PHARMACY

NACDS claims victory for pharmacies, patients in South Carolina

BY Allison Cerra

ALEXANDRIA, Va. The National Association of Chain Drug Stores praised a provision in legislation passed Thursday that will benefit South Carolina’s pharmacies.

The new provision will not hold pharmacies responsible for the recent average wholesale price First DataBank/Medi-Span settlements and — pending approval from the Centers for Medicare and Medicaid Services — sets pharmacy reimbursement at wholesale acquisition cost plus (+)12.5%. The law also calls for an adjustment to the Medicaid dispensing fee should the federal AMP provision become problematic for pharmacies in South Carolina.

The FirstDataBank/Medi-Span settlements refer to litigation surrounding the publishing of drug pricing data. The effect of the settlements is to change these data in a way that harms pharmacies, even though they were not parties in the litigation.

NACDS president and CEO Steve Anderson called the passage “a monumental achievement for pharmacy and patients” in the state.

“The excessive rate cuts originally imposed placed a significant burden on pharmacies. The increased reimbursement rate will help preserve access to community pharmacies and maintain the vital pharmacist-patient relationship. This helps to foster medication adherence, which refers to patients’ taking their medications correctly, and that maintains health and ultimately prevents the need for higher-cost forms of health care,” Anderson said.

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PHARMACY

Roxane gets nod for generic herpes treatment

BY Alaric DeArment

COLUMBUS, Ohio The Food and Drug Administration has approved a generic version of a drug for herpes made by Roxane Labs, Roxane said Wednesday.

The FDA approved Roxane’s valacyclovir hydrochloride tablets in the 500-mg and 1-g strengths. The drug, which is a version of GlaxoSmithKline’s Valtrex, is used to treat genital herpes, cold sores and herpes zoster.

Valacyclovir hydrochloride tablets in the 500-mg and 1-g strengths had sales of $2.13 billion in 2009, according to IMS Health.

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GPhA responds to FTC’s attempt to quash ‘pay-for-delay’ deals

BY Alaric DeArment

WASHINGTON The Federal Trade Commission again is going after settlements between branded and generic drug companies that it calls anticompetitive, the agency said.

In testimony Wednesday before the Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights, FTC chairman Jon Leibowitz spoke of the FTC’s goal of eliminating the patent settlements, which it derides as “pay-for-delay” deals. “Years of experience have proven that competitive markets work better than anything else to bring consumers lower prices, greater innovation and more choices among products and services,” Leibowitz said.

In a typical patent settlement scenario, a generic drug company will challenge a brand company’s patent on a drug by filing a regulatory approval application for a generic version with the Food and Drug Administration containing a Paragraph IV certification. Provided for under the Hatch-Waxman Act of 1984, the law that created an abbreviated approval pathway for generic drugs, a Paragraph IV certification is a legal assertion that the patent is invalid, unenforceable or won’t be infringed by a generic version of the drug.

The brand drug company typically will respond with a patent infringement suit, and often, rather than going to trial, the two companies will reach a settlement whereby the generic drug company agrees to hold off launching its version in exchange for the brand company paying money or agreeing not to launch an “authorized generic,” essentially the branded drug sold under its generic name at a discount. But in most cases, the settlements allow the generic company to launch its version months, or even years, ahead of the patent expiration.

The Generic Pharmaceutical Association, an industry lobbying group that has long criticized the FTC on the issue of patent settlements, lashed out at Leibowitz’s testimony. “Following the testimony today by commissioner Leibowitz before a Senate judiciary subcommittee, GPhA feels compelled to set the record straight,” GPhA president and CEO Kathleen Jaeger said. “The fact is that it is patents, not settlements, that protect the brands from generic competition. Despite claims to the contrary, settlements actually help bring affordable generic medicines to market sooner, to the benefit of consumers and the healthcare system.”

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