Latebreakers: October 9, 2006

DEA loosens rules on Schedule II prescriptions

DEA recently proposed a rule change that would allow doctors to prescribe up to a 90-day supply of Schedule II controlled substances. The rule must go through a two-month comment period, which ends on Nov. 6, before it can take effect. Schedule II drugs include a wide range of medications such as codeine and OxyContin (oxycodone, Purdue Pharma). The Controlled Substances Act does not allow refills for Schedule II drugs, forcing many doctors to give multiple prescriptions or to have patients with chronic conditions return regularly. "We believe that the statement and proposed rule will help the medical professional ensure that only patients who need medication for pain relief get it," explained DEA administrator Karen Tandy in a written statement.

New approval for invasive fungal infections

Secondary wholesaler files suit against FDA

RxUSA Wholesale, Port Washington, N.Y., and other plaintiffs have filed an action seeking a declaratory judgment against the Department of Health & Human Services and the FDA. The plaintiffs are seeking a determination that the FDA rule (effective Dec. 1, 2006) interpreting a section of the Prescription Drug Marketing Act that exempts authorized distributors from providing pedigree information for pharmaceutical products (while requiring all others in the chain of distribution to provide such information) is unconstitutional. The action was filed in the Federal District Court, the Eastern District of New York. FDA spokeswoman Crystal Rice told Drug Topics, "We won't comment on litigation matters." This suit follows an earlier one that RxUSA Wholesale had filed against select manufacturers and distributors for allegedly boycotting secondary wholesalers.

Wal-Mart fires first shot in generic price war

In a move that promises to shake up the retail pharmacy industry, Wal-Mart announced that it will charge only $4 for 291 generic prescription drugs at 65 locations in the Tampa Bay, Fla., area. The company expects to expand the program to the rest of Florida in January 2007 and nationwide later in 2007. Target quickly responded with a short announcement that it would meet Wal-Mart's prices on the same drugs. Bill Simon, Wal-Mart executive VP of professional services, said the cost savings will come from the company's ability to cut costs in its supply chain and that the company has not negotiated special pricing with any manufacturers or distributors. He also insisted that the low prices were not a "loss leader" to get people into the store. Still, as some critics note, most of the 291 medications are relatively inexpensive older generics and may not have a big impact. "The real question is what happens next," explained Steven Findlay, healthcare analyst at Consumers Union. "We would expect that virtually every pharmacy chain will consider meeting this in the coming months. It's a big challenge."

Two pharmacies gain compounding accreditation

The Apothecary Shops and the Compounding Shoppe are the first pharmacies to earn the Pharmacy Compounding Accreditation Board Seal of Accreditation. To earn PCAB accreditation, the pharmacies were required to submit to on-site inspections as well as an analysis of their quality procedures. More than 80 applications for accreditation have been submitted and are under review. "With the high volume of prescriptions compounded each year, there has been a need for an enhanced, professionwide system of standards by which each compounding pharmacy can test its quality processes," said Ken Baker, PCAB executive director. "While compounding is regulated by state, PCAB accreditation is an even more comprehensive way to ensure a compounding pharmacy is meeting the highest quality safety standards."