FDA approves expanded use of Xifaxan
SILVER SPRING, Md. The Food and Drug Administration has approved a new use for a drug made by Salix Pharmaceuticals, the FDA announced Wednesday.
The agency approved Salix’s Xifaxan (rifaximin) for treating hepatic encephalopathy, a deterioration in brain functioning in patients with liver disease that results from the liver’s no longer being able to clear toxins from the body.
The drug already had approval for treating traveler’s diarrhea.
“The approval of Xifaxan for this new indication provides an additional treatment optin for patients with liver disease,” FDA Division of Gastroenterology Products deputy director Joyce Korvick said in a statement. “Hepatic encephalopathy occurs commonly in patients with liver disease, and there are few effective treatments for this serious condition.”
Head of NCPA to step down
ALEXANDRIA, Va. Bruce Roberts will step down as EVP and CEO of the National Community Pharmacists Association this summer, the NCPA announced Wednesday.
Roberts, who has served as the head of the group for eight years, said he would step down on June 25.
“After nearly nine years at the helm of NCPA, the time seems right to turn over the reins of the association,” Roberts said in a statement. “I’m proud to have led a team that has done so much to position community pharmacy in a more favorable light in our healthcare system. The stronger voice we’ve developed for NCPA in the political arena is producing policies that help local pharmacists continue to care for their patients. With NCPA on solid footing and well positioned to do great things in the coming years, I have decided it’s time for me to move on to the next chapter.”
SVP and COO B. Douglas Hoey has been designated to serve as acting EVP and CEO after Roberts leaves and until a replacement is found. Roberts will go on to become president and CEO of BeneCard PBF, a “prescription benefit facilitator” that bills itself as an alternative to the traditional pharmacy benefit manager model.
“Bruce Roberts’ vision and passion for independent community pharmacy have greatly benefited NCPA members, and his service has been deeply appreciated,” NCPA president Joseph Harmison said. “Bruce helped NCPA develop into both an extremely effective advocate for community pharmacists as well as a source of market-oriented solutions to support our members.”
Bill would prohibit federal PBM contracts with companies operating PBMs, retail pharmacies
WASHINGTON A bill to reform pharmacy benefit managers made headway in the House Wednesday as a subcommittee vote sent it to the Committee on Oversight and Government Reform.
The Federal Workforce, Postal Service and District of Columbia Subcommittee voted Wednesday to send H.R. 4489, the FEHBP Prescription Drug Integrity, Transparency and Cost Savings Act, to the full committee. The bill was introduced in January by Reps. Stephen Lynch, D-Mass., Gerry Connolly, D-Va., and Elijah Cummings, D-Md.
Current law prohibits companies that own a PBM and manufacture drugs from doing business with FEHBP health plans, but the bill would extend that restriction to companies that operate PBMs and own retail pharmacies; one such company is CVS Caremark, one of the largest PBM contractors for the FEHBP. CVS Caremark has a contract with the FEHBP that will last until the end of 2011.
“The legislation proposed by Congressman Lynch would not benefit plan participants, the plans themselves or taxpayers, but would instead reduce the number of competitors for the program and thus increase costs for beneficiaries and taxpayers,” CVS Caremark spokeswoman Christine Cramer told Drug Store News. “In addition, while the bill calls for oversight and transparency provisions, the Office of Personnel Management already has rigorous oversight and transparency requirements and regularly audits PBMs providing services to FEHBP plans.”
The Pharmaceutical Care Management Association, an industry trade group for the PBM industry, also expressed opposition to the bill.
“Seventy-four percent of those enrolled in FEHBP oppose a new effort by Congress to reduce pharmacy choices, arbitrarily set prices and limit the number of pharmacy organizations which can participate in the program,” PCMA president and CEO Mark Merritt said in a statement. “FEHBP enrollees feel that [the Office of Personnel Management] does a great job managing the program and think Congress is more likely to hurt than help the program by forcing OPM to change FEHBP’s pharmacy benefits.”
The bill would also prohibit unauthorized prescription switching by PBMs, require them to return 99% of all drug rebates to the FEHBP and require them to give the Office of Personnel Management full access to certain data and broad auditing rights.