuppressant drug Trexall (methotrexate) when treating rheumatoid arthritis, with or without Trexall when treating psoriatic arthritis and alone when treating ankylosing spondylitis.

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