Regulatory and Washington

SYDNEY — Australian drug maker QRxPharma is seeking approval for a drug that combines two painkillers in one pill, the company said Monday.

QRxPharma announced that it had filed a regulatory approval application with the Food and Drug Administration for MoxDuo IR (morphine and oxycodone). The drug is designed to release both drugs into the body immediately.

PHILADELPHIA — The Food and Drug Administration has approved a drug made by Shire for treating ulcerative colitis, the British drug maker said Monday.

Shire announced the approval of Lialda (mesalamine) delayed-release tablets for the maintenance of remission in patients with the disease.

The drug was already approved for inducing remission in patients with ulcerative colitis, an inflammatory disease that affects the colon and causes chronic inflammation, sores and ulcers.

GENEVA — The World Health Organization on Thursday announced 11 new manufacturers of the seasonal flu vaccine, a development that is expected to double the number of influenza doses to 1.7 billion worldwide by 2015, according to published reports. 

In all, there now are 37 approved vaccine manufacturers that potentially could triple their annual production to make as much as 5.4 billion pandemic vaccinations in the event of another H1N1-type outbreak. 

ALEXANDRIA, Va. — Amid debt ceiling talks, the National Association of Chain Drug Stores has sent a letter to President Barack Obama and to the U.S. House of Representatives and Senate leadership outlining key areas to help ensure continued patient access to pharmacy services through such federally funded programs as Medicare, Medicaid and TRICARE, the association announced on Wednesday. 

ALEXANDRIA, Va. — The National Association of Chain Drug Stores announced on Thursday its support of legislation that seeks to repeal a provision of the Patient Protection and Affordable Care Act, which requires consumers to obtain a prescription to use their flexible spending accounts for over-the-counter medication purchases.

The Restoring Access to Medication Act was introduced by U.S. Reps. Lynn Jenkins, R-Kan., and Shelley Berkley, D-Nev., and Sens. Pat Roberts, R-Kan., and Ben Nelson, D-Neb.

WASHINGTON — Four legislators on Thursday introduced legislation that would restore over-the-counter medicines as qualified reimbursements under health spending accounts and flexible spending accounts without a prescription. A provision in the Patient Protection and Affordable Care Act enacted in January had created a prescription requirement in order for OTC medicines to qualify for pre-tax reimbursements. 

ALEXANDRIA, Va. — The U.S. Department of Defense has issued a final rule that, effective Aug. 12, expands the scope of retail pharmacy-provided vaccination services in the TRICARE military healthcare program for the nation’s military, retirees and their families.
 

WASHINGTON — The U.S. Department of Health and Human Services on Monday proposed a framework to assist states in building Affordable Insurance Exchanges, state-based competitive marketplaces where individuals and small businesses will be able to purchase affordable private health insurance.