Senate passes Drug Quality and Security Act
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.”
Actavis seeks approval for generic testosterone-replacement drug
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.
Upsher-Smith to present phase-3 trial data of experimental epilepsy drug
MAPLE GROVE, Minn. – Drug maker Upsher-Smith Labs will present data from a late-stage trial of a drug for treating epilepsy, the company said Monday.
Upsher-Smith’s presentation of data from a phase-3 clinical trial of USL255 (topiramate extended-release) will take place at the American Epilepsy Society’s 67th annual meeting in Washington, which lasts from Dec. 6-10. Seven presentations will highlight results from the "PREVAIL" trial, while two additional presentations will feature phase-1 trial data on pharmacokinetics of USL255 when sprinkled onto food or swallowed intact.
"This year’s AES meeting marks the first time the findings from our phase-3 trial will be presented publicly," Upsher-Smith chief scientific officer William Pullman said. "We look forward to sharing data from the first global phase-3 clinical trial of an extended-release formulation of topiramate with the epilepsy community at this year’s annual meeting."