Regulatory and Washington

SEATTLE — The American Pharmacists Association has teamed up with the Cardinal Health Foundation to fight against prescription drug abuse through several initiatives.

With funding support from the Cardinal Health Foundation, APhA members will take an active role in preventing the abuse and misuse of prescription medications, including the following initiatives:

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 — The American Enterprise Institute for Public Policy Research on Monday published a working paper that identified $329 million in overspending as a result of underutilization of generics.

As total spending on 20 medicines with generic equivalents totaled approximately $1.5 billion, AEI concluded Medicaid overspent by 22% ($1.5 billion versus $1.17 billion) on these pharmaceuticals.

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.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Thursday spoke out against a Florida bill sponsored by state Rep. Rob Schenck, R-District 44, which would restrict the dispensing of controlled substances on Schedule II and III to publicly traded pharmacy chains and pharmacies that have more than $100 million in taxable revenues, or only those independent community pharmacies that have been in business more than 10 years.

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.