Content about Regulatory and Washington

ALEXANDRIA, Va. — The National Association of Chain Drug Stores has hired Julie Philp as director of federal affairs to bring additional pharmacy and legislative expertise to the government affairs team. She joins NACDS on April 11.

"Julie is a seasoned advocate with experience in pharmacy and on Capitol Hill, and she will bring a wealth of expertise to NACDS," stated NACDS president and CEO Steve Anderson. "NACDS members will enjoy working with Julie, and we are pleased to welcome her to NACDS' highly effective team."

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic treatment for iron deficiency anemia made by Watson Pharmaceuticals, Watson said Thursday.

The drug maker announced the approval of Nulecit (sodium ferric gluconate complex in sucrose), an injectable and generic version of Sanofi-Aventis’ Ferrlecit.

The drug is used to treat iron deficiency anemia in adults and children ages 6 years and older undergoing chronic hemodialysis and receiving supplemental epoetin therapy.

HYDERABAD, India — Indian generic drug maker Aurobindo has received two approvals from the Food and Drug Administration.

The company said Wednesday that it received approval for galantamine tablets in the 4-, 8- and 12-mg strengths. The drug is a version of Johnson & Johnson’s Alzheimer’s treatment Razadyne; various versions of the drug had sales of $41 million during the 12 months ended in September 2010, according to IMS Health.

SILVER SPRING, Md. — Usually, when the Food and Drug Administration approves a commercial version of a drug, it prohibits compounding pharmacies from producing it, but it’s making an exception in the case of a drug used to prevent premature births.

WASHINGTON — Just two weeks after expressing its discouragement caused by the delayed swipe-fee reform, the National Retail Federation lauded a letter from a coalition of consumer groups that also opposed the delay, which is slated to go into effect this summer.

FORT WASHINGTON, Pa. — McNeil Consumer Healthcare on Tuesday recalled one product lot of the analgesic Tylenol 8 Hour extended-release caplets 150-count bottles distributed in the United States, and three brands at the wholesale level.

“McNeil is taking this action as part of our ongoing surveillance and monitoring efforts that identified a small number of complaints of a musty or moldy odor,” the company stated, specifically referencing only the Tylenol 8 Hour recall. The lot number found on the label on the side of the bottle is ADM074; UPC Code 300450297181.

MENLO PARK, Calif. — Raising Medicare’s eligibility age from 65 to 67 years in 2014 would generate an estimated $7.6 billion in net savings to the federal government, but also would result in an estimated net increase of $5.6 billion in out-of-pocket costs for 65- and 66-year-olds, as well as $4.5 billion in employer retiree healthcare costs, according to a new Kaiser Family Foundation projection of the potential change suggested by several deficit-reduction plans.

WASHINGTON — One could say that a job with the Food and Drug Administration would be the perfect way to get information about upcoming drug approvals and use it to profit handsomely from buying stock in the companies that manufacture the drugs before the information reaches the public.

Of course, the Securities and Exchange Commission would consider that illegal insider trading, as one FDA scientist recently discovered.

ALEXANDRIA, Va. — Looking to further communicate the important role pharmacy plays in the healthcare delivery system, the National Association of Chain Drug Stores president and CEO Steve Anderson ran an opinion column in a "Medication Non-Adherence" supplement published Monday by Mediaplanet and distributed in The Washington Post.

WASHINGTON — Ten states could reap significant savings by increasing the use of generic drugs in their state Medicaid programs, the Generic Pharmaceutical Association said Monday in response to a report by the American Enterprise Institute, a conservative think tank.

The report, “Overspending on Multi-Source Drugs in Medicaid,” by Alex Brill, identified states that overspend the most on their Medicaid programs, with California, Texas and Georgia topping the list.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for late-stage skin cancer, the agency said Friday.

The FDA approved Bristol-Myers Squibb’s Yervoy (ipilimumab) for patients with melanoma that has spread to other parts of the body, also known as metastasis. More than 68,000 new cases of melanoma were diagnosed in the United States in 2010, and about 8,700 died from it, according to the National Cancer Institute, part of the National Institutes of Health.

ALEXANDRIA, Va. — A group representing the nation's community pharmacies has applauded legislation introduced in Mississippi that will increase oversight over pharmacy benefit managers.

The National Community Pharmacists Association lauded Mississippi S.B. 2445 and expressed its support of the bill in a letter to state legislators. The bill, NCPA EVP and CEO Kathleen Jaeger said, "would end the special treatment for out-of-state, mail-order pharmacies and put local Mississippi pharmacists first."