PHARMACY

Pair of Congress leaders advocate on behalf of community pharmacy

BY Michael Johnsen

ALEXANDRIA, Va. — Reps. Doug Collins, R-Ga., and Martha Roby, R-Ala., on Tuesday advocated for community pharmacy with letters addressed to the leaders of the House Energy and Commerce Committee and Ways and Means Committee. 

In serving Medicare seniors, community pharmacies should be subject to the same three-year audit review period as hospitals, and not forced to document 10-year-old claims, the Representatives suggested.  

“Patients rely on their independent community pharmacists to ensure proper medication use, to guard against drug interactions and to help take advantage of lower-cost generic drugs, where appropriate,” said NCPA CEO Douglas Hoey. “These pharmacists should not face needless distractions to patient care, such as documenting why they filled a prescription a decade ago. We appreciate Reps. Collins and Roby taking the time to not only meet with some of the pharmacy small business owners that they represent, but for also registering their concern with the appropriate committee leaders.”

“A few weeks ago I was back in my district and had the opportunity to visit with several small pharmacy owners and their employees about issues they face and deal with every day," Collins wrote. "It was very concerning for me to hear the struggles and lack of leverage these constituents face when conducting business with large pharmacy benefit managers.”

"One could question why PBMs need 10 years to begin an audit,” Roby suggested. “Precedent for a shorter look-back already exists within the Medicare RAC process.” 

She also urged the committees to examine PBM auditing methods, a shorter look-back period and what percentage of funds recouped from pharmacies by auditors are actually returned to the Medicare trust fund. In addition, Rep. Roby expressed concern that “pharmacies are frequently reimbursed below their cost to dispense drugs,” and that PBM payment benchmarks for generic drugs are not updated frequently enough to avoid “artificially decreasing pharmacy drug reimbursements.”

Twenty-nine states have enacted legislation setting common-sense standards for pharmacy audits, NCPA noted. The Medicare Prescription Drug Program Integrity and Transparency Act (S. 867), introduced by Sens. Mark Pryor, D-Ark., and Jerry Moran, R-Kan., would implement similar reforms at the federal level, ensure that legitimately recouped funds are passed through to the plan sponsor (such as Medicare) and ban 10-year-old audits.

 

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PHARMACY

Senate passes Drug Quality and Security Act

BY Alaric DeArment

NEW YORK — A bill that would implement federal tracking and tracing of drugs and strengthen federal regulations on pharmacy compounding has passed in the Senate and will go to President Barack Obama for his signature.

The Senate passed via voice vote the Drug Quality and Security Act, which would give the Food and Drug Administration new authority in the so-called downstream supply chain, which refers to the path drugs take from manufacturers to providers and patients, complementing the agency’s regulatory power over the upstream supply chain, the path they take from raw materials to finished products.

Another provision of the bill would grant the FDA new power to regulate compounding pharmacies that produce large volumes of drugs without individual prescriptions, while distinguishing between sterile compounding of injected drugs and traditional compounding of products like mouthwashes and topical ointments. That provision was designed to address the safety issues in compounding pharmacies that came to the public’s attention with last year’s fungal meningitis outbreak linked to the New England Compounding Center, in which hundreds of patients were sickened and dozens died.

The bill’s passage received praise from Washington-based trade organizations.

The National Association of Chain Drug Stores noted that the bill "establishes one national standard for supply-chain regulation as opposed to an unworkable patchwork of state laws and regulations," and noted the "significant investments" chain pharmacy retailers have made in the safety of the U.S. drug distribution system.

"The passage of this bill will help ensure the health and safety of patients," NACDS president and CEO Steve Anderson said. "This is a large step in helping avoid such tragedies as last year’s national meningitis outbreak."

Meanwhile, the HDMA, which represents primary healthcare distributors, also praised the replacement of a 50-state patchwork of regulations with a single federal one.

"Today, the Senate voted to establish a national traceability framework for prescription medicines," HDMA president and CEO John Gray said. "The federal preemption of state laws to further strengthen the U.S. pharmaceutical supply chain represents one of the most significant legislative accomplishments for our industry and is especially important for the healthcare providers and pharmacies and their patients who count on the safe and efficient distribution of prescription medicines."

The National Community Pharmacists Association highlighted the bill’s compounding provisions.

“When manufactured drugs are not an option, community pharmacists prepare, or compound, customized medications to meet a variety of individual health needs. H.R. 3204 leaves regulation of this vital and long-accepted practice by independent community pharmacies to state boards of pharmacy, where it should be," NCPA CEO B. Douglas Hoey said. "It also establishes a voluntary, regulatory pathway for companies to register as outsourcing facilities subject to standards and inspection by the Food and Drug Administration. Thus, the legislation should help prevent a recurrence of the tragic meningitis outbreak linked to the NECC, while preserving patient access to individual medications compounded by local pharmacies in response to a doctor’s request."

The Generic Pharmaceutical Association, a trade group representing generic drug manufacturers, also praised the bill.

“Establishing a predictable, reliable national standard for electronic prescription medicine tracking further safeguards our nation’s prescription drug supply and protects patients,” GPhA president and CEO Ralph Neas said. “This bipartisan bill is the culmination of years of hard work from Congress and stakeholders at every level of the supply chain. Modernizing the nation’s prescription drug tracking system enhances the ability of regulators to limit risks posed by counterfeit or adulterated products and reassures patients that the generic medicines they receive are secure from the manufacturer all the way to the pharmacy.”

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Actavis seeks approval for generic testosterone-replacement drug

BY Alaric DeArment

DUBLIN — Drug maker Actavis hopes to become the first to market with a generic version of a topical testosterone replacement drug marketed by Eli Lilly, Actavis said.

The generic drug maker it filed with the Food and Drug Administration for approval of testosterone topical solution in the 30-mg-per-1.5 mL strength, a generic version of Lilly’s Axiron. The drug is used as a replacement therapy for deficient or absent testosterone.

In response to the filing, Lilly and another company, Acrux, filed a patent-infringement suit against Actavis in the U.S. District Court for the Southern District of Indiana. The lawsuit puts an automatic stay of FDA approval on Actavis’ product for 30 months or until the companies settle the case. Actavis said it was the first company to file for FDA approval and expects to have 180 days in which to compete directly against Lilly’s product upon approval.

Axiron had sales of about $257 million during the 12-month period that ended in September, according to IMS Health.

 

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