Although generic drug industry leaders have been lobbying Congress extensively for legislation to speed the approval of biogenerics, the latest bill to address that issue is drawing harsh criticism from the Generic Pharmaceutical Association (GPhA).
That proposal, the "Pathway Act to Biosimilars" sponsored by Reps Anna Eshoo (D, CA) and Joe Barton (R, TX), "is a pathway to the wrong destination for patients in need of safe and affordable biogenerics," GPhA President and Chief Executive Officer Kathleen Jaeger said. "At best," the proposed legislation "is a disappointing distraction that does nothing to advance legislation. At worst, it's a step backwards that puts brand company profits before patient needs," she said.
GPhA is particularly opposed to what the association described as "unwarranted and unprecedented market exclusivity or patent extension provisions" in the bill. Among other things, the legislation would grant branded manufacturers of biologics "an unjustifiable 14.5 years of market exclusivity beyond the years companies already have under their existing patents," a GPhA official said.
Such counter-detailing programs have already been launched by "several states to deliver objective educational material to doctors about affordable treatment options, including the use of generic medicines," a generic industry spokesman said.
Under programs in operation in states such as Florida, Pennsylvania, and West Virginia, physicians are provided with information about generics, diet, and lifestyle changes as alternatives to medication. According to one study, the program underway in Pennsylvania saved that state's taxpayers about $572,000 a year on heartburn drugs alone.
"We are excited about this acquisition, as this facility provides us with a profitable revenue base built on strong customer relationships with branded and generic companies," noted Mark Hartman, president of North America Generics at Dr. Reddy's. "It also provides us with an additional platform to further expand our prescription generic and OTC capabilities, and our general product portfolio as well."
The OIG's June report notes that the FDA's Office of Generic Drugs generally follows a first-in, first-reviewed policy for ANDAs, rather than first reviewing clear-cut applications that do not involve patents or exclusivity issues that complicate the process.
In comments to the draft report, FDA noted that it has already identified portions of the primary recommendations and is implementing process improvements that are the same as or similar to the recommendations.
The full report can be accessed at www.oig.hhs.gov/oei/reports/oei-04-07-00280.pdf.
Generic drug maker Teva Pharmaceutical Industries Ltd is increasing its presence in the European pharmaceutical market through an agreement to buy the generic pharmaceutical operations of Bentley Pharmaceuticals Inc for $360 million.
Exeter, New Hampshire?based Bentley is a leading marketer of generic drugs in Spain and also sells to other European Union countries. Officials at Teva said the acquisition will give their company a ?platform to capture a leading position in the fast-growing Spanish generic pharmaceutical market.? A strategic review conducted by Teva last year identified Spain as one of the company?s target markets for future growth.