News Capsules

JULY 01, 2008


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.


With branded pharmaceutical companies spending an estimated $30 billion to promote their products to prescribers and patients, government agencies responsible for holding down health costs should fight back with "counter-detailing" to promote the use of less expensive generic drugs. At least that is the view expressed by generic industry leaders, as the Senate Special Committee on Aging debated such an initiative on Capitol Hill.

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.


Dr. Reddy's Laboratories recently announced the acquisition of BASF's pharmaceutical contract manufacturing business, a move that includes the relevant business, customer contracts, related new drug applications, and trademarks, as well as BASF's manufacturing facility and assets in Shreveport, Louisiana. This business involves the contract manufacturing of generic prescription and OTC products for branded and generic companies in the United States. The facility is designed to manufacture solid, semisolid, and liquid dosage forms.

"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."


A recent study by the Department of Health and Human Services Office of Inspector General (OIG) found that the FDA exceeded the 180-day review requirement for nearly half of Abbreviated New Drug Applications (ANDAs) for generic drugs in 2006, and it is recommending that the agency improve its record by changing the way it prioritizes these applications.

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


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.